A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06663332
Phase
PHASE3
Status
Recruiting
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Conditions

  • Arthritis, Juvenile
  • Arthritis, Psoriatic
  • Colitis, Ulcerative
  • Crohns Disease

Eligibility Criteria

Sex
ALL
Age
3 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    Guselkumab will be administered as subcutaneous injection.

Study Details

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).

Key Dates

Start date
Oct 29, 2024
Status verified
Jun 2026
Primary completion
Dec 12, 2031
Completion
Feb 25, 2032

Study Design

Enrollment
196 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety [ Time Frame: Up to 6 years and 9 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Children's Center for Digestive HealthcareAtlantaGeorgia30342-
Emory UniversityAtlantaGeorgia30322-
Riley Hospital for ChildrenIndianapolisIndiana46202-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
University of UtahSalt Lake CityUtah84113-

Find similar trials in Atlanta, GA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Children's Center for Digestive Healthcare· Atlanta, GAEmory University· Atlanta, GARiley Hospital for Children· Indianapolis, INCincinnati Children's Hospital Medical Center· Cincinnati, OHUniversity of Utah· Salt Lake City, UT

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