A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults With an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis

Investigating Medicine Effects on Ulcerative Colitis

M
Monika Fischer, MD

Primary Investigator

Enrolling By Invitation
12 years or above
All
Phase 3
1 participants needed
1 Location

Brief description of study

The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12 [Time Frame: At Week I-12] Percentage of adult participants in clinical remission at Week I-12 will be reported. Clinical remission is defined as stool frequency sub score of 0 or 1, a rectal bleeding sub score of 0, and an endoscopy sub score of 0 or 1. DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40 [Time Frame: At Week M-40] Percentage of adult participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency sub score of 0 or 1, a rectal bleeding sub score of 0, and an endoscopy sub score of 0 or 1. Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40 [Time Frame: At Week M-40] Percentage of adolescent participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency sub score of 0 or 1, a rectal bleeding sub score of 0, and an endoscopy sub score of 0 or 1.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ulcerative Colitis
  • Age: 12 years or above
  • Gender: All

Inclusion Criteria:

  • 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
  • For adolescent participants >=12 to less than (<) 18 years of age, 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, 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 UC (ADT-inadequate responder [IR]) as defined in the protocol

Exclusion Criteria:

  • 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

This study investigates the effects of an investigational medication on people with moderately to severely active ulcerative colitis, a chronic disease where the colon's lining becomes inflamed and develops tiny open ulcers. The study involves adults and adolescents and aims to understand the medication's efficacy and safety as a therapy option.

Participants will be randomly assigned to receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will measure clinical remission, which means having fewer symptoms like reduced stool frequency and rectal bleeding, and improved endoscopy results.

  • Who can participate: Participants must be diagnosed with ulcerative colitis for at least 12 weeks. Adolescents aged 12 to 17 must weigh at least 40 kilograms. Participants must have shown an inadequate response to previous therapies.
  • Study details: Participants will take either the investigational medication or a placebo. An inactive substance that looks like the investigational medicine/vaccine but does not contain any medicine. The study will monitor for clinical remission, defined by specific symptom scores, to assess the medication's effectiveness.
Updated on 23 Jul 2026. Study ID: GI-JANSSEN-ICONIC-UC, 31960
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only