Clincosm LogoSign in Get a demo

SELECTION: Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02914522
Collaborator
Galapagos NV (Industry)
1,351
Enrollment
343
Locations
11
Arms
40.5
Actual Duration (Months)
3.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1351 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date :
Nov 14, 2016
Actual Primary Completion Date :
Mar 31, 2020
Actual Study Completion Date :
Mar 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Induction Study (Cohort A): Filgotinib 200 mg

Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks.

Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

    • Drug: PTM filgotinib
    Tablet(s) administered orally once daily
    Experimental: Induction Study (Cohort A): Filgotinib 100 mg

    Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.

    Drug: Filgotinib
    Tablet(s) administered orally once daily
    Other Names:
  • GS-6034
  • GLPG0634

    • Drug: PTM filgotinib
    Tablet(s) administered orally once daily
    Placebo Comparator: Induction Study (Cohort A): Placebo

    Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

    Drug: PTM filgotinib
    Tablet(s) administered orally once daily
    Experimental: Induction Study (Cohort B): Filgotinib 200 mg

    Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

    Drug: Filgotinib
    Tablet(s) administered orally once daily
    Other Names:
  • GS-6034
  • GLPG0634

    • Drug: PTM filgotinib
    Tablet(s) administered orally once daily
    Experimental: Induction Study (Cohort B): Filgotinib 100 mg

    Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.

    Drug: Filgotinib
    Tablet(s) administered orally once daily
    Other Names:
  • GS-6034
  • GLPG0634

    • Drug: PTM filgotinib
    Tablet(s) administered orally once daily
    Placebo Comparator: Induction Study (Cohort B): Placebo

    Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

    Drug: PTM filgotinib
    Tablet(s) administered orally once daily
    Experimental: Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg

    Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg for an additional 47 weeks (up to Week 58).

    Drug: Filgotinib
    Tablet(s) administered orally once daily
    Other Names:
  • GS-6034
  • GLPG0634

    • Drug: PTM filgotinib
    Tablet(s) administered orally once daily
    Placebo Comparator: Maintenance Study: Placebo From Induction Filgotinib 200 mg

    Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).

    Drug: PTM filgotinib
    Tablet(s) administered orally once daily
    Experimental: Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg

    Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg for an additional 47 weeks (up to Week 58).

    Drug: Filgotinib
    Tablet(s) administered orally once daily
    Other Names:
  • GS-6034
  • GLPG0634

    • Drug: PTM filgotinib
    Tablet(s) administered orally once daily
    Placebo Comparator: Maintenance Study: Placebo From Induction Filgotinib 100 mg

    Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).

    Drug: PTM filgotinib
    Tablet(s) administered orally once daily
    Placebo Comparator: Maintenance Study: Placebo From Induction Placebo

    Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib for an additional 47 weeks (up to Week 58).

    Drug: PTM filgotinib
    Tablet(s) administered orally once daily

    Outcome Measures

    Primary Outcome Measures

    1. Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10 [Week 10]

      EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.

    2. Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58 [Week 58]

      EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.

    Secondary Outcome Measures

    1. Induction Study: Percentage of Participants Who Achieved MCS Remission at Week 10 [Week 10]

      MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.

    2. Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10 [Week 10]

      Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).

    3. Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 10 [Week 10]

      Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of <= 0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).

    4. Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10 [Week 10]

      MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.

    5. Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845 [Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10]

      Cmax is defined as the maximum observed concentration of drug.

    6. Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845 [Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10]

      Tmax is defined as the time to reach maximum observed concentration of drug.

    7. Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984 [Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10]

      AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

    8. Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984 [Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10]

      AUClast is defined as the concentration of drug from time zero to the last observable concentration.

    9. Induction Study: PK Parameter: Ctau of Filgotinib and Its Metabolite GS-82984 [Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10]

      Ctau is defined as the observed drug concentration at the end of the dosing interval.

    10. Maintenance Study: Percentage of Participants Who Achieved MCS Remission at Week 58 [Week 58]

      MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA. The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.

    11. Maintenance Study: Percentage of Participants Who Achieved Sustained EBS Remission at Week 58 [Week 58]

      Sustained EBS remission was defined as having achieved EBS remission at both Weeks 10 and 58.

    12. Maintenance Study: Percentage of Participants Who Achieved 6-Month Corticosteroid-Free EBS Remission at Week 58 [Week 58]

      Six-month corticosteroid-free EBS remission at Week 58 was defined as achieving EBS remission with no corticosteroid use for the indication of ulcerative colitis for at least 6 months prior to Week 58.

    13. Maintenance Study: Percentage of Participants Who Achieved Endoscopic Subscore of 0 at Weeks 58 [Week 58]

      Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).

    14. Maintenance Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 58 [Week 58]

      Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of <= 0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).

    15. Maintenance Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 58 [Week 58]

      MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.

    16. Maintenance Study: Plasma Concentration of Filgotinib and Its Metabolite GS-829845 [Week 26 (any Time) and Week 58 (predose)]

      Plasma concentration is defined as the measured drug concentration of filgotinib and its metabolite GS-829845. Lower limit of quantitation (LLOQ) was defined as 1 ng/mL for analyte filgotinib and 2 ng/mL for analyte GS-829845.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit

    • Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC.

    • A surveillance colonoscopy is required at screening in individuals with a history of UC for 8 or more years, if one was not performed in the prior 24 months

    • Moderately to severely active UC

    • Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab

    Key Exclusion Criteria:

    • Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon

    • Active tuberculosis (TB) or history of latent TB that has not been treated

    • Use of any concomitant prohibited medications as described in the protocol

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Digestive Health Specialists of the Southeast Dothan Alabama United States 36305
    2 Mayo Clinic Arizona Scottsdale Arizona United States 85259
    3 VA Long Beach Healthcare System Long Beach California United States 90822
    4 Cedars Sinai Medical Center Los Angeles California United States 90048
    5 South Denver Gastroenterology, PC Lone Tree Colorado United States 80124
    6 Connecticut GI PC-Research Division Farmington Connecticut United States 06032
    7 UF Health at Shands Hospital Gainesville Florida United States 32610
    8 Florida Research Institute Lakewood Ranch Florida United States 34211
    9 University of Miami Crohn's and Colitis Center Miami Florida United States 33136
    10 Cordova Research Institute Miami Florida United States 33155
    11 Gastroenterology Group of Naples Naples Florida United States 34102
    12 Advanced Medical Research Center Port Orange Florida United States 32127
    13 Tampa General Hospital Tampa Florida United States 33606
    14 Shafran Gastroenterology Center Winter Park Florida United States 32789
    15 Florida Medical Clinic, P.A. Zephyrhills Florida United States 33540
    16 Gastroenterology Associates of Central Georgia, LLC Macon Georgia United States 31201
    17 Gastrointestinal Specialists of Georgia Marietta Georgia United States 30060
    18 Atlanta Gastroenterology Specialist, PC Suwanee Georgia United States 30024
    19 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    20 University of Louisville, Clinical Trials Unit Louisville Kentucky United States 40202
    21 Delta Research Partners, LLC Monroe Louisiana United States 71201
    22 Louisiana Research Center, LLC Shreveport Louisiana United States 71105
    23 Investigative Clinical Research Annapolis Maryland United States 21401
    24 MGG Group Co., Inc., Chevy Chase Clinical Research Chevy Chase Maryland United States 20815
    25 Gastro Center of Maryland Columbia Maryland United States 21045
    26 Meritus Center for Clinical Research Hagerstown Maryland United States 21742
    27 Massachusetts General Hospital - Crohn's and Colitis Center Boston Massachusetts United States 02114
    28 Clinical Research Institute of Michigan, LLC Chesterfield Michigan United States 48047
    29 Center for Digestive Health Troy Michigan United States 48098
    30 Mayo Clinic Rochester Minnesota United States 55905
    31 Kansas City Research Institute Kansas City Missouri United States 64131
    32 Washington University School of Medicine Saint Louis Missouri United States 63110
    33 NY Scientific Brooklyn New York United States 11235
    34 NYU Langone Long Island Clinical Research Associates Great Neck New York United States 11021
    35 Carolina's GI Research, LLC Raleigh North Carolina United States 27607
    36 Fargo Gastroenterology and Hepatology Clinic Fargo North Dakota United States 58103
    37 Consultants for Clinical Research Cincinnati Ohio United States 45219
    38 UC Health Physicians Clifton Cincinnati Ohio United States 45219
    39 Great Lakes Gastroenterology Research, LLC Mentor Ohio United States 44060
    40 Gastroenterology Associates of Orangeburg Orangeburg South Carolina United States 29118
    41 Rapid City Medical Center Rapid City South Dakota United States 57701
    42 WR-ClinSearch, LLC Chattanooga Tennessee United States 37421
    43 Gastro One Germantown Tennessee United States 38138
    44 Quality Medical Research Nashville Tennessee United States 37211
    45 Vanderbilt University Medical Center - IBD Clinic Nashville Tennessee United States 37212-1375
    46 San Antonio Military Medical Center Fort Sam Houston Texas United States 78219
    47 DHAT Research Institute Garland Texas United States 75044
    48 Baylor College of Medicine- Baylor Medical Center Houston Texas United States 77030
    49 The University of Texas Health Science Center at Houston Houston Texas United States 77030
    50 Clinical Associates in Research Therapeutics of America, LLC San Antonio Texas United States 78212
    51 Gastroenterology Research of San Antonio San Antonio Texas United States 78229
    52 Texas Digestive Disease Consultants San Marcos Texas United States 78666
    53 Texas Digestive Disease Consultants Southlake Texas United States 76092
    54 Spring Gastroenterology The Woodlands Texas United States 77380
    55 HP Clinical Research Bountiful Utah United States 84010
    56 University of Virginia Health System Charlottesville Virginia United States 22908
    57 Gastroenterology Associates Of Tidewater Chesapeake Virginia United States 23320
    58 Emeritas Research Group LLC Lansdowne Town Center Virginia United States 20176
    59 McGuire DVAMC Richmond Virginia United States 23249
    60 University of Wisconsin Hospital & Clinics Madison Wisconsin United States 53705
    61 Allegiance Research Specialists, LLC Wauwatosa Wisconsin United States 53225
    62 Instituto de Investigaciones Clinicas Mar del Plata Mar del Plata Argentina B7600FZN
    63 Instituto Médico Cer Quilmes Argentina B1878
    64 St. Vincent's Hospital Sydney Darlinghurst New South Wales Australia 2010
    65 Nepean Hospital Kingswood New South Wales Australia 2747
    66 Coastal Digestive Health Mountain Creek Queensland Australia 4557
    67 Mater Misericordiae Ltd South Brisbane Queensland Australia 4101
    68 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
    69 The Queen Elizabeth Hospital Woodville South South Australia Australia 5011
    70 Monash Medical Centre Clayton Victoria Australia 3168
    71 Footscray Hospital Footscray Victoria Australia 3011
    72 Austin Health Heidelberg Victoria Australia 3084
    73 Cabrini Hospital Malvern Victoria Australia 3144
    74 Alfred Hospital Melbourne Victoria Australia 3004
    75 Universitatsklinik Innsbruck Innsbruck Austria 6020
    76 AKH-Medizinische Universitat Wien Wien Austria 1090
    77 GZA Ziekenhuizen campus Sint-Vincentius Antwerpen Belgium 2018
    78 CUB Hopital Erasme Brussels Belgium 1070
    79 Universitair Ziekenhuis Leuven Leuven Belgium B-3000
    80 Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph Liège Belgium 4000
    81 MHAT Sveti Pantaleymon - Pleven OOD Pleven Bulgaria 5800
    82 "MDHAT Dr. St.Cherkezov" AD Veliko Tŭrnovo Bulgaria 5000
    83 MHAT "Sveta Petka" AD Vidin Bulgaria 3700
    84 University of Calgary, Heritage Medical Research Clinic Calgary Alberta Canada T2N 4Z6
    85 The Gordon and Leslie Diamond Health Care Centre Vancouver British Columbia Canada V5Z 1M9
    86 Hamilton Health Sciences Corporation, McMaster University Medical Centre Hamilton Ontario Canada L8S 4K1
    87 Royal University Hospital Saskatoon Saskatchewan Canada S7N 0W8
    88 Toronto Digestive Disease Associates Inc. Vaughan Canada L4L 4Y7
    89 Clinical Hospital Dubrava Zagreb Croatia 10000
    90 University Hospital Center Zagreb Zagreb Croatia 10000
    91 Hepato-Gastroenterologie HK, s.r.o. Hradec Kralove Czechia 500 12
    92 Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni Mladá Boleslav Czechia 293 01
    93 G.E.P. Clinic, s r.o. Praha 3 Czechia 130 00
    94 ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety Praha 9 Czechia 190 00
    95 CHU Amiens Picardie Amiens France 80054
    96 CHU de Caen Caen France 14033
    97 CHU de Clermont-Ferrand - Hopital d'Estaing Clermont-Ferrand France 63003
    98 APHP - Hopital Beaujon - Clichy - Universite Paris VII Clichy France 92110
    99 CHU de Dijon Bourgogne - Hopital Francois Mitterand Dijon France 21079
    100 CHU Grenoble Alpes La Tronche France 38700
    101 Hopital Universitaire de Bicetre Le Kremlin-Bicêtre France 94270
    102 Centre Hospitalier Regional Universitaire de Lille Lille France 59000
    103 Hopital Nord Marseille France 13015
    104 CHU de Montpellier-Hopital Saint Eloi Montpellier France 34295
    105 CHU Hotel-Dieu Nantes France 44093
    106 Hopital de l'Archet 2 Nice France 06202
    107 Institut Mutualiste Montsouris Paris France 75014
    108 CHU de Bordeaux - Hopital Haut Leveque Pessac France 33600
    109 Centre Hospitalier Universitaire de Lyon Sud Pierre-Benite France 69495
    110 Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes Cedex 9 France 35033
    111 CHU de Saint-Etienne - Hopital Nord Saint Priest en Jarez France 42055
