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Icotrokinra for Moderately to Severely Active Ulcerative Colitis

This study is testing a new oral medication called icotrokinra for adults and adolescents with moderately to severely active ulcerative colitis (UC), a chronic disease causing inflammation and ulcers in the large intestine. Researchers want to see how well icotrokinra works and if it is safe compared to a placebo (an inactive tablet). To join, you must have a confirmed diagnosis of UC for at least 12 weeks and have moderately to severely active UC. The study will measure success by looking at the percentage of participants who achieve clinical remission (when symptoms improve or disappear) at specific time points, including Week I-12 and Week M-40. The study plans to enroll 882 participants, but its current recruitment status is unclear.

Study design
This interventional study involves giving participants either icotrokinra or a placebo. It is designed to be double-blind for the induction and maintenance phases, meaning neither you nor your doctor will know which treatment you are receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures clinical remission at Week I-12 and Week M-40, suggesting follow-up for at least 40 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07196748

A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis

Recruiting
PHASE3Ages 12+InterventionalTreatment
Janssen Research & Development, LLC
~882 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:IcotrokinraPlacebo

At a glance

Recruiting sites
390 of 401 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12
Measured over At Week I-12
+2 more outcomes measured

Conditions

Colitis, Ulcerative

Explore related trials

Ulcerative Colitis

Where it's being run

401 sites across 52 states
China34
Japan34
Poland29
Brazil22
India19
France17
Germany15
Israel15

Study leadership

  • Janssen Research & Development, LLC Clinical trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC
Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy
An endoscopy subscore greater than or equal to (\>=) 2 as obtained during central review of the screening video endoscopy
Adolescent Participants: body weight must be \>= 40 kilograms (kg) at baseline (Week I-0)
Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[β-hCG\]) 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 are naïve to advanced therapies (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 UC (ADT-inadequate responder \[IR\]) as defined in the protocol

Exclusion

Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study
Presence of a stoma
Presence or history of a fistula
Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline
History of extensive colonic resection (that is, less than \[\<\] 30 centimeter \[cm\] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention

What this trial measures

  • Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12At Week I-12

    Percentage of adult participants in clinical remission at Week I-12 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

  • DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40At Week M-40

    Percentage of adult participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.

  • Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40At Week M-40

    Percentage of adolescent participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.