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Clinical Trials in China / NCT06260163
Active, not recruiting Phase 3

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

NCT06260163 · tracked via the Priya Life Science China tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2024-01-19
Last updated
2026-08-28

Condition(s) studied

Colitis, Ulcerative

Investigational drug(s) / intervention(s)

Guselkumab SubcutaneousGuselkumab Intravenous

Guselkumab Subcutaneous: Guselkumab will be administered subcutaneously.

Guselkumab Intravenous: Guselkumab will be administered intravenously.

Study summary

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (61)

FacilityCityRegionStatus
Children's Hospital Oakland Oakland California
Riley Hospital for Children Indianapolis Indiana
NYU Langone Health Lake Success New York
The Kids Research Institute Australia on behalf of the Centre for Child Health Research Nedlands Australia
Mater Hospital Brisbane Inflammatory Bowel Diseases South Brisbane Australia
The Children's Hospital at Westmead Westmead Australia
CHU Charleroi Chimay Charleroi Belgium
UZ Gent Ghent Belgium
UZ Brussel Jette Belgium
UZ Leuven Leuven Belgium
Capital Center For Children's health Capital Medical University Beijing China
Peking University Third Hospital Beijing China
Changzhou No 2 Peoples Hospital Changzhou China
The Childrens Hospital Zhejiang University School Of Medicine Hangzhou China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine Hangzhou China
Ruijin Hospital Shanghai Jiao Tong University Shanghai China
Shengjing Hospital Of China Medical University Shenyang China
Henan Children's Hospital, Zhengzhou Children's Hospital Zhengzhou China
Aarhus Universitetshospital Aarhus N Denmark
Hvidovre Hospital Hvidovre Denmark
Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant Bron France
Hopital Francois Mitterand Dijon France
CHRU Lille Lille France
APHP Hopital Robert Debre Paris France
CHU Toulouse Toulouse France
ASST Papa Giovanni XXIII Bergamo Bergamo Italy
Azienda USL di Bologna - Ospedale Maggiore Bologna Italy
AOU Meyer Florence Italy
Ospedale S. Spirito, Azienda Sanitaria Pescara Pescara Italy
AOU Policlinico Umberto I Roma Italy
IRCCS Ospedale Pediatrico Bambino Gesu Roma Italy
Casa Sollievo della Sofferenza San Giovanni Rotondo Italy
IRCCS Materno Infantile Burlo Garofolo Trieste Italy
Tokyo Metropolitan Children's Medical Center Fuchū Japan
Kanazawa University Hospital Kanazawa Japan
Kobe University Hospital Kobe Japan
Japanese Red Cross Kumamoto Hospital Kumamoto Japan
Shinshu University Hospital Matsumoto Japan
Saga University Hospital Saga Japan
National Center for Child Health and Development Setagaya Ku Japan

+ 21 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06260163 on ClinicalTrials.gov ↗ ← All trials in China