Recruiting NCT07196748

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

Phase III Interventional Colitis, Ulcerative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Icotrokinra, Placebo.
Who it may be relevant to: Registry conditions: Colitis, Ulcerative. Basic parameters: from 12 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Belgium, Brazil +23
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

Drug Icotrokinra
Icotrokinra tablet will be administered orally.
Drug Placebo
Placebo tablet will be administered orally.

Primary outcome measures

Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12 [Time frame: At Week I-12]
DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40 [Time frame: At Week M-40]
Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40 [Time frame: At Week M-40]

Secondary outcome measures (12)

DB Induction Study: Percentage of Adult Participants in Clinical Response at Week I-12 [Time frame: At Week I-12]
DB Induction Study: Percentage of Adult Participants with Endoscopic Improvement at Week I-12 [Time frame: At Week I-12]
DB Induction Study: Percentage of Adult Participants in Symptomatic Remission at Week I-12 [Time frame: At Week I-12]
DB Induction Study: Percentage of Adult Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12 [Time frame: At Week I-12]
DB Induction Study: Percentage of Adult Participants with Histologic-Endoscopic Mucosal Improvement (HEMI) at Week I-12 [Time frame: At Week I-12]
DB Induction Study: Percentage of Adult Participants with Fatigue Response at Week I-12 [Time frame: At Week I-12]
DB Induction Study: Percentage of Adult Participants in Symptomatic Remission at Week I-4 [Time frame: At Week I-4]
DB Induction Study: Percentage of Adult Participants in Endoscopic Remission at Week I-12 [Time frame: At Week I-12]
DB Induction Study: Percentage of Adult Participants with No Bowel Urgency at Week I-12 [Time frame: At Week I-12]
DB Induction Study: Percentage of Adult Participants with No Abdominal Pain at Week I-12 [Time frame: At Week I-12]
DB Induction Study: Percentage of Adult Participants with No Bowel Incontinence at Week I-12 [Time frame: At Week I-12]
DB Induction Study: Percentage of Adult Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Up to Week I-12]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment