Evaluating Guselkumab for Children with Active Ulcerative Colitis
A Phase 3 Randomized, Open-label Induction, Double-blind Maintenance, Parallel-group, Multicenter Protocol to Evaluate the Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
This study is testing if the medication guselkumab can help children with moderate to severe ulcerative colitis feel better after they have responded to initial treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | guselkumab |
| Locations | 61 sites (Oakland, California and 60 other locations) |
| Trial ID | NCT06260163 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of guselkumab, administered both subcutaneously and intravenously, in pediatric patients suffering from moderately to severely active ulcerative colitis. Participants must have shown a positive response to induction therapy and will be evaluated at the end of maintenance therapy. The study will involve a thorough screening process to confirm the diagnosis and severity of the condition using established clinical criteria.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 10 kg or more with a documented diagnosis of moderately to severely active ulcerative colitis.
Not a fit: Patients with mild ulcerative colitis or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of ulcerative colitis in children, leading to better health outcomes.
How similar studies have performed: Previous studies have shown promising results with similar biologic therapies for ulcerative colitis, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Oakland, California and 60 other locations
- Children's Hospital Oakland — Oakland, California, United States (Recruiting)
- Riley Hospital for Children — Indianapolis, Indiana, United States (Recruiting)
- NYU Langone Health — Lake Success, New York, United States (Recruiting)
- The Kids Research Institute Australia on behalf of the Centre for Child Health Research — Nedlands, Australia (Recruiting)
- Mater Hospital Brisbane Inflammatory Bowel Diseases — South Brisbane, Australia (Recruiting)
- The Children's Hospital at Westmead — Westmead, Australia (Recruiting)
- CHU Charleroi Chimay — Charleroi, Belgium (Recruiting)
- UZ Gent — Gent, Belgium (Recruiting)
- UZ Brussel — Jette, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- Capital Institute of Pediatrics — Beijing, China (Recruiting)
- Peking University Third Hospital — Beijing, China (Recruiting)
- Changzhou No 2 Peoples Hospital — Changzhou City, China (Recruiting)
- The Childrens Hospital Zhejiang University School Of Medicine — Hangzhou, China (Recruiting)
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou, China (Recruiting)
- Ruijin Hospital Shanghai Jiao Tong University — Shanghai, China (Recruiting)
- Shengjing Hospital Of China Medical University — Shenyang, China (Recruiting)
- Henan Children's Hospital, Zhengzhou Children's Hospital — ZhengZhou, China (Recruiting)
- Aarhus Universitetshospital — Aarhus N, Denmark (Recruiting)
- Hvidovre Hospital — Hvidovre, Denmark (Recruiting)
- Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant — Bron cedex, France (Recruiting)
- Hopital Francois Mitterand — Dijon, France (Recruiting)
- CHRU Lille — Lille Cedex, France (Recruiting)
- APHP Hopital Robert Debre — Paris, France (Recruiting)
- CHU Toulouse — Toulouse, France (Recruiting)
- ASST Papa Giovanni XXIII Bergamo — Bergamo, Italy (Recruiting)
- Azienda USL di Bologna - Ospedale Maggiore — Bologna, Italy (Recruiting)
- AOU Meyer — Firenze, Italy (Recruiting)
- Ospedale S. Spirito, Azienda Sanitaria Pescara — Pescara, Italy (Recruiting)
- AOU Policlinico Umberto I — Roma, Italy (Recruiting)
- IRCCS Ospedale Pediatrico Bambino Gesu — Roma, Italy (Recruiting)
- Casa Sollievo della Sofferenza — San Giovanni Rotondo, Italy (Recruiting)
- IRCCS Materno Infantile Burlo Garofolo — Trieste, Italy (Recruiting)
- Tokyo Metropolitan Children's Medical Center — Fuchu, Japan (Recruiting)
- Kanazawa University Hospital — Kanazawa, Japan (Recruiting)
- Kobe University Hospital — Kobe, Japan (Recruiting)
- Japanese Red Cross Kumamoto Hospital — Kumamoto, Japan (Recruiting)
- Shinshu University Hospital — Matsumoto, Japan (Recruiting)
- Saga University Hospital — Saga, Japan (Recruiting)
- National Center for Child Health and Development — Setagaya Ku, Japan (Recruiting)
- Tokyo Medical University Hospital — Shinjuku, Japan (Recruiting)
- Osaka Medical and Pharmaceutical University Hospital — Takatsuki, Japan (Recruiting)
- Saiseikai Yokohamashi Tobu Hospital — Yokohama, Japan (Recruiting)
- Akershus Universitetssykehus — Lørenskog, Norway (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- Universitetssykehuset Nord-Norge HF — Tromso, Norway (Recruiting)
- St. Olavs Hospital — Trondheim, Norway (Recruiting)
- Copernicus Podmiot Leczniczy Sp. z o.o — Gdansk, Poland (Recruiting)
- Korczowski Bartosz Gabinet Lekarski — Rzeszow, Poland (Recruiting)
- Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus — Warszawa, Poland (Recruiting)
+11 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.