Clinical Trials List
2025-09-01 - 2032-10-06
Phase II/III
Recruiting5
ICD-10K50.00
Crohn's disease of small intestine without complications
ICD-10K50.011
Crohn's disease of small intestine with rectal bleeding
ICD-10K50.018
Crohn's disease of small intestine with other complication
ICD-10K50.019
Crohn's disease of small intestine with unspecified complications
ICD-9555.0
Regional enteritis, small intestine
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
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Trial Applicant
Johnson & Johnson
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Sponsor
Janssen Research & Development, LLC
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 謝銘鈞 無
- 陳知澈 無
- 吳嘉峯 無
- 翁孟慈 無
- YEN-HSUAN NI 無
- 吳心耘 無
- Huey-Ling Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 姚志謙 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
2.Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint)
3.Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint)
4.Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint)
5.Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint)
Inclution 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, 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
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
The Estimated Number of Participants
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Taiwan
25 participants
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Global
1092 participants
