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Crohns DiseasePhase 3TRILOGYNCT06663332

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

A Phase 3 study testing Guselkumab in people with Crohns Disease and Colitis, Ulcerative, run by Janssen Research & Development, LLC at 53 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 3 years and older
What is being tested?
Guselkumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
53 sitesin 18 countries
Study dates
29 Oct 2024to 25 Feb 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

53 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

53 sites in 18 countries

Japan7 sites, 7 recruiting

  • Tokyo Metropolitan Children's Medical Center

    Fuchū, 183 8561

    Recruiting

  • Kanazawa University Hospital

    Kanazawa, 920 8641

    Recruiting

  • Kobe University Hospital

    Kobe, 650 0017

    Recruiting

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861 8520

    Recruiting

  • Shinshu University Hospital

    Matsumoto, 390 8621

    Recruiting

  • Saga University Hospital

    Saga, 849 0937

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, 232 0024

    Recruiting

Other trials in Japan

United States6 sites, 6 recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • Children's Center for Digestive Healthcare

    Atlanta, Georgia, 30342

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Recruiting

  • Cook Childrens Medical Center

    Fort Worth, Texas, 76104

    Recruiting

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84113

    Recruiting

Other trials in United States

China6 sites, 6 recruiting

  • Capital Center For Children's health Capital Medical University

    Beijing, 100020

    Recruiting

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213003

    Recruiting

  • The Childrens Hospital Zhejiang University School Of Medicine

    Hangzhou, 310005

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

    Recruiting

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025

    Recruiting

  • Shengjing Hospital Of China Medical University

    Shenyang, 110055

    Recruiting

Other trials in China

Italy5 sites, 5 recruiting

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo, 24127

    Recruiting

  • Azienda USL di Bologna - Ospedale Maggiore

    Bologna, 40121

    Recruiting

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165

    Recruiting

  • Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, 71013

    Recruiting

  • IRCCS Materno Infantile Burlo Garofolo

    Trieste, 34137

    Recruiting

Other trials in Italy

Poland4 sites, 4 recruiting

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszów, 35-302

    Recruiting

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

    Sosnowiec, 41 200

    Recruiting

  • Medical Network

    Warsaw, 04-501

    Recruiting

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04-730

    Recruiting

Other trials in Poland

Australia3 sites, 3 recruiting

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

    Nedlands, 6009

    Recruiting

  • Mater Hospital Brisbane Inflammatory Bowel Diseases

    South Brisbane, 4101

    Recruiting

  • The Children's Hospital at Westmead

    Westmead, 2145

    Recruiting

Other trials in Australia

Turkey (Türkiye)3 sites, 3 recruiting

  • Gazi University Medical Faculty

    Ankara, 06560

    Recruiting

  • Umraniye Training and Research Hospital

    Istanbul, 34764

    Recruiting

  • Kocaeli Universitesi Hastanesi

    Kocaeli, 41380

    Recruiting

Other trials in Turkey (Türkiye)

United Kingdom3 sites, 3 recruiting

  • Sheffield Children's Hospital

    Sheffield, S10 2TH

    Recruiting

  • Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG

    Recruiting

  • Haywood Hospital

    Stoke-on-Trent, ST6 7AG

    Recruiting

Other trials in United Kingdom

Belgium2 sites, 2 recruiting

  • UZ Brussel

    Jette, 1090

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Recruiting

Other trials in Belgium

Brazil2 sites, 2 recruiting

  • Hospital das Clinicas - UFG

    Goiânia, 74605 020

    Recruiting

  • INTEGRAL Pesquisa e Ensino

    Votuporanga, 15500-269

    Recruiting

Other trials in Brazil

Germany2 sites, 2 recruiting

  • Schon Klinik Hamburg Eilbek

    Hamburg, 22081

    Recruiting

  • Asklepios Klinik Sankt Augustin

    Sankt Augustin, 53757

    Recruiting

Other trials in Germany

Portugal2 sites, 2 recruiting

  • Uls Braga - Hosp. Braga

    Braga, 4710 243

    Recruiting

  • Uls Sao Joao - Hosp. Sao Joao

    Porto, 4200 319

    Recruiting

Other trials in Portugal

South Korea2 sites, 2 recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

Other trials in South Korea

Spain2 sites, 2 recruiting

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

    Recruiting

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

    Recruiting

Other trials in Spain

Argentina1 site, 1 recruiting

  • Instituto Caici

    Rosario, S2003CVB

    Recruiting

Other trials in Argentina

France1 site, 1 recruiting

  • Hospital Center University De Lille

    Lille, 59000

    Recruiting

Other trials in France

Israel1 site, 1 recruiting

  • Hadassah Ein-Qarem Medical Center

    Jerusalem, 5251108

    Recruiting

Other trials in Israel

Norway1 site, 1 recruiting

  • Akershus Universitetssykehus

    Akershus, 1478

    Recruiting

Other trials in Norway

About this study

Official title: 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).

Being tested
Guselkumab
Medical subject headings
Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GuselkumabDrug

    Also called CNTO1959

    Guselkumab will be administered as subcutaneous injection.

Study groups in NCT06663332
Study groupRoleWhat they receive
Guselkumab (Every 8 weeks)ExperimentalParticipants 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.
Receives: Drug: Guselkumab
Guselkumab (Every 4 weeks)ExperimentalParticipants 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.
Receives: Drug: Guselkumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 6 years and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2024
  2. Study start29 Oct 2024
  3. Primary completion12 Dec 2031 (estimated)
  4. Study completion25 Feb 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
196 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06663332
Sponsor's protocol ID
CNTO1959ISD3001
Other IDs
CNTO1959ISD3001, 2023-509560-16-00, 2023
Acronym
TRILOGY
Status last verified
Nov 2026
First submitted
28 Oct 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Guselkumab in people with Crohns Disease and Colitis, Ulcerative, run by Janssen Research & Development, LLC at 53 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Japan, United States, China, Italy, Poland and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety (time frame: Up to 6 years and 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06663332.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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