A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

NCT06663332 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: CNTO1959ISD30012023-509560-16-00
• Study Type: interventional
• Target: 196
• Locations: 14 countries
• Sites: 38

Brief Summary

The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).

Conditions

Crohns Disease; Colitis, Ulcerative; Arthritis, Psoriatic; Arthritis, Juvenile

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety

  Treatment-emergent adverse events will be reported to analyze the long-term safety of guselkumab in pediatric participants.

  Up to 6 years and 9 months

Study Arms (2)

Guselkumab (Every 8 weeks)

EXPERIMENTAL

Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 \[NCT06260163\], CNTO1959PBCRD3007 \[NCT05923073\], CNTO1275JPA3001 \[NCT05083182\]) will be enrolled in this long-term extension (LTE) study, if in investigator's opinion, participant will benefit from continued guselkumab therapy and will have continued access to guselkumab (every 8 weeks \[q8w\]). Participants coming from double-blinded arm of primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q8w dosing. Based on investigator's discretion and participant's clinical status, they have option to switch to q4w once during LTE study prior to unblinding of primary study assignment. Once the primary study is unblinded, dosing frequency may be adjusted to match what the participant had received before enrolling in LTE study. Participants coming from study CNTO1275JPA3001 will continue same dosing regimen from primary study (q8w) and cannot change their dosing interval during LTE study.

Drug: Guselkumab

Guselkumab (Every 4 weeks)

EXPERIMENTAL

Participants treated with guselkumab in one of the three primary studies (CNTO1959PUC3001 \[NCT06260163\], CNTO1959PBCRD3007 \[NCT05923073\], CNTO1275JPA3001 \[NCT05083182\]) will be enrolled in this LTE study, if in the investigator's opinion, the participant will benefit from continued guselkumab therapy. Participants will have continued access to guselkumab (q4w). Participants coming from the open-label arm of the primary studies CNTO1959PUC3001 and CNTO1959PBCRD3007 will be assigned to q4w dosing. No dose adjustments are permitted. Participants coming from the jPsA primary study (CNTO1275JPA3001) will continue the same dosing regimen from the primary study (q4w) and cannot change their dosing interval during the LTE study.

Drug: Guselkumab

Interventions

Guselkumab DRUG

Guselkumab will be administered as subcutaneous injection.

Also known as: CNTO1959

Guselkumab (Every 4 weeks); Guselkumab (Every 8 weeks)

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have completed the dosing planned in the primary pediatric guselkumab study
• Must have received benefit from continued guselkumab therapy in the opinion of the investigator
• Before enrollment, a participant must be either: (a) Not of childbearing potential, OR (b) Of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after the last dose - the end of relevant systemic exposure
• Parent(s) (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is required from participants who are capable of understanding the nature of the study, typically those aged 7 years and older, to ensure their willingness to participate. An adolescent who provides assent will have the opportunity to sign an adult ICF upon reaching the age of majority, thereby affirming their understanding of the study's purpose and procedures, as well as their willingness to participate.

You may not qualify if:

• Participant is greater than or equal to (\>=) 18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication
• Participant is \<18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication
• Are pregnant, nursing, or planning pregnancy or fathering a child
• Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention
• Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (38)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84113, United States

RECRUITING

Instituto Caici

Rosario, S2003CVB, Argentina

RECRUITING

Mater Hospital Brisbane Inflammatory Bowel Diseases

South Brisbane, 4101, Australia

RECRUITING

Capital Center For Children's health Capital Medical University

Beijing, 100020, China

RECRUITING

Changzhou No 2 Peoples Hospital

Changzhou, 213003, China

RECRUITING

The Childrens Hospital Zhejiang University School Of Medicine

Hangzhou, 310005, China

RECRUITING

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310016, China

RECRUITING

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, 200025, China

RECRUITING

Shengjing Hospital Of China Medical University

Shenyang, 110055, China

RECRUITING

Hospital Center University De Lille

Lille, 59000, France

RECRUITING

Schon Klinik Hamburg Eilbek

Hamburg, 22081, Germany

RECRUITING

Asklepios Klinik Sankt Augustin

Sankt Augustin, 53757, Germany

RECRUITING

ASST Papa Giovanni XXIII Bergamo

Bergamo, 24127, Italy

RECRUITING

Azienda USL di Bologna - Ospedale Maggiore

Bologna, 40121, Italy

RECRUITING

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, 00165, Italy

RECRUITING

IRCCS Materno Infantile Burlo Garofolo

Trieste, 34137, Italy

RECRUITING

Tokyo Metropolitan Children's Medical Center

Fuchū, 183 8561, Japan

RECRUITING

Kanazawa University Hospital

Kanazawa, 920 8641, Japan

RECRUITING

Kobe University Hospital

Kobe, 650 0017, Japan

RECRUITING

Japanese Red Cross Kumamoto Hospital

Kumamoto, 861 8520, Japan

RECRUITING

Shinshu University Hospital

Matsumoto, 390 8621, Japan

RECRUITING

Saga University Hospital

Saga, 849 0937, Japan

RECRUITING

Yokohama City University Medical Center

Yokohama, 232 0024, Japan

RECRUITING

Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o

Sosnowiec, 41 200, Poland

RECRUITING

Medical Network

Warsaw, 04-501, Poland

RECRUITING

Instytut Pomnik Centrum Zdrowia Dziecka

Warsaw, 04-730, Poland

RECRUITING

Uls Braga - Hosp. Braga

Braga, 4710 243, Portugal

RECRUITING

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

RECRUITING

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

RECRUITING

Gazi University Medical Faculty

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Umraniye Training and Research Hospital

Istanbul, 34764, Turkey (Türkiye)

RECRUITING

Kocaeli Universitesi Hastanesi

Kocaeli, 41380, Turkey (Türkiye)

RECRUITING

Royal Stoke University Hospital

Stoke-on-Trent, ST4 6QG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Arthritis, Psoriatic; Arthritis, Juvenile

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 29, 2024
• Study Start: October 29, 2024
• Primary Completion (Estimated): December 12, 2031
• Study Completion (Estimated): December 12, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (2); DE (2); AU (1); PT (1); ES (2); JP (7); FR (1); TU (3); GB (1); IT (4); US (4); PL (3); AR (1); CN (6)