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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

Full criteria on ClinicalTrials.gov

Sites (58)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto CAICI
Coordinator of this site? Confirm its status
RosarioArgentinaRecruiting
The Kids Research Institute Australia on behalf of the Centre for Child Health Research
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NedlandsAustraliaRecruiting
Mater Hospital Brisbane Inflammatory Bowel Diseases
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South BrisbaneAustraliaRecruiting
The Children's Hospital at Westmead
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WestmeadAustraliaRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
UZ Brussel
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JetteBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Hospital das Clinicas - UFG
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GoiâniaBrazilRecruiting
Integral Pesquisa e Ensino
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VotuporangaBrazilRecruiting
Capital Center For Children's health Capital Medical University
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BeijingChinaRecruiting
Changzhou No 2 Peoples Hospital
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ChangzhouChinaRecruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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HangzhouChinaRecruiting
The Childrens Hospital, Zhejiang University School of Medicine
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HangzhouChinaRecruiting
Ruijin Hospital Shanghai Jiao Tong University
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ShanghaiChinaRecruiting
Shengjing Hospital Of China Medical University
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ShenyangChinaRecruiting
Hamburger Zentrum für Kinder- und Jugendrheumatologie -
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HamburgGermanyRecruiting
Asklepios-Klinik, Sankt Augustin GmbH
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Sankt AugustinGermanyRecruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Sheffield Children's Hospital
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SheffieldUnited KingdomRecruiting
Royal Stoke University Hospital
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Stoke-on-TrentUnited KingdomRecruiting
Haywood Hospital
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Stoke-on-TrentUnited KingdomRecruiting
Hadassah Ein-Qarem Medical Center
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JerusalemIsraelRecruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyRecruiting
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyRecruiting
Ospedale Pediatrico Bambino Gesù
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RomeItalyRecruiting
Casa Sollievo della Sofferenza
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San Giovanni RotondoItalyRecruiting
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
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TriesteItalyRecruiting
Tokyo Metropolitan Children's Medical Center
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FuchūJapanRecruiting
Kanazawa University Hospital
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KanazawaJapanRecruiting
Kobe University Hospital
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KobeJapanRecruiting
Japanese Red Cross Kumamoto Hospital
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KumamotoJapanRecruiting
Shinshu University Hospital
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MatsumotoJapanRecruiting
Saga University Hospital
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SagaJapanRecruiting
Yokohama City University Medical Center
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YokohamaJapanRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Akershus University Hospital
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LoerenskogNorwayRecruiting
Oslo Universitetssykehus HF
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OsloNorwayRecruiting
Universitetssykehuset Nord-Norge HF
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TromsoeNorwayRecruiting
Korczowski Bartosz, Gabinet Lekarski
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RzeszówPolandRecruiting
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
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SosnowiecPolandRecruiting
Medical Network Sp z o o
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WarsawPolandRecruiting
Instytut Pomnik Centrum Zdrowia Dziecka
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WarsawPolandRecruiting
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
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WarsawPolandRecruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalRecruiting
Unidade Local de Saude de Sao Joao E.P.E.
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PortoPortugalRecruiting
Emory University
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AtlantaUnited StatesRecruiting
Children's Center for Digestive Healthcare
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AtlantaUnited StatesRecruiting
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesRecruiting
Cook Childrens Medical Center
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Fort WorthUnited StatesRecruiting
Riley Hospital for Children
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IndianapolisUnited StatesRecruiting
University of Utah
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Salt Lake CityUnited StatesRecruiting
Gazi University Medical Faculty
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AnkaraTurkey (Türkiye)Recruiting
Ümraniye Training and Research Hospital
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IstanbulTurkey (Türkiye)Recruiting
Kocaeli Universitesi Hastanesi
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KocaeliTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.