Recruiting NCT07196722

A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Phase II / Phase III Interventional Crohn Disease

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: Crohn Disease. Basic parameters: from 18 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 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Overview

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).

Interventions

Drug Icotrokinra
Icotrokinra will be administered orally, daily.
Drug Placebo
Matching placebo will be administered orally, daily.

Primary outcome measures

Induction Study 1: Number of Participants with Clinical Response at Week 12 [Time frame: At Week 12]
Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint) [Time frame: At Week 12]
Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint) [Time frame: At Week 12]
Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint) [Time frame: At Week 40]
Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint) [Time frame: At Week 40]

Secondary outcome measures (12)

Induction Study 1: Number of Participants with Clinical Remission at Week 12 [Time frame: At Week 12]
Induction Study 1: Number of Participants with Endoscopic Response at Week 12 [Time frame: At Week 12]
Induction Study 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Up to 4 weeks after last dose of study drug (i.e., up to Week 16)]
Induction Study 2: Number of Participants with Patient Reported Outcomes (PRO)-2 Remission at Week 12 [Time frame: At Week 12]
Induction Study 2: Number of Participants with Clinical Response at Week 12 [Time frame: At Week 12]
Induction Study 2: Number of Participants Reporting Both Clinical Remission and Endoscopic Response at Week 12 [Time frame: At Week 12]
Induction Study 2: Number of Participants with Clinical Response at Week 4 [Time frame: At Week 4]
Induction Study 2: Number of Participants with Endoscopic Remission at Week 12 [Time frame: At Week 12]
Induction Study 2: Number of Participants with Deep Remission at Week 12 [Time frame: At Week 12]
Induction Study 2: Number of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12 [Time frame: At Week 12]
Induction Study 2: Number of Participants with Fatigue Response at Week 12 [Time frame: At Week 12]
Induction Study 2: Number of Participants with Clinical Remission at Week 4 [Time frame: At Week 4]

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

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