NCT06663332RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 196 (estimated)
- First submitted
- 28 Oct 2024
- Start date
- 29 Oct 2024
- Primary completion date
- 12 Dec 2031
- Lead sponsor
- Janssen Research & Development, LLC
- NCT number
- NCT06663332
- EU CT number
- 2023-509560-16-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 196
- From 29 Oct 2024 to the primary completion date, 12 Dec 2031
- 58 sites in 18 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention
Other illness
- 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
Age
- 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
Other
- Are pregnant, nursing, or planning pregnancy or fathering a child
- 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
Who the study is looking for
- 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.
Age in the registry: 3 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (58)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto CAICI Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| The Kids Research Institute Australia on behalf of the Centre for Child Health Research Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| Mater Hospital Brisbane Inflammatory Bowel Diseases Coordinator of this site? Confirm its status | South Brisbane | Australia | Recruiting |
| The Children's Hospital at Westmead Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Hospital das Clinicas - UFG Coordinator of this site? Confirm its status | Goiânia | Brazil | Recruiting |
| Integral Pesquisa e Ensino Coordinator of this site? Confirm its status | Votuporanga | Brazil | Recruiting |
| Capital Center For Children's health Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Changzhou No 2 Peoples Hospital Coordinator of this site? Confirm its status | Changzhou | China | Recruiting |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The Childrens Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Ruijin Hospital Shanghai Jiao Tong University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| Hamburger Zentrum für Kinder- und Jugendrheumatologie - Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Asklepios-Klinik, Sankt Augustin GmbH Coordinator of this site? Confirm its status | Sankt Augustin | Germany | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Sheffield Children's Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Royal Stoke University Hospital Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Recruiting |
| Haywood Hospital Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Recruiting |
| Hadassah Ein-Qarem Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Recruiting |
| Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo Coordinator of this site? Confirm its status | Trieste | Italy | Recruiting |
| Tokyo Metropolitan Children's Medical Center Coordinator of this site? Confirm its status | Fuchū | Japan | Recruiting |
| Kanazawa University Hospital Coordinator of this site? Confirm its status | Kanazawa | Japan | Recruiting |
| Kobe University Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Recruiting |
| Japanese Red Cross Kumamoto Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Recruiting |
| Shinshu University Hospital Coordinator of this site? Confirm its status | Matsumoto | Japan | Recruiting |
| Saga University Hospital Coordinator of this site? Confirm its status | Saga | Japan | Recruiting |
| Yokohama City University Medical Center Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Akershus University Hospital Coordinator of this site? Confirm its status | Loerenskog | Norway | Recruiting |
| Oslo Universitetssykehus HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Universitetssykehuset Nord-Norge HF Coordinator of this site? Confirm its status | Tromsoe | Norway | Recruiting |
| Korczowski Bartosz, Gabinet Lekarski Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o Coordinator of this site? Confirm its status | Sosnowiec | Poland | Recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Instytut Pomnik Centrum Zdrowia Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Recruiting |
| Unidade Local de Saude de Sao Joao E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Children's Center for Digestive Healthcare Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Cook Childrens Medical Center Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Riley Hospital for Children Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Gazi University Medical Faculty Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Ümraniye Training and Research Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Kocaeli Universitesi Hastanesi Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.