Clincosm LogoSign in Get a demo

PROGRESS: A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05784129
Collaborator
(none)
370
Enrollment
135
Locations
2
Arms
51.7
Anticipated Duration (Months)
2.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness of guselkumab treatment compared with placebo (an inactive substance with no medicine) in preventing recurrence of Crohn's disease in participants after surgery.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
370 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
Actual Study Start Date :
Feb 21, 2023
Anticipated Primary Completion Date :
Apr 18, 2025
Anticipated Study Completion Date :
Jun 15, 2027

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1: Guselkumab

Participants will receive Guselkumab Dose 1 subcutaneously (SC) followed by Dose 2 SC thereafter through Week 144. Participants with disease recurrence will receive guselkumab SC treatment.

Drug: Guselkumab
Guselkumab will be administered subcutaneously.
Other Names:
  • CNTO1959

    		•
    Placebo Comparator: Group 2: Placebo

    Participants will receive matching placebo injections subcutaneously. Participants with disease recurrence will receive guselkumab SC treatment.

    Drug: Placebo
    Placebo will be administered subcutaneously.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with Endoscopic Recurrence Prior to or at Week 48 [Up to Week 48]

      Endoscopic recurrence is defined by modified Rutgeerts score greater than or equal to (>=) i2a in the neo-terminal ileum, anastomotic site, or its equivalent elsewhere in the gastrointestinal (GI) tract.

    Secondary Outcome Measures

    1. Clinical Remission Without Disease Recurrence at Week 48 [At Week 48]

      Clinical remission without disease recurrence is defined by the following: Crohn's Disease Activity Index (CDAI) less than (<)150 at Week 48 and No endoscopic recurrence. Have not experienced a disease recurrence. The CDAI score will be assessed by collecting information on 8 different Crohn's disease-related variables, with scores ranging from 0 to approximately 600. A decrease over time indicates improvement in disease activity.

    2. Time-to-Disease Recurrence [Up to Week 48]

      Disease recurrence is defined as one of the following: (1) >= 70-point increase from baseline in CDAI score at beyond 8 weeks after randomization; and a CDAI score of >= 200 and evidence of endoscopic recurrence; (2) Initiation of a physician-prescribed corticosteroids, or an increase in the dose of steroids already being taken (by greater than 5 milligrams per day [mg/day]), for over one week for the treatment of Crohn's disease (CD) and evidence of endoscopic recurrence as described above; (3) A new draining external fistula; (4) The reopening and draining of a previously existing external fistula; (5) Developing a new internal fistula; (6) Developing a new perianal abscess; (7) Or developing a new intra abdominal abscess more than three months after the date of the index surgery.

    3. Number of Participants with No Abdominal Pain At Week 48 [At Week 48]

      Number of patients with an abdominal pain score of 0 at Week 48 will be reported.

    4. Time To Recurrence of Symptoms [Up to Week 48]

      Time to recurrence of symptoms, defined as time to attaining an abdominal pain mean daily score greater than (>) 1 (and also >1 point higher than baseline) along with stool frequency (SF) mean daily score >3 (and also >3 higher per day than baseline) for 2 consecutive weeks through Week 48.

    5. Number of Participants with Adverse Events (AEs) [156 Weeks]

      An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    6. Number of Participants with Serious Adverse Events (SAEs) [156 weeks]

      A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    7. Serum Guselkumab Concentrations Over Time [At Week 0, 8, 16, 24, 32, 48, 96, 128, and 152]

      Serum guselkumab concentrations over time will be assessed.

    8. Steroid Free Clinical Remission at Week 48 [At Week 48]

      Steroid free clinical remission at Week 48, defined as CDAI < 150 and no corticosteroids within 30 days. The CDAI score will be assessed by collecting information on 8 different Crohn's disease-related variables, with scores ranging from 0 to approximately 600. A decrease over time indicates improvement in disease activity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have a documented diagnosis of Crohn's disease (CD) confirmed by endoscopic, histologic, and/or radiologic studies prior to resection or by tissue obtained at resection

