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A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
NCT07196748 · Janssen Research & Development, LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).
Eligibility criteria
Inclusion 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
* Adolescent Participants: body weight must be \>= 40 kilograms (kg) at baseline (Week I-0)
* Adult female participants of childbearing potential and all adolescent female participants 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 to, or failure to tolerate conventional therapy but are naïve to advanced therapies (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 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
Study design
Enrollment target: 882 participants
Allocation: randomized
Masking: double
Age groups: child, adult, older_adult
Timeline
Starts: 2025-10-01
Estimated completion: 2032-01-13
Last updated: 2026-04-13
Interventions
Drug: IcotrokinraDrug: Placebo
Primary outcomes
- • Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12 (At Week I-12)
- • DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40 (At Week M-40)
- • Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40 (At Week M-40)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical trial · study_director, Janssen Research & Development, LLC
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Charlotte, North Carolina, United States
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Foshan, China
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Guangzhou, China
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Guangzhou, China
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Linköping, Sweden
Orebro universitetssjukhusRecruiting
Örebro, Sweden
Ersta sjukhusRecruiting
Stockholm, Sweden
Karolinska Universitetssjukhuset SolnaRecruiting
Stockholm, Sweden
Akademiska SjukhusetRecruiting
Uppsala, Sweden
Department of Visceral Surgery and MedicineRecruiting
Bern, Switzerland
HOCH Health Ostschweiz Kantonsspital St.GallenRecruiting
Sankt Gallen, Switzerland
Changhua Christian HospitalRecruiting
Changhua, Taiwan
Kaohsiung Chang Gung Memorial HospitalRecruiting
Kaohsiung City, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Mackay Memorial HospitalRecruiting
Taipei, Taiwan
Linkou Chang Gung Memorial HospitalRecruiting
Taoyuan District, Taiwan
Hacettepe University Medical FacultyRecruiting
Ankara, Turkey (Türkiye)
Gazi University Hospital 1Recruiting
Ankara, Turkey (Türkiye)
Gazi University HospitalRecruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir HastanesiRecruiting
Ankara, Turkey (Türkiye)
Antalya Training And Research HospitalRecruiting
Antalya, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical FacultyRecruiting
Istanbul, Turkey (Türkiye)
Marmara University Istanbul Pendik Education and Research HospitalRecruiting
Istanbul, Turkey (Türkiye)
Marmara University Istanbul Pendik Education and Research Hospital 1Recruiting
Istanbul, Turkey (Türkiye)
Ege University Medical FacultyRecruiting
Izmir, Turkey (Türkiye)
Kocaeli University Medical FacultyRecruiting
Kocaeli, Turkey (Türkiye)
Mersin University Medical Faculty HospitalRecruiting
Mersin, Turkey (Türkiye)
Addenbrooke's HospitalRecruiting
Cambridge, United Kingdom
Royal Hospital for Children and Young PeopleRecruiting
Edinburgh, United Kingdom
Fairfield General HospitalRecruiting
Greater Manchester, United Kingdom
Whipps Cross University HospitalRecruiting
London, United Kingdom
Kings College HospitalRecruiting
London, United Kingdom
St Georges University Hospitals NHS Foundation TrustRecruiting
London, United Kingdom
Whiston HospitalRecruiting
Rainhill, United Kingdom
Sheffield Children's HospitalRecruiting
Sheffield, United Kingdom
Stepping Hill HospitalRecruiting
Stockport, United Kingdom