    112 CHU de Toulouse - Hopital Rangueil Toulouse France 31059
    113 CHU de Nancy - Hopital Brabois Adultes Vandœuvre-lès-Nancy France 54511
    114 Unimed Ajara LLC - Batumi Referral Hospital Batumi Georgia 6010
    115 Medi Club Georgia LLC Tbilisi Georgia 0160
    116 Ltd. Unimed Kakheti - Telavi Referral Hospital Telavi Georgia 2200
    117 Charite Universitatsmedizin Berlin Berlin Germany 10117
    118 Charite - Universitatsmedizin Berlin Berlin Germany 13353
    119 DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin Berlin Germany 14050
    120 Stadtisches Klinikum Braunschweig gGmbH Braunschweig Germany 38126
    121 Agaplesion Markus Krankenhaus Frankfurt am Main Germany 60431
    122 Universitatsklinikum Freiburg Freiburg Germany 79106
    123 Asklepios Westklinikum Hamburg Hamburg Germany 22559
    124 Medizinische Hochschule Hannover Hannöver Germany 30625
    125 Gastroenterologische Gemeinschaftspraxis Herne Herne Germany 44623
    126 Universitatsklinikum Jena Jena Germany 07747
    127 Universitatsklinikum Schleswig-Holstein Kiel Germany 24105
    128 Universitaetsklinik Koln Koln Germany 50937
    129 EUGASTRO GmbH Leipzig Germany 04103
    130 Klinikum Luneburg Lüneburg Germany 21339
    131 Gastroenterologische Gemeinschaftspraxis Minden Minden Germany 32423
    132 Klinikum der Universitat Munchen - Grosshadern Muenchen Germany 81377
    133 Universitaetsklinikum Tuebingen Tuebingen Germany 72074
    134 Universitatsklinikum Ulm, Zentrum Fur Innere Medizin Ulm Germany 89081
    135 General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit Athens Greece 11527
    136 General Hospital of Nikaias "Agios Pentelleimon", Gastroenterology Department Athens Greece 18454
    137 Princess Margaret Hospital Hong Kong Hong Kong
    138 Queen Mary Hospital Hong Kong Hong Kong
    139 Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital Sha Tin Hong Kong
    140 Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo Budapest Hungary 1097
    141 Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly Budapest Hungary 1125
    142 Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia Békéscsaba Hungary 5600
    143 Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia Debrecen Hungary 4032
    144 Bugat Pal Korhaz, Belgyogyaszat Gyöngyös Hungary 3200
    145 Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia Mosonmagyaróvár Hungary 9200
    146 Kaizen Hospital Ahmedabad India 380052
    147 M S Ramaiah Medical College and Hospital Bangalore India 560054
    148 Apollo Speciality Hospital Chennai India 600035
    149 VGM Hospital Institute of Gastroenterology Coimbatore India 641005
    150 Gleneagles Global Hospitals Hyderabad India 500004
    151 Citizens Specialty Hospital Hyderabad India 500019
    152 Centre for Liver Research & Diagnostics Hyderabad India 500058
    153 S.R.KallaMemorial Gastro.&General Hospital, Jaipur India 302001
    154 S.M.S Medical College & Hospitals Jaipur India 302004
    155 School of Digestive & Liver Diseases Kolkata India 700020
    156 Dayanand Medical College & Hospital Ludhiana India 141001
    157 Kasturba Medical College (KMC) Hospital Mangaluru India 575001
    158 Lokmanya Tilak Municipal General Hospital Mumbai India 400022
    159 Midas Multispeciality Hospital Pvt. Ltd Nagpur India 400010
    160 Suretech Hospital & Research Centre Ltd Nagpur India 440012
    161 All India Institute of Medical Sciences New Delhi India 110029
    162 Grant Medical Foundation Ruby Hall Clinic Pune India 411001
    163 Shree Giriraj Multispeciality Hospital Rajkot India 360005
    164 Gandhi Hospital Secunderabad India 500003
    165 Institute of Gastroenterology & Liver Disease, Sunshine Hospitals Secunderabad India 500003
    166 Surat Institute of Digestive Sciences Surat India 395002
    167 Kasturba Hospital Medical College Udupi India 576104
    168 Sterling Hospital Vadodara India 390007
    169 Samvedana Hospital Varanasi India 221005
    170 Beaumont Hospital Dublin Ireland 9
    171 Soroka Medical Center Beer-Sheva Israel 8410101
    172 Bnai Zion Medical Center Haifa Israel 31048
    173 Rambam Health Care Campus Haifa Israel 3109601
    174 Shaare Zedek Medical Center Jerusalem Israel 9103102
    175 Hadassah Medical Center Jerusalem Israel 91120
    176 Rabin Medical Center Petach Tikva Israel 4941492
    177 UOC Gastroenterologia II Castellana Grotte Italy Bari 70013
    178 U.O. Fisiopatologia Digestiva Catanzaro Italy 88100
    179 Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina Chieti Italy 66100
    180 Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico Milano Italy 20121
    181 UOC Gastroenterologia Padova Italy 35128
    182 Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello Pisa Italy 56124
    183 UOC Gastroenterologia ed Endoscopia Digestiva Roma Italy 128
    184 Istituto Clinico Humanitas Rozzano Italy 20089
    185 Medical Hospital, Tokyo Medical and Dental University Bunkyo-ku Japan 113-8519
    186 Fukuoka University Chikushi Hospital Chikushino-shi Japan 818-8502
    187 Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital Chuo-Ku Japan 060-0033
    188 Japanese Red Cross Fukuoka Hospital Fukuoka-shi Japan 815-8555
    189 Tokai University Hachioji Hospital Hachioji-shi Japan 192-0032
    190 Hiroshima University Hospital Hiroshima-shi Japan 734-8551
    191 Fukuoka University Hospital Jonan-ku Japan 814-0180
    192 Ofuna Chuo Hospital Kamakura Japan 247-0056
    193 Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center Kitakyushu-shi Japan 802-0077
    194 Yamanashi Prefectural Central Hospital Kofu-shi Japan 400-8506
    195 Kurume University Hospital Kurume-shi Japan 830-0011
    196 Hidaka Coloproctology Clinic Kurume-shi Japan 839-0809
    197 University Hospital, Kyoto Prefectural University of Medicine Kyoto-shi Japan 602-8566
    198 The Jikei University Hospital Minato-Ku Japan 105-8471
    199 Kitasato University Kitasato Institute Hospital Minato-ku Japan 108-8642
    200 Kyorin University Hospital Mitaka-shi Japan 181-8611
    201 Iwate Medical University Hospital Morioka-shi Japan 020-8505
    202 Aichi Medical University Hospital Nagakute-shi Japan 480-1195
    203 Nagasaki University Hospital Nagasaki-shi Japan 852-8501
    204 Saiseikai Niigata Daini Hospital Nishi-ku Japan 950-1104
    205 Hyogo College of Medicine College Hospital Nishinomiya Japan 663-8501
    206 Ishida IBD Clinic Oita-shi Japan 870-0823
    207 Okayama University Hospital Okayama-city Japan 700-8558
    208 Wakakusa-Daiichi Hospital Osaka Japan 579-8056
    209 Saga-Ken Medical Centre Koseikan Saga-shi Japan 840-8571
    210 Kitasato University Hospital, THE KITASATO INSTITUTE Sagamihara Japan 252-0375
    211 Saga University Hospital Saga Japan 849-8501
    212 Tokito Clinic Saitama Japan 336-0963
    213 Toho University Sakura Medical Center Sakura Japan 285-8741
    214 Sapporo Higashi Tokushukai Hospital Sapporo-shi Japan 065-0033
    215 Sapporo Tokushukai Hospital Sapporo Japan 004-0041
    216 National Hospital Organization Sendai Medical Center Sendai Japan 983-8520
    217 Tokyo Yamate Medical Center Shinjuku-ku Japan 169-0073
    218 Osaka University Hospital Suita Japan 565-0871
    219 Kagawa Prefectural Central Hospital Takamatsu-shi Japan 760-8557
    220 National Hospital Organization Takasaki General Medical Center Takasaki-shi Japan 3700829
    221 Osaka Medical College Hospital Takatsuki Japan 569-8686
    222 Ieda Hospital Toyota-shi Japan 470-1219
    223 Wakayama Medical University Hospital Wakayama-shi Japan 641-8509
    224 Colo-proctology Center Matsushima Clinic Yokohama-shi Japan 220-0045
    225 Yokohama Health Medicine Association Kannai Suzuki Clinic Yokohama-shi Japan 231-0012
    226 Kinshukai Infusion Clinic Ōsaka Japan 530-0011
    227 Osaka City University Hospital Ōsaka Japan 545-8586
    228 Shiga University of Medical Science Hospital Ōtsu Japan 520-2912
    229 The Catholic University of Korea, St. Vincent's Hospital Suwon-si Gyeonggi-do Korea, Republic of 16247
    230 Pusan National University Hospital Busan Korea, Republic of 609801
    231 Yeungnam University Hospital Daegu Korea, Republic of 42415
    232 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181
    233 Yonsei University Health System, Severance Hospital Seoul Korea, Republic of 03722
    234 Asan Medical Center Seoul Korea, Republic of 05505
    235 Division of Gastroenterology, Department of Medicine, Samsung Medical Center Seoul Korea, Republic of 06351