    • Have undergone an ileocolonic surgical resection (that is, an intestinal resection with an ileocolonic anastomosis) for CD prior to the baseline visit with the following criteria: (a)Have no known active CD anywhere in the gastrointestinal (GI) tract, including the findings at surgery. (b)Be able to undergo randomization no later than 49 days after surgery, and at least 10 days after surgery (or 8 days after resumption of bowel activity, example, in case of postoperative ileus) (c) Ileocolonic resection was not for the purpose of removing known dysplasia. (d) If ileocolonic resection occurs greater than (>) 10 years since the diagnosis of CD and only fibrostenotic stricturing is present, then length of stricture must be > 10 centimeter (cm)

    • Have a baseline Crohn's Disease Activity Index (CDAI) less than (<) 200

    • A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) test result during screening and a negative urine pregnancy test at week 0, prior to randomization

    • A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 12 weeks after the last administration of study intervention

    Exclusion Criteria:

    • Has complications of CD, such as symptomatic strictures or stenoses, short bowel syndrome, a draining (that is, functioning) stoma or ostomy, or any other manifestation, that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab

    • Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery

    • Have had any active perianal disease within 3 months of screening (except skin tags) or have had any draining fistula within 3 months of screening unless the fistula was removed at the index surgery

    • Evidence of a herpes zoster infection within 8 weeks before the first dose of study intervention

