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Active (not recruiting) Phase 3 NCT06260163

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Phase 3 – large-scale trial before approval
Conditions: Colitis, Ulcerative

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
Overview
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.
Who can participate
Inclusion Criteria: * Weight greater than or equal to (\>=) 10 kilogram (kg) at the time of consent for screening * A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC. * Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore \>= 2 as determined by a central review of the video of the endoscopy * Medically stable based on physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator * Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids Exclusion Criteria: * Have UC limited to the rectum only or to less than (\<) 20 centimeter of the colon * Presence of a stoma * Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline * Have severe colitis or have evidence of Crohn's Disease (CD)
Locations 12
Australia (1)
The Kids Research Institute Australia on behalf of the Centre for Child Health Research
Nedlands
Belgium (1)
CHU Charleroi Chimay
Charleroi
China (1)
Capital Center For Children's health Capital Medical University
Beijing
Denmark (1)
Aarhus Universitetshospital
Aarhus N
France (1)
Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
Bron
Italy (1)
ASST Papa Giovanni XXIII Bergamo
Bergamo
Japan (1)
Tokyo Metropolitan Children's Medical Center
Fuchū
Norway (1)
Akershus Universitetssykehus
Lørenskog
Poland (1)
Copernicus Podmiot Leczniczy Sp. z o.o
Gdansk
Spain (1)
Hosp. Infantil Univ. Nino Jesus
Madrid
Turkey (1)
Gazi University Medical Faculty
Ankara
United States (1)
Children's Hospital Oakland
Oakland , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
2 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
19.01.2024
Completion date
14.08.2028
Registry ID
NCT06260163
Source
anzctr
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