A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
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
- Crohns Disease
- Colitis, Ulcerative
- Arthritis, Psoriatic
- Arthritis, Juvenile
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 196
- Started
- 29 October 2024
- Main results due
- 12 December 2031
- Study sites
- 51
- Registry updated
- 25 September 2026
Can you take part?
- Aged 3 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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 sites(51)
Emory University
Atlanta, Georgia, United States
Recruiting
Children's Center for Digestive Healthcare
Atlanta, Georgia, United States
Recruiting
Riley Hospital for Children
Indianapolis, Indiana, United States
Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Recruiting
Cook Childrens Medical Center
Fort Worth, Texas, United States
Recruiting
University of Utah
Salt Lake City, Utah, United States
Recruiting
Instituto Caici
Rosario, Argentina
Recruiting
The Kids Research Institute Australia on behalf of the Centre for Child Health Research
Nedlands, Australia
Recruiting
Mater Hospital Brisbane Inflammatory Bowel Diseases
South Brisbane, Australia
Recruiting
The Children's Hospital at Westmead
Westmead, Australia
Recruiting
Universitair Ziekenhuis Leuven
Leuven, Belgium
Recruiting
Hospital das Clinicas - UFG
Goiânia, Brazil
Recruiting
INTEGRAL Pesquisa e Ensino
Votuporanga, Brazil
Recruiting
Capital Center For Children's health Capital Medical University
Beijing, China
Recruiting
Changzhou No 2 Peoples Hospital
Changzhou, China
Recruiting
The Childrens Hospital Zhejiang University School Of Medicine
Hangzhou, China
Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China
Recruiting
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, China
Recruiting
Shengjing Hospital Of China Medical University
Shenyang, China
Recruiting
Hospital Center University De Lille
Lille, France
Recruiting
Schon Klinik Hamburg Eilbek
Hamburg, Germany
Recruiting
Asklepios Klinik Sankt Augustin
Sankt Augustin, Germany
Recruiting
ASST Papa Giovanni XXIII Bergamo
Bergamo, Italy
Recruiting
Azienda USL di Bologna - Ospedale Maggiore
Bologna, Italy
Recruiting
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, Italy
Recruiting
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Italy
Recruiting
IRCCS Materno Infantile Burlo Garofolo
Trieste, Italy
Recruiting
Tokyo Metropolitan Children's Medical Center
Fuchū, Japan
Recruiting
Kanazawa University Hospital
Kanazawa, Japan
Recruiting
Kobe University Hospital
Kobe, Japan
Recruiting
Japanese Red Cross Kumamoto Hospital
Kumamoto, Japan
Recruiting
Shinshu University Hospital
Matsumoto, Japan
Recruiting
Saga University Hospital
Saga, Japan
Recruiting
Yokohama City University Medical Center
Yokohama, Japan
Recruiting
Akershus Universitetssykehus
Akershus, Norway
Recruiting
Korczowski Bartosz Gabinet Lekarski
Rzeszów, Poland
Recruiting
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
Sosnowiec, Poland
Recruiting
Medical Network
Warsaw, Poland
Recruiting
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland
Recruiting
Uls Braga - Hosp. Braga
Braga, Portugal
Recruiting
Uls Sao Joao - Hosp. Sao Joao
Porto, Portugal
Recruiting
Severance Hospital Yonsei University Health System
Seoul, South Korea
Recruiting
Samsung Medical Center
Seoul, South Korea
Recruiting
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain
Recruiting
Hosp. Univ. I Politecni La Fe
Valencia, Spain
Recruiting
Gazi University Medical Faculty
Ankara, Turkey (Türkiye)
Recruiting
Umraniye Training and Research Hospital
Istanbul, Turkey (Türkiye)
Recruiting
Kocaeli Universitesi Hastanesi
Kocaeli, Turkey (Türkiye)
Recruiting
Sheffield Children's Hospital
Sheffield, United Kingdom
Recruiting
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
Recruiting
Haywood Hospital
Stoke-on-Trent, United Kingdom
Recruiting
Showing 51 of 51 sites. 51 of the 51 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06663332. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me