Digestive Health Clinical Trials
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease (ICONIC-CD)
Learn moreWhat is the purpose of this study?
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
- 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
- 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
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
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
- Disease Type/ConditionCrohn Disease
- Principal InvestigatorCaroline Hwang, MD
- Co-InvestigatorsRashmi Kumar, MD, Monica McCawley, NP
- Age GroupAdult, Older Adult
- PhaseIII
- ClinicalTrials.gov IDNCT07196722
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Laurie Hendricks, MSN, RN, OCN
laurie.hendricks@hoag.org
Hoag Digestive Health Institute
Hoag Digestive Health Institute provides advanced, comprehensive care for the full spectrum of digestive conditions, with access to world-class specialists, diagnostics and imaging, advanced interventional therapeutics, and clinical trials. Patients benefit from a research-driven approach that connects leading-edge treatment options with personalized care across gastroenterology and GI surgery.
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