What this study is
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).
What's being tested
- Guselkumab
Intervention · DRUG
Guselkumab will be administered as subcutaneous injection.
Study details
- 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
- Sponsor
- Janssen Research & Development, LLC
- Conditions
- Crohns Disease · Colitis, Ulcerative · Arthritis, Psoriatic · Arthritis, Juvenile
- Enrolling
- 196 people
- Starts
- 2024-10-29
- Est. completion
- 2032-02-25
- Design
- Open-label, non-randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 3 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (53)
53 openEmory University
Atlanta, Georgia, United States
RecruitingChildren's Center for Digestive Healthcare
Atlanta, Georgia, United States
RecruitingRiley Hospital for Children
Indianapolis, Indiana, United States
RecruitingCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RecruitingCook Childrens Medical Center
Fort Worth, Texas, United States
RecruitingUniversity of Utah
Salt Lake City, Utah, United States
Recruiting
47 sites outside the US
Instituto Caici
Rosario, Argentina
RecruitingThe Kids Research Institute Australia on behalf of the Centre for Child Health Research
Nedlands, Australia
RecruitingMater Hospital Brisbane Inflammatory Bowel Diseases
South Brisbane, Australia
RecruitingThe Children's Hospital at Westmead
Westmead, Australia
RecruitingUZ Brussel
Jette, Belgium
RecruitingUniversitair Ziekenhuis Leuven
Leuven, Belgium
RecruitingHospital das Clinicas - UFG
Goiânia, Brazil
RecruitingINTEGRAL Pesquisa e Ensino
Votuporanga, Brazil
RecruitingCapital Center For Children's health Capital Medical University
Beijing, China
RecruitingChangzhou No 2 Peoples Hospital
Changzhou, China
RecruitingThe Childrens Hospital Zhejiang University School Of Medicine
Hangzhou, China
RecruitingSir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China
RecruitingRuijin Hospital Shanghai Jiao Tong University
Shanghai, China
RecruitingShengjing Hospital Of China Medical University
Shenyang, China
RecruitingHospital Center University De Lille
Lille, France
RecruitingSchon Klinik Hamburg Eilbek
Hamburg, Germany
RecruitingAsklepios Klinik Sankt Augustin
Sankt Augustin, Germany
RecruitingHadassah Ein-Qarem Medical Center
Jerusalem, Israel
RecruitingASST Papa Giovanni XXIII Bergamo
Bergamo, Italy
RecruitingAzienda USL di Bologna - Ospedale Maggiore
Bologna, Italy
RecruitingIRCCS Ospedale Pediatrico Bambino Gesu
Roma, Italy
RecruitingCasa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Italy
RecruitingIRCCS Materno Infantile Burlo Garofolo
Trieste, Italy
RecruitingTokyo Metropolitan Children's Medical Center
Fuchū, Japan
RecruitingKanazawa University Hospital
Kanazawa, Japan
RecruitingKobe University Hospital
Kobe, Japan
RecruitingJapanese Red Cross Kumamoto Hospital
Kumamoto, Japan
RecruitingShinshu University Hospital
Matsumoto, Japan
RecruitingSaga University Hospital
Saga, Japan
RecruitingYokohama City University Medical Center
Yokohama, Japan
RecruitingAkershus Universitetssykehus
Akershus, Norway
RecruitingKorczowski Bartosz Gabinet Lekarski
Rzeszów, Poland
RecruitingCentrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
Sosnowiec, Poland
RecruitingMedical Network
Warsaw, Poland
RecruitingInstytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland
RecruitingUls Braga - Hosp. Braga
Braga, Portugal
RecruitingUls Sao Joao - Hosp. Sao Joao
Porto, Portugal
RecruitingSeverance Hospital Yonsei University Health System
Seoul, South Korea
RecruitingSamsung Medical Center
Seoul, South Korea
RecruitingHosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain
RecruitingHosp. Univ. I Politecni La Fe
Valencia, Spain
RecruitingGazi University Medical Faculty
Ankara, Turkey (Türkiye)
RecruitingUmraniye Training and Research Hospital
Istanbul, Turkey (Türkiye)
RecruitingKocaeli Universitesi Hastanesi
Kocaeli, Turkey (Türkiye)
RecruitingSheffield Children's Hospital
Sheffield, United Kingdom
RecruitingRoyal Stoke University Hospital
Stoke-on-Trent, United Kingdom
RecruitingHaywood Hospital
Stoke-on-Trent, United Kingdom
Recruiting
Study team
Sponsor
Janssen Research & Development, LLC
Study ID CNTO1959ISD3001
Study director
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.