Last updated 20 days ago
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
1092 patients around the world
Available in Argentina, United States, Brazil
Janssen Research & Development, LLC
2Research sites
1092Patients around the world
This study is for people with
Crohn's disease
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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, loss of response, or failure to tolerate previous conventional therapy (advanced drug therapy [ADT]-naïve) or 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.
Sites
Centro Medico GEDYT Gastroenterología Diagnóstica y Terapéutica
Recruiting
Pesquisare Saude
Recruiting
StudyICONIC-CD
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Crohn's disease
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07196722
