Juvenile Psoriatic Arthritis MedDRA version: 20.0 Level: PT Classification code 10076674 Term: Juvenile psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =5 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Participants with enthesitis-related arthritis (ERA) 2. Taken any disallowed therapies as noted in Section 6.8, Concomitant Therapy of the study protocol before the planned first dose of study intervention. 3. If participants were nonresponders to previously received biologic treatment (excluding anti TNFas), including, but not limited to, guselkumab, secukinumab (AIN457), tildrakizumab (MK3222), ixekizumab (LY2439821), brodalumab (AMG827), risankizumab (BI-655066), or other investigative biologic treatments for PsA or psoriasis. Prior nonresponse to an anti-TNFa inhibitor or to a Janus kinase (JAK) inhibitor is not an exclusion. 4. Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 4 months before the planned first dose of study intervention or is currently enrolled in an investigational study. Receipt of an investigational vaccine for COVID-19 is not an automatic exclusion criterion; discuss with medical monitor. 5. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening. An exception is made for participants currently receiving treatment for latent TB with no evidence of active TB, or who have a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of study agent (Section 5.1, Inclusion criterion 16.a of the study protocol).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Evaluate PK of ustekinumab in jPsA - Evaluate efficacy of ustekinumab in jPsA;Secondary Objective: - Evaluate PK of ustekinumab in jPsA - Evaluate efficacy of ustekinumab in jPsA - Evaluate safety of ustekinumab in jPsA - Evaluate immunogenicity of ustekinumab in jPsA;Primary end point(s): 1. Observed steady-state trough concentrations and population PK model-predicted area under the curve at steady-state over a 12-week dosing interval (AUCss) at Week 28. 2. Percentage of participants with jPsA achieving the JIA ACR 30 criteria at Week 24.;Timepoint(s) of evaluation of this end point: 1: Week 28 2: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PK 1. Observed steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 52. Efficacy 2. Proportions of participants with JIA ACR 30 response at baseline and Weeks 4, 8, 12, 16, and 52. 3. Proportions of participants with JIA ACR 50 and 70 responses at baseline and Weeks 4, 8, 12, 16, 24, and 52. 4. Time to response measured using JIA ACR 30 from baseline through Week 24. 5. Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS) at Weeks 4, 8, 12, 16, 28, and 52. 6. Change from baseline in Psoriasis Area Severity Index (PASI) at Week 24. Safety 7. The occurrences and type of AEs, serious adverse events (SAEs), and reasonably related AEs including injection-site reactions and infections will be summarized. 8. The number of participants with abnormal laboratory parameters (hematology and chemistry) based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) toxicity grading will be summarized. Immunogenicity 9. The overall incidence of antibodies to ustekinumab (including peak titers) through Week 68.;Timepoint(s) of evaluation of this end point: 1: Week 52 2: baseline and Weeks 4, 8, 12, 16, and 52 3: baseline and Weeks 4, 8, 12, 16, 24, and 52 4: from baseline through Week 24 5: Weeks 4, 8, 12, 16, 28, and 52 6: Week 24 7, 8, 9: from baseline through Week 68 | — |
Countries
Argentina, France, Germany, Italy, Russian Federation, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed