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

NCT06260163 | Active Not Recruiting Phase 3 DMC FDA Drug

• 4 other identifiers: CR109251CNTO1959PUC30012022-001285-352022-502238-22-00
• Study Type: interventional
• Target: 112
• Locations: 13 countries
• Sites: 61

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.

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Clinical Remission at Week 56

  Percentage of participants with clinical remission as assessed by modified Mayo score at Week 56 among participants who were induction responders will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.

  Week 56

Secondary Outcomes (21)

• Percentage of Participants with Clinical Response at Week 12

  Week 12

• Percentage of Participants with Clinical Remission at Week 12

  Week 12

• Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12

  Week 12

• Percentage of Participants with Symptomatic Remission at Week 12

  Week 12

• United States: Percentage of Participants with Endoscopic Improvement at Week 12

  Week 12

Study Arms (5)

Open-label Induction Phase: Guselkumab Intravenously (IV)

EXPERIMENTAL

Participants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase.

Drug: Guselkumab Intravenous

Open-label Induction Phase: Guselkumab Subcutaneously (SC)

EXPERIMENTAL

Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase.

Drug: Guselkumab Subcutaneous

Double-blind Maintenance Phase: Guselkumab Dose Regimen 1

EXPERIMENTAL

At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their BW up to Week 56.

Drug: Guselkumab Subcutaneous

Double-blind Maintenance Phase: Guselkumab Dose Regimen 2

EXPERIMENTAL

At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their BW up to Week 56.

Drug: Guselkumab Subcutaneous

Open-label Maintenance Phase: Guselkumab SC

EXPERIMENTAL

Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 56.

Drug: Guselkumab Subcutaneous

Interventions

Guselkumab Subcutaneous DRUG

Guselkumab will be administered subcutaneously.

Also known as: CNTO1959, TREMFYA

Double-blind Maintenance Phase: Guselkumab Dose Regimen 1; Double-blind Maintenance Phase: Guselkumab Dose Regimen 2; Open-label Induction Phase: Guselkumab Subcutaneously (SC); Open-label Maintenance Phase: Guselkumab SC

Guselkumab Intravenous DRUG

Guselkumab will be administered intravenously.

Also known as: CNTO1959, TREMFYA

Open-label Induction Phase: Guselkumab Intravenously (IV)

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (61)

Children's Hospital Oakland

Oakland, California, 94609, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

NYU Langone Health

Lake Success, New York, 11042, United States

Location

The Kids Research Institute Australia on behalf of the Centre for Child Health Research

Nedlands, 6009, Australia

Location

Mater Hospital Brisbane Inflammatory Bowel Diseases

South Brisbane, 4101, Australia

Location

The Children's Hospital at Westmead

Westmead, 2145, Australia

Location

CHU Charleroi Chimay

Charleroi, 6042, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Brussel

Jette, 1090, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Capital Center For Children's health Capital Medical University

Beijing, 100020, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

Changzhou No 2 Peoples Hospital

Changzhou, 213004, China

Location

The Childrens Hospital Zhejiang University School Of Medicine

Hangzhou, 310005, China

Location

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310016, China

Location

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, 200025, China

Location

Shengjing Hospital Of China Medical University

Shenyang, 110004, China

Location

Henan Children's Hospital, Zhengzhou Children's Hospital

Zhengzhou, 450052, China

Location

Aarhus Universitetshospital

Aarhus N, 8200, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant

Bron, 69677, France

Location

Hopital Francois Mitterand

Dijon, 21000, France

Location

CHRU Lille

Lille, 59037, France

Location

APHP Hopital Robert Debre

Paris, 75019, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

ASST Papa Giovanni XXIII Bergamo

Bergamo, 24127, Italy

Location

Azienda USL di Bologna - Ospedale Maggiore

Bologna, 40133, Italy

Location

AOU Meyer

Florence, 50139, Italy

Location

Ospedale S. Spirito, Azienda Sanitaria Pescara

Pescara, 65124, Italy

Location

AOU Policlinico Umberto I

Roma, 00161, Italy

Location

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, 00165, Italy

Location

Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

IRCCS Materno Infantile Burlo Garofolo

Trieste, 34137, Italy

Location

Tokyo Metropolitan Children's Medical Center

Fuchū, 183 8561, Japan

Location

Kanazawa University Hospital

Kanazawa, 920 8641, Japan

Location

Kobe University Hospital

Kobe, 650 0017, Japan

Location

Japanese Red Cross Kumamoto Hospital

Kumamoto, 861 8520, Japan

Location

Shinshu University Hospital

Matsumoto, 390 8621, Japan

Location

Saga University Hospital

Saga, 849-8501, Japan

Location

National Center for Child Health and Development

Setagaya Ku, 157 8535, Japan

Location

Tokyo Medical University Hospital

Shinjuku, 160 0023, Japan

Location

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, 569-8686, Japan

Location

Saiseikai Yokohamashi Tobu Hospital

Yokohama, 230-8765, Japan

Location

Akershus Universitetssykehus

Lørenskog, 1478, Norway

Location

Oslo University Hospital

Oslo, 0450, Norway

Location

Universitetssykehuset Nord-Norge HF

Tromsø, 9030, Norway

Location

St. Olavs Hospital

Trondheim, 7030, Norway

Location

Copernicus Podmiot Leczniczy Sp. z o.o

Gdansk, 80 803, Poland

Location

Korczowski Bartosz Gabinet Lekarski

Rzeszów, 35-302, Poland

Location

Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 04 501, Poland

Location

Instytut Pomnik Centrum Zdrowia Dziecka

Warsaw, 04 730, Poland

Location

Uls Santa Maria - Hosp. Santa Maria

Lisbon, 1649-035, Portugal

Location

Uls Santo Antonio - Cmin

Porto, 4050-651, Portugal

Location

Uls Sao Joao - Hosp. Sao Joao

Porto, 4200 319, Portugal

Location

Hosp. Infantil Univ. Nino Jesus

Madrid, 28009, Spain

Location

Corporacio Sanitari Parc Tauli

Sabadell, 08028, Spain

Location

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

Location

Gazi University Medical Faculty

Ankara, 06560, Turkey (Türkiye)

Location

Ankara University Medical Faculty

Ankara, 6620, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Marmara University Pendik Training Hospital

Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: January 19, 2024
• Primary Completion (Estimated): May 22, 2028
• Study Completion (Estimated): August 14, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3); AU (3); PL (4); NO (4); TU (4); IT (8); ES (3); PT (3); DK (2); CN (8); BE (4); FR (5); JP (10)