A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
NCT ID: NCT06663332
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
196 participants
INTERVENTIONAL
2024-10-29
2031-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Guselkumab (Every 8 weeks)
Participants 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.
Guselkumab
Guselkumab will be administered as subcutaneous injection.
Guselkumab (Every 4 weeks)
Participants 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.
Guselkumab
Guselkumab will be administered as subcutaneous injection.
Interventions
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Guselkumab
Guselkumab will be administered as subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 \<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
3 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Riley Hospital for Children
Indianapolis, Indiana, United States
University of Utah
Salt Lake City, Utah, United States
Instituto Caici
Rosario, , Argentina
Capital Center For Children's health Capital Medical University
Beijing, , China
Changzhou No 2 Peoples Hospital
Changzhou, , China
The Childrens Hospital Zhejiang University School Of Medicine
Hangzhou, , China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, , China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, , China
Shengjing Hospital Of China Medical University
Shenyang, , China
Schon Klinik Hamburg Eilbek
Hamburg, , Germany
Kanazawa University Hospital
Kanazawa, , Japan
Kobe University Hospital
Kobe, , Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, , Japan
Saga University Hospital
Saga, , Japan
Medical Network
Warsaw, , Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, , Poland
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, , Spain
Gazi University Medical Faculty
Ankara, , Turkey (Türkiye)
Umraniye Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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CNTO1959ISD3001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509560-16-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CNTO1959ISD3001
Identifier Type: -
Identifier Source: org_study_id