Last updated 20 days ago
A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
882 patients around the world
Available in Argentina, United States
Janssen Research & Development, LLC
1Research sites
882Patients around the world
This study is for people with
Ulcerative colitis
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- 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).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, 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.
- 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.
Sites
Centro Medico GEDYT Gastroenterología Diagnóstica y Terapéutica
Recruiting
StudyICONIC-UC
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Ulcerative colitis
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07196748
