Clinical Trials List
2025-09-01 - 2032-01-13
Phase III
Recruiting5
ICD-10K51.90
Ulcerative colitis, unspecified, without complications
ICD-10K51.911
Ulcerative colitis, unspecified with rectal bleeding
ICD-10K51.912
Ulcerative colitis, unspecified with intestinal obstruction
ICD-10K51.913
Ulcerative colitis, unspecified with fistula
ICD-10K51.914
Ulcerative colitis, unspecified with abscess
ICD-10K51.918
Ulcerative colitis, unspecified with other complication
ICD-10K51.919
Ulcerative colitis, unspecified with unspecified complications
ICD-9556.9
Ulcerative colitis, unspecified
A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis
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Trial Applicant
Johnson & Johnson
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Sponsor
JOHNSON & JOHNSON TAIWAN LTD.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 吳嘉峯 無
- 謝銘鈞 無
- 吳心耘 無
- Huey-Ling Chen 無
- 翁夢慈 無
- YEN-HSUAN NI 無
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
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12
DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40
Inclution Criteria
• Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC
• Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy
• An endoscopy subscore greater than or equal to (>=) 2 as obtained during central review of the screening video endoscopy
• For adolescent participants >=12 to less than (<) 18 years of age, body weight must be >=40 kilograms (kg) at baseline (Week I-0)
• A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [β-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 UC (ADT-inadequate responder [IR]) as defined in the protocol
Exclusion Criteria
• Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study
• Presence of a stoma
• Presence or history of a fistula
• Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline
• History of extensive colonic resection (that is, less than [<] 30 centimeter [cm] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention
The Estimated Number of Participants
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Taiwan
25 participants
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Global
822 participants