    236 Hyung Hee University Hospital Seoul Korea, Republic of 130-872
    237 Yonsei University Wonju Severance Christian Hospital Wŏnju Korea, Republic of 220-701
    238 University Kebangsaan Malaysia Medical Centre Cheras Malaysia 56000
    239 Hospital Pulau Pinang George Town Malaysia 10990
    240 Hospital Queen Elizabeth Kota Kinabalu Malaysia 88586
    241 PCR-Phylasis Clinicas Research S. de R.L. de C.V. Cuautitlán Izcalli Mexico 54750
    242 Academic Medical Center (AMC) Amsterdam Netherlands 1100
    243 Gelre Hospital Apeldoorn Netherlands 7334
    244 University Medical Center Utrecht Utrecht Netherlands 3584 CX
    245 Christchurch Hospital Christchurch New Zealand 8011
    246 Auckland City Hospital Grafton New Zealand 1023
    247 Waikato Hospital Hamilton New Zealand 3240
    248 Wellington Hospital Newtown New Zealand WE 6021
    249 Bay of Plenty District Health Board - Tauranga Hospital Tauranga New Zealand 3134
    250 Vestre Viken Hospital Trust, Baerum Hospital Drammen Norway 1346
    251 Akerskus University Hospital Lørenskog Norway N-1478
    252 Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych Białystok Poland 15-276
    253 VITAMED Galaj i Cichomski spolka jawna Bydgoszcz Poland 85-079
    254 Gabinet Lekarski Janusz Rudzinski Bydgoszcz Poland 85-681
    255 NZOZ INTER-MED, Centrum Endoskopowe Częstochowa Poland 42-217
    256 Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS Katowice Poland 40-659
    257 Gabinet Endoskopii Przewodu Pokarmowego Kraków Poland 31-009
    258 Krakowskie Centrum Medyczne Sp. z o.o Kraków Poland 31-501
    259 Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J. Ksawerów Poland 95-054
    260 Centrum Innowacyjnych Terapii Sp. z o.o. Piaseczno Poland 05-500
    261 Clinical Research Center Spolka z organiczna odpowiedzialnoscia Medic-R Sp. k. Poznan Poland 60-848
    262 Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski Rzeszów Poland 35-301
    263 Endoskopia Sp. z o.o. Sopot Poland 81-756
    264 Twoja Przychodnia-Szczecinskie Centrum Medyczne Szczecin Poland 71-434
    265 GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii Toruń Poland 87-100
    266 H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K. Tychy Poland 43-100
    267 Centrum Zdrowia MDM Warszawa Poland 0-635
    268 Bodyclinic Warszawa Poland 00-332
    269 Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie Warszawa Poland 02-507
    270 Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz Warszawa Poland 03-580
    271 Centrum Medyczne Oporow Wroclaw Poland 52-416
    272 Santa Familia, Centrum Badan, Profilaktyki i Leczenia Łódź Poland 90-302
    273 Hospital da Senhora da Oliveira Guimaraes, E.P.E. Guimarães Portugal 4835-044
    274 Centro Hospitalar de Sao Joao, EPE Porto Portugal 4200-319
    275 SC MedLife SA, Gastroenterologie Bucuresti Romania 010719
    276 Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie Bucuresti Romania 020125
    277 Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie Oradea Romania 410066
    278 Cabinet Particular Policlinic Algomed SRL Timişoara Romania 300002
    279 State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital" Chelyabinsk Russian Federation 454076
    280 State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital Irkutsk Russian Federation 669079
    281 Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety Moscow Russian Federation 115446
    282 State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow" Moscow Russian Federation 127015
    283 State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy" Moscow Russian Federation 129110
    284 State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Nizhniy Novgorod Russian Federation 603126
    285 State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12" Novosibirsk Russian Federation 630084
    286 State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital" Novosibirsk Russian Federation 630087
    287 "Riat" LLC Saint Petersburg Russian Federation 193163
    288 "PolyClinic EXPERT" LLC Saint Petersburg Russian Federation 197110
    289 Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38" Saint-Petersburg Russian Federation 191015
    290 "Scientific Research Centre ECO-safety" LLC Saint-Petersburg Russian Federation 196143
    291 State Healthcare Institution "Regional Clinical Hospital" Saratov Russian Federation 410053
    292 Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC Smolensk Russian Federation 214019
    293 State Autonomous Health Institution of the Tyumen Region "Multidisciplinary Consultative and Diagnostic Center" Tyumen Russian Federation 625026
    294 Zvezdara University Medical Center Belgrade Serbia 3810-971
    295 Singapore General Hospital Singapore Singapore 169608
    296 KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra Nitra Slovakia 950 01
    297 Dr MJ Prins Cape Town South Africa 7500
    298 Peermed Clinical Trial Centre Johannesburg South Africa 1619
    299 Centro Medico Teknon Barcelona Spain 08022
    300 Hospital Clinico San Carlos Madrid Spain 28040
    301 Hospital Universitario de Fuenlabrada Madrid Spain 28942
    302 Hospital Universitario Central de Asturias Oviedo Spain 33006
    303 Hospital Universitario Virgen del Rocio Sevilla Spain 41013
    304 Danderyds Sjukhus AB Danderyd Sweden SE-18288
    305 Skane University Hospital Malmo Sweden SE-205-02
    306 Akademiska Sjukhuset Uppsala Sweden 75185
    307 Gastroenterologische Praxis Balsiger, Seibold und Partner Bern Switzerland 3012
    308 Universitatsspital Zurich Zürich Switzerland 8091
    309 Changhua Christian Hospital Chang-hua Taiwan 500
    310 National Taiwan University Hospital Taipei Taiwan 100
    311 Mackay Memorial Hospital, Taipei Taipei Taiwan 10449
    312 Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch Taoyuan Taiwan 33305
    313 Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department Cherkasy Ukraine 18000
    314 Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical Chernivtsi Ukraine 58000
    315 Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department Chernivtsi Ukraine 58000
    316 State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine" Dnipropetrovsk Ukraine 49000
    317 Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National Ivano-Frankivs'k Ukraine 76000-490
    318 Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department Kharkiv Ukraine 61037
    319 L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine" Kharkiv Ukraine 61039
    320 Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1 Kharkiv Ukraine 63101
    321 Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus" Kropyvnytskyi Ukraine 25006
    322 Kyiv City Clinical Hospital No. 18, Proctology Department Kyiv Ukraine 01030
    323 Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department Kyiv Ukraine 1103
    324 Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway" Odessa Ukraine 65010
    325 Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department Odessa Ukraine 65025
    326 Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology Ternopil Ukraine 46002
    327 Medical Center LLC "Health Clinic" Vinnytsia Ukraine 21029
    328 Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1 Vinnytsya Ukraine 21005
    329 M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department Vinnytsya Ukraine 21018
    330 Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council Zaporizhzhya Ukraine 69600
    331 The Pennine Acute Hospitals NHS Trust Bury United Kingdom BL9 7TD
    332 Cambridge University Hospital NHS Foundation Trust Cambridge United Kingdom CB2 0QQ
    333 Royal Derby Hospital Derby United Kingdom DE22 3NE
    334 NHS Lothian Edinburgh United Kingdom EH4 2XU
    335 Glasgow Clinical Research Facility - Queen Elizabeth University Hospital Glasgow United Kingdom G51 4TF
    336 NHS Greater Glasgow and Clyde Glasgow United Kingdom G52 3NQ
    337 Wycombe Hospital High Wycombe United Kingdom HP11 2TT
    338 Imperial College Healthcare NHS Trust, St Mary's Hospital London United Kingdom W2 1NY
    339 Norfolk and Norwich University Hospital NHS Foundation Trust Norwich United Kingdom NR4 7UY
    340 Biomedical Research Unit Nottingham United Kingdom NG7 2UH
    341 Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom OX3 9DU
    342 St Helens and Knowsley Teaching Hospitals NHS Trust Prescot United Kingdom L35 5DR
    343 Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility Southampton United Kingdom SO16 6YD

    Sponsors and Collaborators

    • Gilead Sciences
    • Galapagos NV

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02914522
    Other Study ID Numbers:
    • GS-US-418-3898
    • 2016-001392-78
    First Posted:
    Sep 26, 2016
    Last Update Posted:
    Apr 21, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colitis
    Colitis, Ulcerative
    Ulcer

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study sites in Australia, New Zealand, North America, South America, Asia and Europe. The first participant was screened on 14 November 2016. The last study visit occurred on 31 March 2020.
    Pre-assignment Detail 2040 participants were screened.
    Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Placebo
    Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
    Period Title: Induction Study: Up to Week 11
    STARTED 245 278 137 262 286 143 0 0 0 0 0
    COMPLETED 235 256 127 234 262 127 0 0 0 0 0
    NOT COMPLETED 10 22 10 28 24 16 0 0 0 0 0
    Period Title: Induction Study: Up to Week 11
    STARTED 0 0 0 0 0 0 202 99 179 91 93
    COMPLETED 0 0 0 0 0 0 150 41 104 42 64
    NOT COMPLETED 0 0 0 0 0 0 52 58 75 49 29

    Baseline Characteristics

    Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo Total
    Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Total of all reporting groups
    Overall Participants 245 277 137 262 285 142 1348
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    234
    95.5%
    261
    94.2%
    129
    94.2%
    243
    92.7%
    264
    92.6%
    128
    90.1%
    1259
    93.4%
    >=65 years
    11
    4.5%
    16
    5.8%
    8
    5.8%
    19
    7.3%
    21
    7.4%
    14
    9.9%
    89
    6.6%
    Sex: Female, Male (Count of Participants)
    Female
    122
    49.8%
    120
    43.3%
    50
    36.5%
    114
    43.5%
    99
    34.7%
    56
    39.4%
    561
    41.6%
    Male
    123
    50.2%
    157
    56.7%
    87
    63.5%
    148
    56.5%
    186
    65.3%
    86
    60.6%
    787
    58.4%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian or Alaska Native
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.1%
    Asian
    77
    31.4%
    79
    28.5%
    38
    27.7%
    50
    19.1%
    51
    17.9%
    27
    19%
    322
    23.9%
    Black or African American
    2
    0.8%
    3
    1.1%
    1
    0.7%
    4
    1.5%
    6
    2.1%
    3
    2.1%
    19
    1.4%
    White
    165
    67.3%
    192
    69.3%
    95
    69.3%
    190
    72.5%
    212
    74.4%
    98
    69%
    952
    70.6%
    Other
    0
    0%
    2
    0.7%
    2
    1.5%
    0
    0%
    0
    0%
    1
    0.7%
    5
    0.4%
    Not Permitted
    0
    0%
    1
    0.4%
    1
    0.7%
    18
    6.9%
    16
    5.6%
    13
    9.2%
    49
    3.6%
    Race/Ethnicity, Customized (Count of Participants)
    Not Hispanic or Latino
    238
    97.1%
    269
    97.1%
    134
    97.8%
    249
    95%
    273
    95.8%
    134
    94.4%
    1297
    96.2%
    Hispanic or Latino
    6
    2.4%
    6
    2.2%
    3
    2.2%
    8
    3.1%
    8
    2.8%
    4
    2.8%
    35
    2.6%
    Not Permitted
    1
    0.4%
    2
    0.7%
    0
    0%
    5
    1.9%
    4
    1.4%
    4
    2.8%
    16
    1.2%
    Region of Enrollment (Count of Participants)
    Poland
    57
    23.3%
    56
    20.2%
    25
    18.2%
    17
    6.5%
    22
    7.7%
    11
    7.7%
    188
    13.9%
    United States
    14
    5.7%
    33
    11.9%
    19
    13.9%
    36
    13.7%
    58
    20.4%
    21
    14.8%
    181
    13.4%
    India
    55
    22.4%
    49
    17.7%
    27
    19.7%
    8
    3.1%
    3
    1.1%
    3
    2.1%
    145
    10.8%
    Japan
    15
    6.1%
    16
    5.8%
    6
    4.4%
    29
    11.1%
    29
    10.2%
    14
    9.9%
    109
    8.1%
    Ukraine
    33
    13.5%
    46
    16.6%
    24
    17.5%
    1
    0.4%
    2
    0.7%
    0
    0%
    106
    7.9%
    France
    1
    0.4%
    1
    0.4%
    1
    0.7%
    32
    12.2%
    26
    9.1%
    19
    13.4%
    80
    5.9%
    Germany
    1
    0.4%
    3
    1.1%
    0
    0%
    31
    11.8%
    26
    9.1%
    9
    6.3%
    70
    5.2%
    Russia
    21
    8.6%
    10
    3.6%
    12
    8.8%
    6
    2.3%
    9
    3.2%
    1
    0.7%
    59
    4.4%
    Italy
    4
    1.6%
    6
    2.2%
    1
    0.7%
    15
    5.7%
    19
    6.7%
    12
    8.5%
    57
    4.2%
    United Kingdom
    7
    2.9%
    3
    1.1%
    0
    0%
    12
    4.6%
    11
    3.9%
    7
    4.9%
    40
    3%
    Belgium
    0
    0%
    0
    0%
    0
    0%
    16
    6.1%
    14
    4.9%
    6
    4.2%
    36
    2.7%
    South Korea
    1
    0.4%
    7
    2.5%
    2
    1.5%
    5
    1.9%
    12
    4.2%
    5
    3.5%
    32
    2.4%
    Australia
    6
    2.4%
    3
    1.1%
    1
    0.7%
    10
    3.8%
    8
    2.8%
    2
    1.4%
    30
    2.2%
    Hungary
    9
    3.7%
    8
    2.9%
    3
    2.2%
    0
    0%
    5
    1.8%
    2
    1.4%
    27
    2%
    Romania
    3
    1.2%
    3
    1.1%
    2
    1.5%
    3
    1.1%
    5
    1.8%
    3
    2.1%
    19
    1.4%
    Switzerland
    0
    0%
    0
    0%
    0
    0%
    7
    2.7%
    5
    1.8%
    7
    4.9%
    19
    1.4%
    Canada
    2
    0.8%
    2
    0.7%
    1
    0.7%
    3
    1.1%
    5
    1.8%
    4
    2.8%
    17
    1.3%
    Czechia
    3
    1.2%
    4
    1.4%
    4
    2.9%
    4
    1.5%
    2
    0.7%
    0
    0%
    17
    1.3%
    Taiwan
    1
    0.4%
    3
    1.1%
    0
    0%
    4
    1.5%
    4
    1.4%
    0
    0%
    12
    0.9%
    Israel
    1
    0.4%
    1
    0.4%
    0
    0%
    5
    1.9%
    4
    1.4%
    0
    0%
    11
    0.8%
    New Zealand
    1
    0.4%
    2
    0.7%
    0
    0%
    4
    1.5%
    2
    0.7%
    1
    0.7%
    10
    0.7%
    South Africa
    0
    0%
    3
    1.1%
    2
    1.5%
    2
    0.8%
    1
    0.4%
    0
    0%
    8
    0.6%
    Spain
    0
    0%
    1
    0.4%
    0
    0%
    1
    0.4%
    4
    1.4%
    2
    1.4%
    8
    0.6%
    Austria
    0
    0%
    0
    0%
    0
    0%
    3
    1.1%
    2
    0.7%
    2
    1.4%
    7
    0.5%
    Croatia
    0
    0%
    1
    0.4%
    0
    0%
    2
    0.8%
    1
    0.4%
    2
    1.4%
    6
    0.4%
    Norway
    0
    0%
    2
    0.7%
    2
    1.5%
    1
    0.4%
    1
    0.4%
    0
    0%
    6
    0.4%
    Sweden
    0
    0%
    0
    0%
    1
    0.7%
    1
    0.4%
    1
    0.4%
    3
    2.1%
    6
    0.4%
    Bulgaria
    1
    0.4%
    3
    1.1%
    1
    0.7%
    0
    0%
    0
    0%
    0
    0%
    5
    0.4%
    Greece
    1
    0.4%
    1
    0.4%
    0
    0%
    0
    0%
    2
    0.7%
    1
    0.7%
    5
    0.4%
    Georgia
    1
    0.4%
    2
    0.7%
    1
    0.7%
    0
    0%
    0
    0%
    0
    0%
    4
    0.3%
    Hong Kong
    2
    0.8%
    1
    0.4%
    0
    0%
    1
    0.4%
    0
    0%
    0
    0%
    4
    0.3%
    Netherlands
    0
    0%
    0
    0%
    0
    0%
    2
    0.8%
    0
    0%
    2
    1.4%
    4
    0.3%
    Serbia
    1
    0.4%
    2
    0.7%
    1
    0.7%
    0
    0%
    0
    0%
    0
    0%
    4
    0.3%
    Slovakia
    2
    0.8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    1.4%
    4
    0.3%
    Argentina
    1
    0.4%
    1
    0.4%
    0
    0%
    1
    0.4%
    0
    0%
    0
    0%
    3
    0.2%
    Malaysia
    0
    0%
    2
    0.7%
    1
    0.7%
    0
    0%
    0
    0%
    0
    0%
    3
    0.2%
    Ireland
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.4%
    1
    0.7%
    2
    0.1%
    Portugal
    0
    0%
    1
    0.4%
    0
    0%
    0
    0%
    1
    0.4%
    0
    0%
    2
    0.1%
    Mexico
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.1%
    Singapore
    0
    0%
    1
    0.4%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.1%

    Outcome Measures

    1. Primary Outcome
    Title Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10
    Description EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
    Time Frame Week 10

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set for the Induction study (Cohorts A and B) included all randomized participants who took at least 1 dose of study drug in the corresponding Induction study.
    Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
    Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
    Measure Participants 245 277 137 262 285 142
    Number (95% Confidence Interval) [percentage of participants]
    26.1
    10.7%
    19.1
    6.9%
    15.3
    11.2%
    11.5
    4.4%
    9.5
    3.3%
    4.2
    3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0157
    Comments
    Method Cochran-Mantel-Haenszel
    Comments Cochran-Mantel-Haenszel(CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and immunomodulators (Yes/No) at Day 1.
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 10.8
    Confidence Interval (2-Sided) 95%
    2.1 to 19.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 100 mg, Induction Study (Cohort A): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3379
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 3.8
    Confidence Interval (2-Sided) 95%
    -4.3 to 12.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 200 mg, Induction Study (Cohort B): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0103
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 7.2
    Confidence Interval (2-Sided) 95%
    1.6 to 12.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 100 mg, Induction Study (Cohort B): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0645
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 5.2
    Confidence Interval (2-Sided) 95%
    -0.0 to 10.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58
    Description EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
    Time Frame Week 58

