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RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests icotrokinra, a medicine taken by mouth, in adults and teens with moderate to severe active ulcerative colitis. This long-term disease causes swelling and small open sores in the large intestine. The study checks how well the medicine works, its safety, and how well people can tolerate it.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Were diagnosed with ulcerative colitis at least 12 weeks before screening, confirmed by a camera exam of the bowel and a tissue sample report.
  • Have moderate to severe active disease, with a modified Mayo score of 5 to 9 at the study start. This score measures how active the disease is.
  • Have a bowel camera exam score of at least 2, confirmed by the study’s central review team.
  • Teens must weigh at least 40 kilograms (about 88 pounds) at the study start.
  • Adult females who can become pregnant and all teen females must have negative blood and urine pregnancy tests before treatment and agree to more tests.
  • Have tried standard treatment that did not work well enough or caused side effects they could not tolerate, and have never used advanced treatments; OR have tried advanced treatments, such as biologic medicines or advanced pills, that did not work well enough or could not be tolerated.

Who can't join

  • Have known complications of ulcerative colitis, such as very severe bowel inflammation, dangerous swelling of the colon, or another problem that may require colon surgery during the study.
  • Have a stoma, an opening made by surgery to let waste leave the body.
  • Have or have ever had a fistula, an abnormal tunnel between body parts.
  • Had part of the colon removed within 24 weeks before the study start, or had other surgery inside the belly or other major surgery within 12 weeks before the study start.
  • Had colon surgery that left less than 30 centimeters (about 12 inches) of colon, or that could make it hard to measure disease severity and response to treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 * 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 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

Study sites (56)

AZ

CA

CO

CT

FL

GA

IN

KS

KY

LA

MD

NC

NY

OK

OR

PA

RI

SC

TX

VA

WA