    • Has a history of severe, progressive, or uncontrolled renal, genitourinary, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Associates Research Group, Inc. San Diego California United States 92123
    2 University of California, San Francisco San Francisco California United States 94115
    3 University of Colorado Denver Anschultz Medical Campus Aurora Colorado United States 80045
    4 Medical Research Center of Connecticut Hamden Connecticut United States 06518
    5 Gastroenterology Group Of Naples Naples Florida United States 34102
    6 Gastroenterolgy Associates of Central GA Macon Georgia United States 31201
    7 University of Louisville Louisville Kentucky United States 40202
    8 Digestive Health Center of Louisiana Baton Rouge Louisiana United States 70809
    9 Louisiana Research Center, LLC Shreveport Louisiana United States 71105
    10 Chevy Chase Clinical Research Chevy Chase Maryland United States 20815
    11 Brigham & Women's Hospital Chestnut Hill Massachusetts United States 02467
    12 University of Michigan Health Systems Ann Arbor Michigan United States 48109
    13 Huron Gastroenterology Associates Center for Digestive Care Ypsilanti Michigan United States 48197
    14 NYU Langone Medical Center New Hyde Park New York United States 11042
    15 Rush University Medical Center New York New York United States 60612
    16 Smart Medical Research Queens Village New York United States 11427
    17 Asheville Gastroenterology Associates Asheville North Carolina United States 28801
    18 The University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599
    19 Greater Cincinnati Gastroenterology Association, Inc. Cincinnati Ohio United States 45219
    20 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    21 Cleveland Clinic Cleveland Ohio United States 44195
    22 University of Miami/Sylvester Cancer Center Philadelphia Pennsylvania United States 19104
    23 Medical University of South Carolina Charleston South Carolina United States 29425
    24 Texas Digestive Consultants of South Texas dba Texas Digestive Specialists Brownsville Texas United States 78526
    25 Baylor University Medical Center Dallas Texas United States 75246
    26 Baylor College of Medicine Houston Texas United States 77030
    27 Gastroenterology Research of San Antonio San Antonio Texas United States 78212
    28 Center For Digestive Disease Shenandoah Texas United States 77384
    29 Texas Digestive Disease Consultants Southlake Texas United States 76092
    30 Texas Gastroenterology Associates - Research Spring Texas United States 77386
    31 Tyler Research Institute, LLC Tyler Texas United States 75701
    32 Velocity Clinical Research Riverton Utah United States 84065
    33 Gastroenterology Consultants of Southwest Virginia Roanoke Virginia United States 24014-1372
    34 Swedish Medical Center-First Hill Campus Issaquah Washington United States 98029
    35 Digestive Health Specialists Tacoma Washington United States 98405
    36 Medizinische Universität Graz Graz Austria 8036
    37 Medizinische Universität Innsbruck Innsbruck Austria 6020
    38 Universitätsklinikum Salzburg - Landeskrankenhaus Salzburg Austria 5020
    39 Akh Wien Wien Austria 1090
    40 Hopital Erasme Bruxelles Belgium 1070
    41 AZ Maria Middelares Gent Belgium 9000
    42 UZ Leuven Leuven Belgium 3000
    43 University of Calgary Calgary Alberta Canada T2N 4N1
    44 Gastroenterology and Internal Medicine Research Institute (GIRI) Edmonton Alberta Canada T5R 1W2
    45 Nova Scotia Health Authority Halifax Nova Scotia Canada B3H 2Y9
    46 University of Western Ontario London Health Science Centre London Ontario Canada N6A 5A5
    47 Mount Sinai Hospital-Toronto Toronto Ontario Canada M5G 1X5
    48 Toronto Digestive Disease Associates Inc Vaughan Ontario Canada L4L 4Y7
    49 McGill University Health Centre Montreal Quebec Canada H3G 1A4
    50 Covenant Health/Grey Nuns hospital Edmonton Canada T6K 4B2
    51 NH Hospital, a.s. Horovice Czechia 268 31
    52 FN Hradec Kralove Hradec Kralove Czechia 500 05
    53 Hepato-gastroenterologie HK, s.r.o. Hradec Kralove Czechia 500 12
    54 ISCARE a.s. Praha 9 Czechia 190 00
    55 CHRU Besançon -Hôpital Jean Minjoz Besançon Cedex France 25000
    56 CHRU Montpellier - Hopital Saint-Eloi Montpellier Cedex 5 France 34295
    57 CHU de Nice Hopital de l Archet Nice France 6202
    58 Hopital Saint-Louis Paris France 75010
    59 Centre Hospitalier Lyon Sud Pierre-Bénite France 69495
    60 CHU de Reims Reims France 51100
    61 CHU de Nancy - Hôpital de Brabois Vandoeuvre-les-Nancy France 54511
    62 Klinikum Augsburg Augsburg Germany 86156
    63 Charite - Universitatsmedizin Berlin (CCM) Berlin Germany 12200
    64 Charité Berlin Germany 13353
    65 Krankenhaus Waldfriede Mitte Berlin Germany 14163
    66 Universitätsklinikum Erlangen Medizinische Klinik I Erlangen Germany 91054
    67 Universitaetsklinikum Frankfurt Frankfurt Germany 60590
