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

November 2, 2026 updated by: Janssen Research & Development, LLC

CNTO1959ISD3001: A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study to Evaluate the Safety of Guselkumab in Pediatric Participants With Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

196

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Rosario, Argentina, S2003CVB
        • Recruiting
        • Instituto Caici
  • Australia
      • Nedlands, Australia, 6009
        • Recruiting
        • The Kids Research Institute Australia on behalf of the Centre for Child Health Research
      • South Brisbane, Australia, 4101
        • Recruiting
        • Mater Hospital Brisbane Inflammatory Bowel Diseases
      • Westmead, Australia, 2145
        • Recruiting
        • The Children's Hospital at Westmead
  • Belgium
      • Jette, Belgium, 1090
        • Recruiting
        • UZ Brussel
      • Leuven, Belgium, 3000
        • Recruiting
        • Universitair Ziekenhuis Leuven
  • Brazil
      • Goiânia, Brazil, 74605 020
        • Recruiting
        • Hospital das Clinicas - UFG
      • Votuporanga, Brazil, 15500-269
        • Recruiting
        • INTEGRAL Pesquisa e Ensino
  • China
      • Beijing, China, 100020
        • Recruiting
        • Capital Center For Children's health Capital Medical University
      • Changzhou, China, 213003
        • Recruiting
        • Changzhou No 2 Peoples Hospital
      • Hangzhou, China, 310005
        • Recruiting
        • The Childrens Hospital Zhejiang University School Of Medicine
      • Hangzhou, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital Shanghai Jiao Tong University
      • Shenyang, China, 110055
        • Recruiting
        • Shengjing Hospital Of China Medical University
  • France
      • Lille, France, 59000
        • Recruiting
        • Hospital Center University De Lille
  • Germany
      • Hamburg, Germany, 22081
        • Recruiting
        • Schon Klinik Hamburg Eilbek
      • Sankt Augustin, Germany, 53757
        • Recruiting
        • Asklepios Klinik Sankt Augustin
  • Israel
      • Jerusalem, Israel, 5251108
        • Recruiting
        • Hadassah Ein-Qarem Medical Center
  • Italy
      • Bergamo, Italy, 24127
        • Recruiting
        • ASST Papa Giovanni XXIII Bergamo
      • Bologna, Italy, 40121
        • Recruiting
        • Azienda USL di Bologna - Ospedale Maggiore
      • Roma, Italy, 00165
        • Recruiting
        • IRCCS Ospedale Pediatrico Bambino Gesu
      • San Giovanni Rotondo, Italy, 71013
        • Recruiting
        • Casa Sollievo Della Sofferenza IRCCS
      • Trieste, Italy, 34137
        • Recruiting
        • IRCCS Materno Infantile Burlo Garofolo
  • Japan
      • Fuchū, Japan, 183 8561
        • Recruiting
        • Tokyo Metropolitan Children's Medical Center
      • Kanazawa, Japan, 920 8641
        • Recruiting
        • Kanazawa University Hospital
      • Kobe, Japan, 650 0017
        • Recruiting
        • Kobe University Hospital
      • Kumamoto, Japan, 861 8520
        • Recruiting
        • Japanese Red Cross Kumamoto Hospital
      • Matsumoto, Japan, 390 8621
        • Recruiting
        • Shinshu University Hospital
      • Saga, Japan, 849 0937
        • Recruiting
        • Saga University Hospital
      • Yokohama, Japan, 232 0024
        • Recruiting
        • Yokohama City University Medical Center
  • Norway
      • Akershus, Norway, 1478
        • Recruiting
        • Akershus Universitetssykehus
  • Poland
      • Rzeszów, Poland, 35-302
        • Recruiting
        • Korczowski Bartosz Gabinet Lekarski
      • Sosnowiec, Poland, 41 200
        • Recruiting
        • Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
      • Warsaw, Poland, 04-730
        • Recruiting
        • Instytut Pomnik Centrum Zdrowia Dziecka
      • Warsaw, Poland, 04-501
        • Recruiting
        • Medical Network
  • Portugal
      • Braga, Portugal, 4710 243
        • Recruiting
        • Uls Braga - Hosp. Braga
      • Porto, Portugal, 4200 319
        • Recruiting
        • Uls Sao Joao - Hosp. Sao Joao
  • South Korea
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital Yonsei University Health System
  • Spain
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Hosp. Clinico Univ. de Santiago
      • Valencia, Spain, 46026
        • Recruiting
        • Hosp. Univ. I Politecni La Fe
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06560
        • Recruiting
        • Gazi University Medical Faculty
      • Istanbul, Turkey (Türkiye), 34764
        • Recruiting
        • Umraniye Training and Research Hospital
      • Kocaeli, Turkey (Türkiye), 41380
        • Recruiting
        • Kocaeli Universitesi Hastanesi
  • United Kingdom
      • Sheffield, United Kingdom, S10 2TH
        • Recruiting
        • Sheffield Children's Hospital
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Recruiting
        • Royal Stoke University Hospital
      • Stoke-on-Trent, United Kingdom, ST6 7AG
        • Recruiting
        • Haywood Hospital
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Children's Center for Digestive Healthcare
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Cook Childrens Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Recruiting
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guselkumab (Every 8 weeks)

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 will be administered as subcutaneous injection.

Other Names:
  • CNTO1959
Experimental: Guselkumab (Every 4 weeks)

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

Guselkumab will be administered as subcutaneous injection.

Other Names:
  • CNTO1959

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety
Time Frame: Up to 6 years and 9 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2024

Primary Completion (Estimated)

December 12, 2031

Study Completion (Estimated)

February 25, 2032

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

November 3, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNTO1959ISD3001
  • CNTO1959ISD3001 (Other Identifier: Janssen Research & Development, LLC)
  • 2023-509560-16-00 (Registry Identifier: EUCT number)
  • 2023 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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