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A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease

Sponsor
AbbVie (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02782663
Collaborator
(none)
210
Enrollment
61
Locations
2
Arms
112
Anticipated Duration (Months)
3.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease
Actual Study Start Date :
May 18, 2016
Anticipated Primary Completion Date :
Sep 17, 2025
Anticipated Study Completion Date :
Sep 17, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Upadacitinib (ABT-494) Dose A

Open label dose A once daily (QD)

Drug: ABT-494
Tablet: Oral
Other Names:
  • Upadacitinib
  • RINVOQ

    		•
    Experimental: Upadacitinib (ABT-494) Dose B

    Open label dose B QD

    Drug: ABT-494
    Tablet: Oral
    Other Names:
  • Upadacitinib
  • RINVOQ

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving Remission [Up to Month 96]

      It is defined as the percentage of participants achieving clinical remission and endoscopic remission.

    2. Percentage of Participants in Remission at Week 0 Who Maintain Remission [Up to Month 96]

      Remission is defined as participants achieving clinical remission and endoscopic remission.

    3. Percentage of Participants Achieving Response [Up to Month 96]

      It is defined as the percentage of participants achieving clinical response and endoscopic response.

    4. Percentage of Participants Achieving Clinical Remission [Up to Month 96]

      Clinical remission is defined based on the patient reported outcomes: average daily stool frequency and average daily abdominal pain.

    5. Percentage of Participants Achieving Modified Clinical Remission [Up to Month 96]

      Clinical remission is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.

    6. Percentage of Participants Achieving Enhanced Clinical Response [Up to Month 96]

      Enhanced clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.

    7. Percentage of Participants Achieving Clinical Response [Up to Month 96]

      Clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.

    8. Percentage of Participants Achieving Endoscopic Remission [Up to Month 96]

      Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.

    9. Percentage of Participants in Endoscopic Remission at Week 0 Who Maintain Endoscopic Remission [Up to Month 96]

      Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.

    10. Percentage of Participants Achieving Endoscopic Improvement [Up to Month 96]

      Endoscopic improvement is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease or endoscopic remission.

    11. Percentage of Participants Achieving Endoscopic Response [Up to Month 96]

      Endoscopic response is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease.

    12. Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission [Up to Month 96]

      It is defined as CDAI less than 150.

    13. Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Response [Up to Month 96]

      CDAI response is defined as a reduction in CDAI by >= 70 from baseline of Study M13-740.

    14. Percentage of Participants Achieving Enhanced CDAI Response [Up to Month 96]

      Enhanced CDAI response is defined as reduction in CDAI by >= 100 from baseline of Study M13-740.

    15. Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission [Up to Month 96]

      IBDQ remission is defined as IBDQ >= 170.

    16. Percentage of Participants Achieving IBDQ Response [Up to Month 96]

      IBDQ response is defined as an increase in IBDQ score >= 16 point from Baseline of Study M13-740.

    17. Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free [Up to Month 96]

      Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free

    18. Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission [Up to Month 96]

      Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free for at least 90 days over time and achieve Remission

    19. Percentage of Participants Achieving Remission and Normal C-Reactive Protein [Up to Month 96]

      Percentage of participants achieving Remission and normal C-reactive protein. Remission is defined as Clinical Remission AND Endoscopic Remission.

    Eligibility Criteria

    Criteria

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

    • Participant must have completed Study M13-740 through Week 52.

    • If female, participant must be postmenopausal, surgically sterile or on using a birth control method.

    Exclusion Criteria:

    • For any reason participant is considered by the investigator to be an unsuitable candidate

    • Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.

    • Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC San Diego Health System /ID# 150041 La Jolla California United States 92093
    2 Univ California, San Francisco /ID# 149987 San Francisco California United States 94143-2204
    3 University of Florida - Archer /ID# 150033 Gainesville Florida United States 32610
    4 The Ctr for Gastro Disorders /ID# 150012 Hollywood Florida United States 33021
    5 Nature Coast Clinical Research - Inverness /ID# 149975 Inverness Florida United States 34452-4717
    6 Gastroenterology Associates of Central Georgia, LLC /ID# 149870 Macon Georgia United States 31201
    7 GI Specialists of GA, PC /ID# 150015 Marietta Georgia United States 30060
    8 Cotton-O'Neil Clinical Res Ctr /ID# 149900 Topeka Kansas United States 66606
    9 University of Louisville /ID# 149884 Louisville Kentucky United States 40202
    10 Investigative Clinical Research /ID# 149886 Annapolis Maryland United States 21401
    11 Charm City Research Group /ID# 150040 Towson Maryland United States 21204
    12 Center for Digestive Health /ID# 150008 Troy Michigan United States 48098-6363
    13 Mayo Clinic - Rochester /ID# 149894 Rochester Minnesota United States 55905-0001
    14 Kansas City Research Institute /ID# 149888 Kansas City Missouri United States 64131
    15 Washington University-School of Medicine /ID# 149899 Saint Louis Missouri United States 63110
    16 NYU Langone Long Island Clinical Research Associates /ID# 149976 Lake Success New York United States 11042
    17 Weill Cornell Medicine/NYP /ID# 149895 New York New York United States 10021-4872
    18 Univ NC Chapel Hill /ID# 149982 Chapel Hill North Carolina United States 27514-4220
    19 University of Cincinnati /ID# 149977 Cincinnati Ohio United States 45267-0585
    20 Options Health Research, LLC /ID# 150010 Tulsa Oklahoma United States 74104
    21 Texas Digestive Disease Consultants - Southlake /ID# 149869 Southlake Texas United States 76092
    22 Texas Digestive Disease Consultants - Southlake /ID# 149989 Southlake Texas United States 76092
    23 Aspen Clinical Research /ID# 150020 Orem Utah United States 84058
    24 University of Virginia /ID# 149881 Charlottesville Virginia United States 22908
    25 Virginia Mason Medical Center /ID# 150042 Seattle Washington United States 98101
    26 University of Washington /ID# 149988 Seattle Washington United States 98109
    27 Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 149863 Milwaukee Wisconsin United States 53215
    28 CHU de Liege /ID# 149912 Liege Belgium 4000
    29 University of Alberta - Zeidler Ledcor Centre /ID# 149873 Edmonton Alberta Canada T6G 2X8
    30 University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 149876 Vancouver British Columbia Canada V5Z 3N9
    31 GIRI Gastrointestinal Research Institute /ID# 149878 Vancouver British Columbia Canada V6Z 2K5
    32 Toronto Digestive Disease Asso /ID# 149877 Vaughan Ontario Canada L4L 4Y7
    33 Royal Victoria Hospital / McGill University Health Centre /ID# 149871 Montreal Quebec Canada H4A 3J1
    34 Hepato-Gastroenterologie HK, s.r.o. /ID# 149882 Hradec Kralove Czechia 500 12
    35 Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 149890 Hvidovre Hovedstaden Denmark 2650
    36 Aarhus University Hospital /ID# 149919 Aarhus N Midtjylland Denmark 8200
    37 CHRU Lille - Hopital Claude Huriez /ID# 149897 Lille Hauts-de-France France 59037
    38 CHRU Nancy - Hôpitaux de Brabois /ID# 149896 Vandœuvre-lès-Nancy Meurthe-et-Moselle France 54500
    39 CHU Amiens-Picardie Site Sud /ID# 149921 Amiens CEDEX 1 Somme France 80054
    40 Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 149936 Kiel Schleswig-Holstein Germany 24105
    41 DRK Kliniken Berlin Westend /ID# 149905 Berlin Germany 14050
    42 Medizinisches Versorgungszentrum Portal 10 /ID# 149930 Muenster Germany 48155
    43 Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907 Budapest Hungary 1124
    44 The Chaim Sheba Medical Center /ID# 149945 Ramat Gan Tel-Aviv Israel 5265601
    45 Assaf Harofeh Medical Center /ID# 149943 Be'Er Ya'Akov Israel 70300
    46 Rabin Medical Center /ID# 149942 Petakh Tikva Israel 4941492
    47 University of Catanzaro /ID# 149927 Catanzaro Calabria Italy 88100
    48 A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 149958 Bologna Italy 40138
    49 Academisch Medisch Centrum /ID# 149932 Amsterdam Netherlands 1105 AZ
    50 Universitair Medisch Centrum Utrecht /ID# 149933 Utrecht Netherlands 3584 CX
    51 Dunedin Hospital /ID# 149964 Otago New Zealand 9016
    52 Lovisenberg Diakonale Sykehus /ID# 149967 Oslo Norway 0440
    53 Centrum Medyczne Szpital Swietej Rodziny /ID# 149979 Lodz Lodzkie Poland 90-302
    54 Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 149978 Warszawa Mazowieckie Poland 02-507
    55 Cabinet Particular Policlinic Algomed /ID# 149993 Timișoara Romania 300002
    56 KM Management, spol. s.r.o. /ID# 149949 Nitra Slovakia 949 01
    57 GASTRO I., s.r.o. /ID# 149948 Presov Slovakia 080 01
    58 Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 149996 Ferrol A Coruna Spain 15405
    59 Hospital Universitario La Paz /ID# 149997 Madrid Spain 28046
    60 Oxford University Hospitals NHS Foundation Trust /ID# 149963 Oxford Oxfordshire United Kingdom OX3 9DU
    61 Manchester University NHS Foundation Trust /ID# 150006 Manchester United Kingdom M13 9WL

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT02782663
    Other Study ID Numbers:
    • M14-327
    • 2015-003759-23
    First Posted:
    May 25, 2016
    Last Update Posted:
    Dec 7, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Crohn's Disease
    Efficacy
    Safety
    Tolerability
    ABT-494
    Additional relevant MeSH terms:
    Crohn Disease
    Upadacitinib

    Study Results

    No Results Posted as of Dec 7, 2021