A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
NCT ID: NCT07196722
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
1092 participants
INTERVENTIONAL
2025-10-03
2032-10-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Induction Study 1: Icotrokinra Dose 1
Participants will receive Icotrokinra dose 1 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Icotrokinra
Icotrokinra will be administered orally, daily.
Induction Study 1: Icotrokinra Dose 2
Participants will receive Icotrokinra dose 2 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Icotrokinra
Icotrokinra will be administered orally, daily.
Induction Study 1: Placebo
Participants will receive matching placebo in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Placebo
Matching placebo will be administered orally, daily.
Induction Study 2: Icotrokinra
Participants will receive Icotrokinra at the dose regimen determined in Induction Study 1 up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
Icotrokinra
Icotrokinra will be administered orally, daily.
Induction Study 2: Placebo
Participants will receive matching placebo for up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
Placebo
Matching placebo will be administered orally, daily.
Maintenance Study: Icotrokinra Dose 1
Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 1. Participants receiving Icotrokinra Dose 1 and meeting criteria for loss of response during the Maintenance Study will be eligibile for a single blinded dose adjustment to Icotrokinra Dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in long-term extension (LTE).
Icotrokinra
Icotrokinra will be administered orally, daily.
Maintenance Study: Icotrokinra Dose 2
Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 2. Participants who were non-responders at Week 12 of the induction studies will also receive icotrokinra maintenance dose 2 but will not be randomized. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.
Icotrokinra
Icotrokinra will be administered orally, daily.
Maintenance Study: Placebo
Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 will be randomized to receive placebo. Participants receiving placebo in induction studies 1 or 2 and in response at Week 12 of the induction study will continue to receive placebo during maintenance on non-randomized basis. Placebo non-responders from induction study will receive icotrokinra maintenance dose 2 on a non-randomized basis and will be assessed for response at Week 12.
Participants receiving placebo and meeting criteria for loss of response during the Maintenance Study will be eligible for a single blinded dose adjustment to icotrokinra dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.
Icotrokinra
Icotrokinra will be administered orally, daily.
Placebo
Matching placebo will be administered orally, daily.
Interventions
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Icotrokinra
Icotrokinra will be administered orally, daily.
Placebo
Matching placebo will be administered orally, daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \>=220 but \<=450 and either mean daily SF count \>=4, or mean daily AP score \>=2
* Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD \>= 6 for participants with colonic or ileocolonic disease, and SES-CD \>= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments
* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests
* Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy (advanced drug therapy \[ADT\]-naïve) or advanced therapy defined as biologics and/or advanced oral agents for the treatment of CD (ADT-inadequate responder \[IR\]) as defined in the protocol
Exclusion Criteria
* Presence of a stoma or ostomy
* Participants with presence of active fistulas may be included if there is no surgery needed
* Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline
* Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Clinnova Research
Anaheim, California, United States
Alliance Research Institute, LLC - Canoga Park
Canoga Park, California, United States
Om Research LLC
Lancaster, California, United States
TLC Clinical Research Inc
Los Angeles, California, United States
GastroIntestinal Bioscience
Los Angeles, California, United States
Om Research LLC
Oxnard, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
American Institute of Research
Cutler Bay, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Green Leaf Clinical Trials
Jacksonville, Florida, United States
GCP Clinical Research
Tampa, Florida, United States
Children's Center for Digestive Health Care
Atlanta, Georgia, United States
Gastroenterolgy Associates of Central GA
Macon, Georgia, United States
Kansas Gastroenterology, LLC
Wichita, Kansas, United States
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, United States
Delta Research Partners, LLC
West Monroe, Louisiana, United States
Westchester Putnam Gastroenterology
Carmel, New York, United States
New York Gastroenterology Associates
New York, New York, United States
Gastro Intestinal Research Institute of Northern Ohio LLC
Westlake, Ohio, United States
The Oregon Clinic
Portland, Oregon, United States
Susquehanna Research Group
Harrisburg, Pennsylvania, United States
DFW Clinical Trials
Carrollton, Texas, United States
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Mater Hospital Brisbane
South Brisbane, , Australia
Barrie GI Associates
Barrie, Ontario, Canada
ABP Research Services Corp.
Oakville, Ontario, Canada
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario, Canada
Kagoshima IBD Gastroenterology Clinic
Kagoshima, , Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, , Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, , Japan
Takagi Clinic
Miyagi, , Japan
Nakagami Hospital
Okinawa, , Japan
Sapporo Tokushukai Hospital
Sapporo, , Japan
Matsuda Hospital
Shizuoka, , Japan
National Hospital Organization Shizuoka Medical Center
Sunto-gun, , Japan
Hospital Sultanah Bahiyah
Alor Star, , Malaysia
Hospital Sultanah Aminah
Johor Bahru, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
Glasgow Royal Infirmary
Glasgow, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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77242113CRD3001
Identifier Type: OTHER
Identifier Source: secondary_id
2025-521382-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
77242113CRD3001
Identifier Type: -
Identifier Source: org_study_id