Juvenile Psoriatic Arthritis Skin and Connective Tissue Diseases
Conditions
Interventions
Cohort 1: Ustekinumab
Participants will receive a weight-based dose of Ustekinumab at Week 0, Week 4 and then every 12 weeks up to Week 52.
Ustekinumab will be administered by subcutaneous (SC) inject
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 5 to 18 years of age, inclusive. 2. Diagnosis of jPsA by Vancouver inclusion criteria, with exclusion of ERA. Diagnosis made =12 weeks prior to screening. Arthritis plus psoriasis, or arthritis plus =2 of the following: dactylitis, nail pits, family history of psioriasis in a first or second-degree relative, psoriasis-like rash. 3. Active disease in =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 4. Medically stable on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant’s source documents and initialed by the investigator. 5. Medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to not be clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator.
Exclusion criteria
Exclusion criteria: 1. Participants with enthesitis-related arthritis (ERA) 2. Taken any disallowed therapies as noted in Section 6.8, Concomitant Therapy within the timeframe specified before the planned first dose of study intervention. 3. If participants were non-responders to previously received biologic treatment with an overlapping mechanism including guselkumab, ustekinumab, tildrakizumab (MK3222) and risankizumab (BI-655066). Prior non-response to an anti-TNFa inhibitor, an IL-17 inhibitor or a Janus kinase (JAK) inhibitor is not an exclusion. Patients who previously discontinued ustekinumab for intolerance may be enrolled into the guselkumab cohort. Patients who previously discontinued guselkumab due to intolerance may be enrolled into the ustekinumab cohort. 4. Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 4 weeks or 5 half-lives (whichever is longer) before the planned first dose of either 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, 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 either study intervention (Section 5.1, Inclusion criterion 16.a of the study protocol).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ustekinumab 1. Observed steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 28 by baseline age groups. 2. Percentage of participants with jPsA achieving ACR Pedi 30 response at Week 24. Guselkumab 1. Observed 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. 2. Percentage of participants with jPsA achieving ACR Pedi 30 response at Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| PK Ustekinumab 1. Observed steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 52 by baseline age groups Guselkumab 1. Observed 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 2. Proportions of participants achieving ACR Pedi 30 response at Weeks 4, 8, 12, 16, 24 and 52. 3. Proportions of participants achieving ACR Pedi 50 and 70 responses at Weeks 4, 8, 12, 16, 24, and 52. 4. Time to response measured as time to achieving ACR Pedi 30 from baseline through Week 24. 5. Change from baseline in cJADAS 10, JADAS 10, 27, and 71 at Weeks 4, 8, 12, 16, 24, 28 and 52. 6. PASI response between baseline and Week 24. Guselkumab 2. Proportions of participants achieving ACR Pedi 30 response at Weeks 4, 8, 12, 16, 24, and 52. 3. Proportions of participants achieving ACR Pedi 50 and 70 responses at Weeks 4, 8, 12, 16, 24, and 52. 4. Time to response measured as time to achieving ACR Pedi 30 from baseline through Week 24. 5. Change from baseline in cJADAS 10, JADAS 10, 27, and 71 at Weeks 4, 8, 12, 16, 24, 28 and 52. 6. PASI response between baseline and Week 24. Safety Ustekinumab and Guselkumab 7. The occurrences and type of AEs, SAEs, and reasonably related AEs will be summarized. Immunogenicity Ustekinumab and Guselkumab 8. The overall incidence of antibodies to ustekinumab/guselkumab (including peak titers) through Week 68. | — |
Countries
Argentina, Belgium, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, Turkey, United Kingdom
Outcome results
None listed