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set for the Maintenance Study included all participants randomized to either the filgotinib 200 mg or filgotinib 100 mg treatment groups in the Induction Study (Cohorts A and B) who achieved EBS remission or MCS response at Week 10, were rerandomized, and took at least 1 dose of study drug in the Maintenance Study.
    Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Arm/Group Description Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
    Measure Participants 199 98 172 89
    Number (95% Confidence Interval) [percentage of participants]
    37.2
    15.2%
    11.2
    4%
    23.8
    17.4%
    13.5
    5.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Filgotinib 100 mg
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 26.0
    Confidence Interval (2-Sided) 95%
    16.0 to 35.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Placebo, Induction Study (Cohort B): Filgotinib 200 mg
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0420
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 10.4
    Confidence Interval (2-Sided) 95%
    -0.0 to 20.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Induction Study: Percentage of Participants Who Achieved MCS Remission at Week 10
    Description MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
    Time Frame Week 10

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set for the Induction Study (Cohorts A and B) were analyzed.
    Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
    Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
    Measure Participants 245 277 137 262 285 142
    Number (95% Confidence Interval) [percentage of participants]
    24.5
    10%
    17.0
    6.1%
    12.4
    9.1%
    9.5
    3.6%
    6.0
    2.1%
    4.2
    3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0053
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 12.1
    Confidence Interval (2-Sided) 95%
    3.8 to 20.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 100 mg, Induction Study (Cohort A): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2295
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 4.6
    Confidence Interval (2-Sided) 95%
    -3.1 to 12.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 200 mg, Induction Study (Cohort B): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0393
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 5.3
    Confidence Interval (2-Sided) 95%
    -0.1 to 10.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 100 mg, Induction Study (Cohort B): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.5308
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 1.7
    Confidence Interval (2-Sided) 95%
    -3.1 to 6.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10
    Description Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
    Time Frame Week 10

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set for the Induction Study (Cohorts A and B) were analyzed.
    Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
    Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
    Measure Participants 245 277 137 262 285 142
    Number (95% Confidence Interval) [percentage of participants]
    12.2
    5%
    5.8
    2.1%
    3.6
    2.6%
    3.4
    1.3%
    2.1
    0.7%
    2.1
    1.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0047
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 8.6
    Confidence Interval (2-Sided) 95%
    2.9 to 14.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 100 mg, Induction Study (Cohort A): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3495
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 2.1
    Confidence Interval (2-Sided) 95%
    -2.6 to 6.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 200 mg, Induction Study (Cohort B): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.4269
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 1.3
    Confidence Interval (2-Sided) 95%
    -2.5 to 5.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 100 mg, Induction Study (Cohort B): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9987
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -3.4 to 3.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 10
    Description Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of <= 0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).
    Time Frame Week 10

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set for the Induction study (Cohorts A and B) were analyzed.
    Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
    Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
    Measure Participants 245 277 137 262 285 142
    Number (95% Confidence Interval) [percentage of participants]
    35.1
    14.3%
    23.8
    8.6%
    16.1
    11.8%
    19.8
    7.6%
    13.7
    4.8%
    8.5
    6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 19.0
    Confidence Interval (2-Sided) 95%
    9.9 to 28.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 100 mg, Induction Study (Cohort A): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0672
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 7.8
    Confidence Interval (2-Sided) 95%
    -0.7 to 16.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 200 mg, Induction Study (Cohort B): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0019
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 11.4
    Confidence Interval (2-Sided) 95%
    4.2 to 18.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 100 mg, Induction Study (Cohort B): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1286
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 5.2
    Confidence Interval (2-Sided) 95%
    -1.4 to 11.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10
    Description MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
    Time Frame Week 10

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set for the Induction Study (Cohorts A and B) were analyzed.
    Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
    Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
    Measure Participants 245 277 137 262 285 142
    Number (95% Confidence Interval) [percentage of participants]
    12.2
    5%
    8.7
    3.1%
    4.4
    3.2%
    3.8
    1.5%
    2.1
    0.7%
    2.1
    1.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0105
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 7.9
    Confidence Interval (2-Sided) 95%
    1.9 to 13.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 100 mg, Induction Study (Cohort A): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1062
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 4.3
    Confidence Interval (2-Sided) 95%
    -1.0 to 9.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 200 mg, Induction Study (Cohort B): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.3084
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 1.7
    Confidence Interval (2-Sided) 95%
    -2.2 to 5.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 100 mg, Induction Study (Cohort B): Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.9109
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value -0.0
    Confidence Interval (2-Sided) 95%
    -3.4 to 3.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845
    Description Cmax is defined as the maximum observed concentration of drug.
    Time Frame Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10

    Outcome Measure Data

    Analysis Population Description
    PK Substudy Analysis Set included all randomized participants who took at least 1 dose of filgotinib, participated in the PK substudy, and had at least 1 nonmissing intensive concentration value for filgotinib and/or GS-829845 with available data were analyzed.
    Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg
    Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
    Measure Participants 4 11 9 17
    Filgotinib
    1746.3
    (1244.05)
    725.1
    (313.36)
    2283.3
    (1012.03)
    977.9
    (403.51)
    Metabolite GS-829845
    3227.5
    (1204.50)
    1812.2
    (701.46)
    4373.3
    (1121.58)
    2002.9
    (598.73)
    8. Secondary Outcome
    Title Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845
    Description Tmax is defined as the time to reach maximum observed concentration of drug.
    Time Frame Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10

    Outcome Measure Data

    Analysis Population Description
    Participants in the PK Substudy Analysis Set with available data were analyzed.
    Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg
    Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
    Measure Participants 4 11 9 17
    Filgotinib
    1.50
    0.75
    1.00
    0.57
    Metabolite GS-829845
    3.76
    3.00
    3.02
    3.00
    9. Secondary Outcome
    Title Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984
    Description AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
    Time Frame Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10

    Outcome Measure Data

    Analysis Population Description
    Participants in the PK Substudy Analysis Set with available data were analyzed.
    Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg
    Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
    Measure Participants 4 11 9 17
    Filgotinib
    5501.3
    (1956.39)
    1909.3
    (788.13)
    6475.6
    (1643.00)
    2492.3
    (852.52)
    Metabolite GS-829845
    57982.0
    (17767.52)
    31187.9
    (11858.78)
    80208.6
    (25096.57)
    36075.6
    (13396.86)
    10. Secondary Outcome
    Title Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984
    Description AUClast is defined as the concentration of drug from time zero to the last observable concentration.
    Time Frame Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10

    Outcome Measure Data

    Analysis Population Description
    Participants in the PK Substudy Analysis Set with available data were analyzed.
    Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg
    Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
    Measure Participants 4 11 9 17
    Filgotinib
    5537.3
    (1900.93)
    1881.9
    (797.51)
    6743.1
    (1743.68)
    2420.3
    (837.26)
    Metabolite GS-829845
    60938.4
    (6961.77)
    30643.2
    (12935.37)
    79286.3
    (27968.49)
    34385.6
    (15160.15)
    11. Secondary Outcome
    Title Induction Study: PK Parameter: Ctau of Filgotinib and Its Metabolite GS-82984
    Description Ctau is defined as the observed drug concentration at the end of the dosing interval.
    Time Frame Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10

    Outcome Measure Data

    Analysis Population Description
    Participants in the PK Substudy Analysis Set with available data were analyzed.
    Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg
    Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
    Measure Participants 4 11 9 17
    Filgotinib
    12.0
    (4.74)
    4.5
    (3.61)
    36.6
    (79.06)
    4.1
    (3.05)
    Metabolite GS-829845
    2050.0
    (493.66)
    934.8
    (372.68)
    2581.3
    (777.07)
    1062.8
    (463.67)
    12. Secondary Outcome
    Title Maintenance Study: Percentage of Participants Who Achieved MCS Remission at Week 58
    Description MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA. The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
    Time Frame Week 58