    68 Universitatsklinikum Freiburg Freiburg Germany 79110
    69 Medizinische Hochschule Hannover Hannover Germany 30625
    70 Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd Heidelberg Germany 69115
    71 Universitätsklinikum Heidelberg Heidelberg Germany 69115
    72 Universitätsklinikum Jena Jena Germany 07747
    73 Staedtisches Klinikum Lueneburg Lueneburg Germany 21339
    74 Universitatsklinikum Mannheim Mannheim Germany 68167
    75 Klinikum rechts der Isar der TU Munchen München Germany 81675
    76 Medius Klinik Nürtingen Nurtingen Germany 72622
    77 Siloah St. Trudpert Klinikum Pforzheim Germany 75179
    78 Universitätsklinikum Ulm Ulm Germany 89070
    79 Mh Egészségügyi Központ Budapest Hungary 1062
    80 Péterfy Sándor utcai Kórház Budapest Hungary 1076
    81 Semmelweis Egyetem Budapest Hungary 1082
    82 Semmelweis Egyetem Budapest Hungary H-1088
    83 Policlinico di Bari Ospedale Giovanni XXIII Bari Italy 70124
    84 Università degli studi di Bologna Bologna Italy 40138
    85 AOU Policlinico G.Martino Messina Italy 98125
    86 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano Italy 20122
    87 IRCCS Ospedale San Raffaele Milano Italy 20132
    88 Ospedale Sacro Cuore Don Calabria Negrar Ve Italy 37024
    89 A.O.R Villa Sofia Cervello Palermo Italy 90146
    90 Fatebenefratelli Isola Tiberina - Gemelli Isola Roma Italy 00/186
    91 Universita Campus Bio Medico[UOC Gastroenterologia] Roma Italy 00128
    92 A.O.U.Policlinico Tor Vergata Roma Italy 00133
    93 IRCCS Istituto Clinico Humanitas Rozzano Italy 20089
    94 IRCCS Policlinico San Donato San Donato Milanese (MI) Italy 20097
    95 Casa Sollievo della Sofferenza San Giovanni Rotondo Italy 71013
    96 Dong-A University Hospital Busan Korea, Republic of 49201
    97 Inje University Haeundae Paik Hospital Busan Korea, Republic of 612-030
    98 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    99 The Catholic University of Korea, Seoul St.Mary's Hospital Seoul Korea, Republic of 06591
    100 Kyung Hee University Hospital Seoul Korea, Republic of 2447
    101 Yonsei University Wonju Severance Christian Hospital Wonju, Gangwon-do Korea, Republic of 26426
    102 Academisch Medisch Centrum Universiteit van Amsterdam Amsterdam Netherlands 1105 AZ
    103 Maastricht Universitair Medisch Centrum Maastricht Netherlands 6229 HX
    104 Sint Franciscus Gasthuis Rotterdam Netherlands 3045 PM
    105 Stichting Zuyderland Medisch Centrum Sittard-Geleen Netherlands 6162 BG
    106 Elisabeth-TweeSteden Ziekenhuis Tilburg Netherlands 5022 GC
    107 UMC Utrecht Utrecht Netherlands 3584 CX
    108 Centrum Medyczne Medyk Rzeszow Poland 35-326
    109 H-T Centrum Medyczne Endoterapia Tychy Poland 43-100
    110 WIP Warsaw IBD Point Profesor Kierkus Warszawa Poland 00-728
    111 Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie Warszawa Poland 02-781
    112 Melita Medical Sp. z o.o. Wroclaw Poland 50-449
    113 University Clinical Hospital Center Dr Dragisa Misovic- Dedi Belgrade Serbia 11040
    114 Clinical Hospital Center Zvezdara Belgrade Serbia 11080
    115 Clinical Hospital Center Bezanijska Kosa Zemun Serbia 11080
    116 Hosp. Gral. Univ. de Alicante Alicante Spain 0-3010
    117 Hosp. Univ. Germans Trias I Pujol Badalona Spain 08916
    118 Hosp. Reina Sofia Cordoba Spain 14004
    119 Hosp. Arquitecto Marcide El Ferrol Spain 15405
    120 Hosp. Univ. de La Princesa Madrid Spain 28006
    121 Hosp. Univ. La Paz Madrid Spain 28046
    122 Hosp. Univ. de Torrejon Madrid Spain 28850
    123 Hosp. Univ. Central de Asturias Oviedo Spain 33011
    124 Hosp. de Navarra Pamplona Spain 31008
    125 Hosp. Clinico Univ. de Santiago Santiago De Compostela Spain 15706
    126 Hosp. Clinico Univ. De Valencia Valencia Spain 46010
    127 Hosp. Gral. Univ. Valencia Valencia Spain 46014
    128 Hosp. Clinico Univ. Lozano Blesa Zaragoza Spain 50009
    129 Hosp. Univ. Miguel Servet Zaragoza Spain 50009
    130 Royal Victoria Hospital Belfast United Kingdom BT12 6BA
    131 Fairfield General Hospital Bury United Kingdom BL9 7TD
    132 London North West University Healthcare NHS Trust Harrow United Kingdom HA1 3UJ
    133 Guy's and St Thomas' Hospital London United Kingdom SE1 7EH
    134 Nottingham University Hospitals NHS Trust Nottingham United Kingdom NG7 2UH
    135 Southampton University Hospitals NHS Trust Southampton United Kingdom SO16 6YD

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT05784129
    Other Study ID Numbers:
    • CR109292
    • 2022-002389-33
    • CNTO1959CRD3007
    First Posted:
    Mar 24, 2023
    Last Update Posted:
    Mar 24, 2023
    Last Verified:
    Mar 1, 2023
    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
    Keywords provided by Janssen Research & Development, LLC
    Endoscopy, Postoperative, Ileocolonic resection
    Additional relevant MeSH terms:
    Crohn Disease

    Study Results

    No Results Posted as of Mar 24, 2023