NCT07196722 A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
| NCT ID | NCT07196722 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Janssen Research & Development, LLC |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,092 participants |
| Start Date | 2025-10-03 |
| Primary Completion | 2028-09-19 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,092 participants in total. It began in 2025-10-03 with a primary completion date of 2028-09-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
Eligibility Criteria
Inclusion Criteria: * Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD * 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 to, or failure to tolerate conventional therapy but naïve to advanced therapies (advanced drug therapy \[ADT\]-naïve) or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate 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: * Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention * 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
Contact & Investigator
Janssen Research & Development, LLC Clinical Trial
STUDY DIRECTOR
Janssen Research & Development, LLC
Frequently Asked Questions
Who can join the NCT07196722 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07196722 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07196722 currently recruiting?
Yes, NCT07196722 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07196722 trial being conducted?
This trial is being conducted at Chandler, United States, Litchfield Park, United States, Scottsdale, United States, Anaheim, United States and 11 additional locations.
Who is sponsoring the NCT07196722 clinical trial?
NCT07196722 is sponsored by Janssen Research & Development, LLC. The principal investigator is Janssen Research & Development, LLC Clinical Trial at Janssen Research & Development, LLC. The trial plans to enroll 1,092 participants.