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)
概览
- 阶段
- 3 期
- 干预措施
- Ustekinumab
- 疾病 / 适应症
- Arthritis, Juvenile
- 发起方
- Janssen Research & Development, LLC
- 入组人数
- 50
- 试验地点
- 50
- 主要终点
- Cohort 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 28 by Baseline Age Groups
- 状态
- 进行中（未招募）
- 最后更新
- 19天前
概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jPsA).
研究者
入排标准
入选标准
- •Diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria with exclusion of enthesitis-related arthritis (ERA). Diagnosis made \>=3 months (that is, 90 days) prior to screening
- •Active disease in at least greater than or equal to (\>=) 3 joints at screening and at week 0 (defined as swelling or loss of motion with pain and/or tenderness. Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, loss of motion with pain or tenderness or both pain and tenderness meet the criteria for an active arthritic joint
- •Have active disease despite previous non-biologic disease modifying anti-rheumatic drug (DMARD) and/or non-steroidal anti-inflammatory drug (NSAID) therapy: Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 12 weeks or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance
- •Concurrent use of methotrexate, sulfasalazine, leflunomide, oral corticosteroids or NSAIDs is permitted but must be on stable dose
- •Participants must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed patients
- •Prior use of anti-TNFα agents, IL-17 inhibitors and other biologics (except non-responders to IL-23 inhibitors) and JAK inhibitors are permitted with sufficient washout period
排除标准
- •Participants with enthesitis-related arthritis (ERA)
- •Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis prior to screening
- •Have a history of, or ongoing, chronic or recurrent infectious disease
- •Has evidence of herpes zoster infection within 8 weeks prior to Week 0
- •Have a known history of hepatitis C infection or test positive at screening
研究组 & 干预措施
Cohort 1: Ustekinumab
Participants will receive a weight-based dose of ustekinumab subcutaneously (SC) at Week 0, Week 4 and then every 12 weeks up to Week 52. Cohort 1 is closed for further enrollment.
干预措施: Ustekinumab
Cohort 2: Guselkumab
The dose of guselkumab will be based on the participant's weight. Participants will receive guselkumab SC at Weeks 0 and 4 followed by either every 4 weeks (Q4W) (with historical radiographic evidence of joint damage) or every 8 weeks (Q8W) (without historical evidence of joint damage) dosing with the last dose at Week 52. Participants at high risk of joint damage can also be considered for Q4W dosing per investigator.
干预措施: Guselkumab
结局指标
主要结局
Cohort 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 28 by Baseline Age Groups
时间窗: Week 28
Steady-state trough serum concentration of ustekinumab at Week 28 by baseline age groups will be reported.
Cohort 2: Steady-state Trough Serum Concentration of Guselkumab at Week 28 by Baseline Age Groups
时间窗: Week 28
Steady-state trough serum concentration of guselkumab at Week 28 by baseline age groups will be reported.
Cohort 1: Area Under the Curve at Steady-state (AUCss) Over a 12-Week Dosing Interval of Ustekinumab at Week 28 by Baseline Age Groups
时间窗: Week 28
AUCss is defined as area under the curve at steady-state over a 12-week dosing interval of ustekinumab at Week 28 by baseline age groups.
Cohort 2: AUCss Over a Dosing Interval (4 or 8 Weeks) of Guselkumab at Week 28 by Baseline Age Groups
时间窗: Week 28
AUCss is defined as area under the curve at steady-state over a dosing interval (4 or 8 weeks) of guselkumab at Week 28 by baseline age groups.
Cohort 1: Percentage of Participants with Juvenile Psoriatic Arthritis (jPsA) Achieving American College of Rheumatology (ACR) Pediatric 30 Response at Week 24
时间窗: Week 24
Percentage of Participants with jPsA achieving ACR pediatric 30 response at Week 24 will be reported. The ACR pediatric 30 response criteria is defined as a 30 percent (%) improvement (that is, a decrease in score) from baseline in greater than or equal to (\>=) 3 of the following 6 components, with worsening of \>=30% in no more than 1 of the following components: physician global assessment (PGA) of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by childhood health assessment questionnaire (CHAQ) and C-reactive protein (CRP).
Cohort 2: Percentage of Participants with jPsA Achieving ACR Pediatric 30 Response at Week 24
时间窗: Week 24
Percentage of Participants with jPsA achieving ACR pediatric 30 response at Week 24 will be reported. The ACR pediatric 30 response criteria is defined as a 30% improvement (that is, a decrease in score) from baseline in \>=3 of the following 6 components, with worsening of \>=30% in no more than 1 of the following components: PGA of disease activity, patient/participant assessment of overall well-being, number of active joints (defined as swelling or loss of motion with pain and/or tenderness), number of joints with limited range of motion, physician function by CHAQ and CRP.
次要结局
- Cohorts 1: Steady-state Trough Serum Concentration of Ustekinumab at Week 52 by Baseline Age Groups(Week 52)
- Cohorts 2: Steady-state Trough Serum Concentration of Guselkumabat at Week 52 by Baseline Age Groups(Week 52)
- Cohort 1: AUCss Over a 12-Week Dosing Interval of Ustekinumab at Week 52 by Baseline Age Groups(Week 52)
- Cohort 2: AUCss Over a Dosing Interval (4 or 8 Weeks) of Guselkumab at Week 52 by Baseline Age Groups(Week 52)
- Cohorts 1 and 2: Percentage of Participants Achieving ACR Pediatric 30 Response at Weeks 4, 8, 12, 16, and 52(Weeks 4, 8, 12, 16 and 52)
- Cohorts 1 and 2: Percentage of Participants Achieving ACR Pediatric 50 and 70 Responses at Weeks 4, 8, 12, 16, 24, and 52(Weeks 4, 8, 12, 16, 24, and 52)
- Cohorts 1 and 2: Time to Response Measured as Time to Achieving ACR Pediatric 30(Baseline, up to Week 24)
- Cohorts 1 and 2: Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS) 10 at Weeks 4, 8, 12, 16, 24, and 52(Baseline, up to Weeks 4, 8, 12, 16, 24, and 52)
- Cohorts 1 and 2: Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) 10, 27 and 71 at Weeks 4, 8, 12, 16, 24, and 52(Baseline, up to Weeks 4, 8, 12, 16, 24, and 52)
- Cohorts 1 and 2: Change from Baseline in Psoriasis Area Severity Index (PASI) Score at Week 24(Baseline and Week 24)
- Cohorts 1 and 2: Percentage of Participants with Adverse Events (AEs)(Up to Week 68)
- Cohorts 1 and 2: Percentage of Participants with Serious Adverse Events (SAEs)(Up to Week 68)
- Cohorts 1 and 2: Percentage of Participants with Reasonably Related AEs(Up to Week 68)
- Cohorts 1: Number of Participants with Antibodies to Ustekinumab(Weeks 52 and 68)
- Cohorts 2 : Number of Participants with Antibodies to Guselkumab(Weeks 52 and 68)