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set for the Maintenance Study were analyzed.
    Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Arm/Group Description Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm) who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
    Measure Participants 199 98 172 89
    Number (95% Confidence Interval) [percentage of participants]
    34.7
    14.2%
    9.2
    3.3%
    22.7
    16.6%
    13.5
    5.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Filgotinib 100 mg
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 25.5
    Confidence Interval (2-Sided) 95%
    16.0 to 35.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Placebo, Induction Study (Cohort B): Filgotinib 200 mg
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0658
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 9.2
    Confidence Interval (2-Sided) 95%
    -1.1 to 19.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Secondary Outcome
    Title Maintenance Study: Percentage of Participants Who Achieved Sustained EBS Remission at Week 58
    Description Sustained EBS remission was defined as having achieved EBS remission at both Weeks 10 and 58.
    Time Frame Week 58

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set for the Maintenance Study were analyzed.
    Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Arm/Group Description Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
    Measure Participants 199 98 172 89
    Number (95% Confidence Interval) [percentage of participants]
    18.1
    7.4%
    5.1
    1.8%
    8.7
    6.4%
    7.9
    3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Filgotinib 100 mg
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0024
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 13.0
    Confidence Interval (2-Sided) 95%
    5.3 to 20.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Placebo, Induction Study (Cohort B): Filgotinib 200 mg
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.7951
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 0.9
    Confidence Interval (2-Sided) 95%
    -7.0 to 8.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    14. Secondary Outcome
    Title Maintenance Study: Percentage of Participants Who Achieved 6-Month Corticosteroid-Free EBS Remission at Week 58
    Description Six-month corticosteroid-free EBS remission at Week 58 was defined as achieving EBS remission with no corticosteroid use for the indication of ulcerative colitis for at least 6 months prior to Week 58.
    Time Frame Week 58

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set who were on corticosteroids at Maintenance Study baseline were analyzed.
    Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Arm/Group Description Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
    Measure Participants 92 47 81 37
    Number (95% Confidence Interval) [percentage of participants]
    27.2
    11.1%
    6.4
    2.3%
    13.6
    9.9%
    5.4
    2.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Filgotinib 100 mg
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0055
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 20.8
    Confidence Interval (2-Sided) 95%
    7.7 to 33.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Placebo, Induction Study (Cohort B): Filgotinib 200 mg
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1265
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 8.2
    Confidence Interval (2-Sided) 95%
    -4.2 to 20.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    15. Secondary Outcome
    Title Maintenance Study: Percentage of Participants Who Achieved Endoscopic Subscore of 0 at Weeks 58
    Description Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
    Time Frame Week 58

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set for the Maintenance Study were analyzed.
    Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Arm/Group Description Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
    Measure Participants 199 98 172 89
    Number (95% Confidence Interval) [percentage of participants]
    15.6
    6.4%
    6.1
    2.2%
    13.4
    9.8%
    7.9
    3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Filgotinib 100 mg
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0157
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 9.5
    Confidence Interval (2-Sided) 95%
    1.8 to 17.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Placebo, Induction Study (Cohort B): Filgotinib 200 mg
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.1808
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 5.5
    Confidence Interval (2-Sided) 95%
    -2.9 to 13.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Secondary Outcome
    Title Maintenance Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 58
    Description Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of <= 0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).
    Time Frame Week 58

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set for the Maintenance Study were analyzed.
    Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Arm/Group Description Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
    Measure Participants 199 98 172 89
    Number (95% Confidence Interval) [percentage of participants]
    38.2
    15.6%
    13.3
    4.8%
    27.9
    20.4%
    18.0
    6.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Filgotinib 100 mg
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 24.9
    Confidence Interval (2-Sided) 95%
    14.6 to 35.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Placebo, Induction Study (Cohort B): Filgotinib 200 mg
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0521
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 9.9
    Confidence Interval (2-Sided) 95%
    -1.3 to 21.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    17. Secondary Outcome
    Title Maintenance Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 58
    Description MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
    Time Frame Week 58

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set for the Maintenance Study were analyzed.
    Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Arm/Group Description Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
    Measure Participants 199 98 172 89
    Number (95% Confidence Interval) [percentage of participants]
    22.1
    9%
    6.1
    2.2%
    12.2
    8.9%
    7.9
    3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Filgotinib 100 mg
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 16.0
    Confidence Interval (2-Sided) 95%
    7.8 to 24.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Placebo, Induction Study (Cohort B): Filgotinib 200 mg
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.2946
    Comments
    Method Cochran-Mantel-Haenszel
    Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value 4.3
    Confidence Interval (2-Sided) 95%
    -3.9 to 12.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    18. Secondary Outcome
    Title Maintenance Study: Plasma Concentration of Filgotinib and Its Metabolite GS-829845
    Description Plasma concentration is defined as the measured drug concentration of filgotinib and its metabolite GS-829845. Lower limit of quantitation (LLOQ) was defined as 1 ng/mL for analyte filgotinib and 2 ng/mL for analyte GS-829845.
    Time Frame Week 26 (any Time) and Week 58 (predose)

    Outcome Measure Data

    Analysis Population Description
    PK Analysis Set included all participants in the Safety Analysis Set who who took at least 1 dose of filgotinib and had at least 1 nonmissing plasma concentration value for filgotinib and/or its metabolite GS-829845 with available data were analyzed. Data was not collected for the Maintenance Study Placebo arms.
    Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
    Arm/Group Description Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
    Measure Participants 173 136
    Filgotinib: Week 26
    8.5
    4.4
    Filgotinib: Week 58
    3.9
    4.1
    Metabolite GS-829845: Week 26
    2495.0
    1180.0
    Metabolite GS-829845: Week 58
    1930.0
    973.5

