A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)

Juvenile psoriatic arthritis

Ustekinumab Steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 28 by baseline age groups., Ustekinumab ACR Pedi 30 response at Week 24., Guselkumab Steady-state trough concentrations and population PK model-predicted AUCss over a dosing interval (4 or 8 weeks) at Week 28 by baseline age groups., Guselkumab ACR Pedi 30 response at Week 24.

PK – Ustekinumab Steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 52 by baseline age groups, PK – Guselkumab Steady-state trough concentrations and population PK model-predicted AUCss over a dosing interval (4 or 8 weeks) at Week 52 by baseline age groups., Efficacy – Ustekinumab ACR Pedi 30 response at Weeks 4, 8, 12, 16, and 52., Efficacy – Ustekinumab ACR Pedi 50 and 70 responses at Weeks 4, 8, 12, 16, 24, and 52., Efficacy – Ustekinumab Time to response measured as time to achieving ACR Pedi 30 from baseline through Week 24., Efficacy – Ustekinumab Change from baseline in cJADAS 10, JADAS 10, 27, and 71 at Weeks 4, 8, 12, 16, 24, and 52., Efficacy – Ustekinumab Change from baseline in PASI score at Week 24 among the participants with ≥3% BSA psoriatic involvement and a PGA psoriasis score of ≥2 (mild) at baseline., Efficacy – Guselkumab ACR Pedi 30 response at Weeks 4, 8, 12, 16, and 52., Efficacy – Guselkumab ACR Pedi 50 and 70 responses at Weeks 4, 8, 12, 16, 24, and 52., Efficacy – Guselkumab Time to response measured as time to achieving ACR Pedi 30 from baseline through Week 24., Efficacy – Guselkumab Change from baseline in cJADAS 10, JADAS 10, 27, and 71 at Weeks 4, 8, 12, 16, 24, and 52., Efficacy – Guselkumab Change from baseline in PASI score at Week 24 among the participants with ≥3% BSA psoriatic involvement and a PGA psoriasis score of ≥2 (mild) at baseline., Safety – Ustekinumab The occurrences and type of AEs, SAEs, and reasonably related AEs., Safety –Guselkumab The occurrences and type of AEs, SAEs, and reasonably related AEs., Immunogenicity – Ustekinumab The incidence of antibodies to ustekinumab/guselkumab (including peak titers) through Week 52 and Week 68., Immunogenicity –Guselkumab The incidence of antibodies to ustekinumab/guselkumab (including peak titers) through Week 52 and Week 68.

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