Clinical trial NCT06260163: A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Colitis, Ulcerative
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-02-15
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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)

Primary outcomes:
measure: Percentage of Participants with Clinical Remission at Week 56
timeFrame: Week 56
Secondary outcomes:
measure: Percentage of Participants with Clinical Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants with Clinical Remission at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12
timeFrame: Week 12
measure: Percentage of Participants with Symptomatic Remission at Week 12
timeFrame: Week 12
measure: United States: Percentage of Participants with Endoscopic Improvement at Week 12
timeFrame: Week 12
measure: European Union: Percentage of Participants with Endoscopic Healing at Week 12
timeFrame: Week 12
measure: Percentage of Participants with Clinical Response at Week 56
timeFrame: Week 56
measure: Percentage of Participants With PUCAI Remission at Week 56
timeFrame: Week 56
measure: Percentage of Participants with Symptomatic Remission at Week 56
timeFrame: Week 56
measure: Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12
timeFrame: Week 56
measure: United States: Percentage of Participants With Endoscopic Improvement at Week 56
timeFrame: Week 56
measure: European Union: Percentage of Participants With Endoscopic Healing at Week 56
timeFrame: Week 56
measure: Percentage of Participants Who Achieve Endoscopic Normalization at Week 56
timeFrame: Week 56
measure: Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56
timeFrame: Week 56
measure: Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56
timeFrame: Week 56
measure: Serum Concentration of Guselkumab During Induction Phase
timeFrame: From Week 0 to Week 12
measure: Serum Concentration of Guselkumab During Maintenance Phase
timeFrame: From Week 12 to Week 56
measure: Number of Participants with Incidence of Anti-guselkumab Antibodies
timeFrame: Up to Week 68
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to Week 68
measure: Percentage of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Week 68
measure: Percentage of Participants with AEs Leading to Discontinuation of Study Intervention
timeFrame: Up to Week 68
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Children's Hospital Oakland
state: California
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Lake Success
country: United States
facility: NYU Langone Health
state: New York
city: Nedlands
country: Australia
facility: The Kids Research Institute Australia on behalf of the Centre for Child Health Research
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane Inflammatory Bowel Diseases
city: Westmead
country: Australia
facility: The Children's Hospital at Westmead
city: Charleroi
country: Belgium
facility: CHU Charleroi Chimay
city: Gent
country: Belgium
facility: UZ Gent
city: Jette
country: Belgium
facility: UZ Brussel
city: Leuven
country: Belgium
facility: UZ Leuven
city: Beijing
country: China
facility: Capital Institute of Pediatrics
city: Beijing
country: China
facility: Peking University Third Hospital
city: Changzhou City
country: China
facility: Changzhou No 2 Peoples Hospital
city: Hangzhou
country: China
facility: The Childrens Hospital Zhejiang University School Of Medicine
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: ZhengZhou
country: China
facility: Henan Children's Hospital, Zhengzhou Children's Hospital
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Bron cedex
country: France
facility: Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
city: Dijon
country: France
facility: Hopital Francois Mitterand
city: Lille Cedex
country: France
facility: CHRU Lille
city: Paris
country: France
facility: APHP Hopital Robert Debre
city: Toulouse
country: France
facility: CHU Toulouse
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII Bergamo
city: Bologna
country: Italy
facility: Azienda USL di Bologna - Ospedale Maggiore
city: Firenze
country: Italy
facility: AOU Meyer
city: Pescara
country: Italy
facility: Ospedale S. Spirito, Azienda Sanitaria Pescara
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
city: Roma
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesu
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza
city: Trieste
country: Italy
facility: IRCCS Materno Infantile Burlo Garofolo
city: Fuchu
country: Japan
facility: Tokyo Metropolitan Children's Medical Center
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Kumamoto
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
city: Saga
country: Japan
facility: Saga University Hospital
city: Setagaya Ku
country: Japan
facility: National Center for Child Health and Development
city: Shinjuku
country: Japan
facility: Tokyo Medical University Hospital
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
city: Yokohama
country: Japan
facility: Saiseikai Yokohamashi Tobu Hospital
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Tromso
country: Norway
facility: Universitetssykehuset Nord-Norge HF
city: Trondheim
country: Norway
facility: St. Olavs Hospital
city: Gdansk
country: Poland
facility: Copernicus Podmiot Leczniczy Sp. z o.o
city: Rzeszow
country: Poland
facility: Korczowski Bartosz Gabinet Lekarski
city: Warszawa
country: Poland
facility: Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
city: Warszawa
country: Poland
facility: Instytut Pomnik Centrum Zdrowia Dziecka
city: Lisboa
country: Portugal
facility: Uls Santa Maria - Hosp. Santa Maria
city: Porto
country: Portugal
facility: Uls Santo Antonio - Cmin
city: Porto
country: Portugal
facility: Uls Sao Joao - Hosp. Sao Joao
city: Madrid
country: Spain
facility: Hosp. Infantil Univ. Nino Jesus
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: València
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: