ClinicaliQ Trial Snapshot
- A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn’s Disease — Recruiting • Phase II • Rheumatology • NCT07196722.
- Drug being tested: Icotrokinra, a novel therapeutic agent, is being evaluated for its efficacy and safety profile in treating moderately to severely active Crohn's disease, an inflammatory bowel condition characterised by significant intestinal inflammation.
- Patient eligibility overview: The trial focuses on patients with confirmed moderately to severely active Crohn's disease; specific inclusion/exclusion criteria would typically encompass disease activity markers, prior treatment history, and baseline inflammatory parameters.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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).
Eligibility Snapshot
- : * 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 =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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.