    Adverse Events

    Time Frame Induction Study: first dose date up to one day before the Maintenance first dose date or last dose date whichever is earlier (maximum 17 weeks) plus 30 days, Maintenance study: First dose to the last dose in the Maintenance Study (maximum 51 weeks) plus 30 days
    Adverse Event Reporting Description Adverse Events: Safety Analysis Set for the study included all participants who took at least 1 dose of study drug in either the Induction Study (Cohorts A and B) or the Maintenance Study. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized on Day 1 into each corresponding study.
    Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Placebo
    Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
    All Cause Mortality
    Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/245 (0%) 0/278 (0%) 0/137 (0%) 0/262 (0%) 0/286 (0%) 0/143 (0%) 2/202 (1%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Serious Adverse Events
    Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/245 (1.2%) 13/277 (4.7%) 4/137 (2.9%) 19/262 (7.3%) 15/285 (5.3%) 9/142 (6.3%) 9/202 (4.5%) 0/99 (0%) 8/179 (4.5%) 7/91 (7.7%) 4/93 (4.3%)
    Blood and lymphatic system disorders
    Anaemia 0/245 (0%) 1/277 (0.4%) 1/137 (0.7%) 1/262 (0.4%) 1/285 (0.4%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Iron deficiency anaemia 0/245 (0%) 1/277 (0.4%) 0/137 (0%) 1/262 (0.4%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 1/91 (1.1%) 0/93 (0%)
    Pancytopenia 0/245 (0%) 1/277 (0.4%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Cardiac disorders
    Coronary artery stenosis 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 1/91 (1.1%) 0/93 (0%)
    Left ventricular failure 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 1/202 (0.5%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Pericarditis 1/245 (0.4%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Gastrointestinal disorders
    Abdominal pain 0/245 (0%) 0/277 (0%) 0/137 (0%) 1/262 (0.4%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 1/179 (0.6%) 0/91 (0%) 0/93 (0%)
    Anal fissure 0/245 (0%) 0/277 (0%) 0/137 (0%) 1/262 (0.4%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Appendiceal mucocoele 0/245 (0%) 0/277 (0%) 0/137 (0%) 1/262 (0.4%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Colitis ulcerative 0/245 (0%) 3/277 (1.1%) 3/137 (2.2%) 7/262 (2.7%) 5/285 (1.8%) 5/142 (3.5%) 0/202 (0%) 0/99 (0%) 1/179 (0.6%) 1/91 (1.1%) 0/93 (0%)
    Dental cyst 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 1/93 (1.1%)
    Duodenal ulcer haemorrhage 0/245 (0%) 0/277 (0%) 0/137 (0%) 1/262 (0.4%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Gastritis 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 1/285 (0.4%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Gastrointestinal haemorrhage 1/245 (0.4%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Large intestinal haemorrhage 0/245 (0%) 0/277 (0%) 0/137 (0%) 1/262 (0.4%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Nausea 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 1/285 (0.4%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Pancreatitis acute 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 1/142 (0.7%) 0/202 (0%) 0/99 (0%) 1/179 (0.6%) 0/91 (0%) 0/93 (0%)
    Supernumerary teeth 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 1/93 (1.1%)
    Vomiting 0/245 (0%) 1/277 (0.4%) 0/137 (0%) 0/262 (0%) 1/285 (0.4%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    General disorders
    Chest pain 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 1/285 (0.4%) 0/142 (0%) 1/202 (0.5%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Non-cardiac chest pain 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 1/179 (0.6%) 0/91 (0%) 0/93 (0%)
    Pyrexia 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 1/202 (0.5%) 0/99 (0%) 1/179 (0.6%) 0/91 (0%) 0/93 (0%)
    Hepatobiliary disorders
    Autoimmune hepatitis 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 1/91 (1.1%) 0/93 (0%)
    Cholelithiasis 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 1/179 (0.6%) 0/91 (0%) 0/93 (0%)
    Immune system disorders
    Type I hypersensitivity 0/245 (0%) 1/277 (0.4%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Infections and infestations
    Acute hepatitis B 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 1/91 (1.1%) 0/93 (0%)
    Anal abscess 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 1/285 (0.4%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Appendicitis 0/245 (0%) 1/277 (0.4%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 1/202 (0.5%) 0/99 (0%) 2/179 (1.1%) 0/91 (0%) 0/93 (0%)
    Campylobacter gastroenteritis 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 1/142 (0.7%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Cellulitis 0/245 (0%) 0/277 (0%) 1/137 (0.7%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 1/179 (0.6%) 0/91 (0%) 0/93 (0%)
    Clostridium difficile infection 0/245 (0%) 0/277 (0%) 0/137 (0%) 1/262 (0.4%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Dengue fever 1/245 (0.4%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Diverticulitis 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 1/202 (0.5%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Gastroenteritis 0/245 (0%) 1/277 (0.4%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Gastroenteritis viral 0/245 (0%) 0/277 (0%) 0/137 (0%) 1/262 (0.4%) 0/285 (0%) 1/142 (0.7%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 1/91 (1.1%) 0/93 (0%)
    Osteomyelitis 0/245 (0%) 0/277 (0%) 1/137 (0.7%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Paronychia 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 1/179 (0.6%) 0/91 (0%) 0/93 (0%)
    Pneumonia 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 1/93 (1.1%)
    Sepsis 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 2/285 (0.7%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Staphylococcal infection 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 1/285 (0.4%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Injury, poisoning and procedural complications
    Femur fracture 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 1/285 (0.4%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Meniscus injury 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 1/91 (1.1%) 0/93 (0%)
    Procedural intestinal perforation 0/245 (0%) 0/277 (0%) 1/137 (0.7%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Road traffic accident 0/245 (0%) 1/277 (0.4%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Tendon rupture 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 1/202 (0.5%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion 0/245 (0%) 0/277 (0%) 0/137 (0%) 2/262 (0.8%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Myalgia 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 1/285 (0.4%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer 0/245 (0%) 0/277 (0%) 0/137 (0%) 1/262 (0.4%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Colon cancer 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 1/179 (0.6%) 0/91 (0%) 0/93 (0%)
    Malignant melanoma 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 1/202 (0.5%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Nervous system disorders
    Cerebrovascular accident 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 1/142 (0.7%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Headache 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 1/285 (0.4%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Transient ischaemic attack 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 1/179 (0.6%) 0/91 (0%) 0/93 (0%)
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 1/285 (0.4%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Renal and urinary disorders
    Acute kidney injury 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 1/93 (1.1%)
    Calculus urinary 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 1/202 (0.5%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Nephrolithiasis 0/245 (0%) 0/277 (0%) 0/137 (0%) 1/262 (0.4%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Renal colic 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 1/142 (0.7%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Reproductive system and breast disorders
    Ovarian cyst ruptured 0/245 (0%) 1/277 (0.4%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 1/202 (0.5%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Atelectasis 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 1/179 (0.6%) 0/91 (0%) 0/93 (0%)
    Dyspnoea 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 1/179 (0.6%) 0/91 (0%) 0/93 (0%)
    Haemoptysis 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 1/142 (0.7%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Pulmonary embolism 0/245 (0%) 0/277 (0%) 0/137 (0%) 1/262 (0.4%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Pulmonary mass 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 1/179 (0.6%) 0/91 (0%) 0/93 (0%)
    Vascular disorders
    Deep vein thrombosis 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 1/93 (1.1%)
    Haemorrhagic infarction 0/245 (0%) 0/277 (0%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 1/93 (1.1%)
    Hypertension 0/245 (0%) 1/277 (0.4%) 0/137 (0%) 0/262 (0%) 0/285 (0%) 0/142 (0%) 0/202 (0%) 0/99 (0%) 0/179 (0%) 0/91 (0%) 0/93 (0%)
    Other (Not Including Serious) Adverse Events
    Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 40/245 (16.3%) 43/277 (15.5%) 20/137 (14.6%) 83/262 (31.7%) 77/285 (27%) 55/142 (38.7%) 67/202 (33.2%) 33/99 (33.3%) 53/179 (29.6%) 33/91 (36.3%) 26/93 (28%)
    Blood and lymphatic system disorders
    Anaemia 6/245 (2.4%) 10/277 (3.6%) 4/137 (2.9%) 12/262 (4.6%) 11/285 (3.9%) 10/142 (7%) 4/202 (2%) 0/99 (0%) 4/179 (2.2%) 1/91 (1.1%) 0/93 (0%)
    Gastrointestinal disorders
    Abdominal pain 3/245 (1.2%) 3/277 (1.1%) 3/137 (2.2%) 8/262 (3.1%) 7/285 (2.5%) 9/142 (6.3%) 8/202 (4%) 6/99 (6.1%) 6/179 (3.4%) 2/91 (2.2%) 4/93 (4.3%)
    Colitis ulcerative 6/245 (2.4%) 3/277 (1.1%) 5/137 (3.6%) 14/262 (5.3%) 11/285 (3.9%) 6/142 (4.2%) 21/202 (10.4%) 18/99 (18.2%) 18/179 (10.1%) 16/91 (17.6%) 10/93 (10.8%)
    Nausea 8/245 (3.3%) 3/277 (1.1%) 1/137 (0.7%) 7/262 (2.7%) 15/285 (5.3%) 6/142 (4.2%) 5/202 (2.5%) 1/99 (1%) 4/179 (2.2%) 0/91 (0%) 2/93 (2.2%)
    General disorders
    Pyrexia 5/245 (2%) 1/277 (0.4%) 1/137 (0.7%) 6/262 (2.3%) 3/285 (1.1%) 8/142 (5.6%) 6/202 (3%) 1/99 (1%) 4/179 (2.2%) 3/91 (3.3%) 1/93 (1.1%)
    Infections and infestations
    Nasopharyngitis 7/245 (2.9%) 9/277 (3.2%) 2/137 (1.5%) 20/262 (7.6%) 20/285 (7%) 11/142 (7.7%) 22/202 (10.9%) 6/99 (6.1%) 12/179 (6.7%) 6/91 (6.6%) 5/93 (5.4%)
    Upper respiratory tract infection 2/245 (0.8%) 2/277 (0.7%) 0/137 (0%) 13/262 (5%) 4/285 (1.4%) 5/142 (3.5%) 11/202 (5.4%) 3/99 (3%) 6/179 (3.4%) 3/91 (3.3%) 3/93 (3.2%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/245 (0%) 4/277 (1.4%) 2/137 (1.5%) 8/262 (3.1%) 10/285 (3.5%) 7/142 (4.9%) 8/202 (4%) 7/99 (7.1%) 6/179 (3.4%) 3/91 (3.3%) 4/93 (4.3%)
    Nervous system disorders
    Headache 11/245 (4.5%) 12/277 (4.3%) 6/137 (4.4%) 19/262 (7.3%) 10/285 (3.5%) 9/142 (6.3%) 7/202 (3.5%) 0/99 (0%) 10/179 (5.6%) 5/91 (5.5%) 5/93 (5.4%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years

    Results Point of Contact

    Name/Title Gilead Clinical Study Information Center
    Organization Gilead Sciences
    Phone 1-833-445-3230 (GILEAD-0)
    Email GileadClinicalTrials@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02914522
    Other Study ID Numbers:
    • GS-US-418-3898
    • 2016-001392-78
    First Posted:
    Sep 26, 2016
    Last Update Posted:
    Apr 21, 2021
    Last Verified:
    Mar 1, 2021