Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
- Conditions
- Juvenile psoriatic arthritisTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2023-507144-36-00
- Lead Sponsor
- Janssen - Cilag International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 58
=5 to <18 years of age, inclusive., Diagnosis of jPsA by Vancouver inclusion criteria, with exclusion of ERA. Diagnosis made =3 months (ie. 90 days) prior to screening. Arthritis plus psoriasis, or arthritis plus =2 of the following: dactylitis, nail pits, family history of psoriasis in a first- or second-degree relative, psoriasis-like rash., 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, Have active disease despite previous non-biologic DMARD and/or 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., If previously treated with an anti-TNFa agent (such as adalimumab, etanercept, infliximab, golimumab [SC or IV], certolizumab pegol, or their respective biosimilars) or other biologic agents that are not included in the exclusion criteria, these agents should have been discontinued taking into consideration their elimination half-life, dosing frequency and acceptable clinical practice, before first study intervention administration (see Appendix 7 [Section 10.7] for Table 7 with the required minimal washout period for a specific prior treatment). Refer to Appendix 18 (Section 10.18.1) for country-specific requirements in France for the required minimum washout periods for Anti-TNFa agents.
Participants with enthesitis-related arthritis (ERA; see definition in Appendix 17 of the study protocol), Taken any disallowed therapies as noted in Section 6.8, Concomitant Therapy within the timeframe specified before the planned first dose of study intervention., If participants were non-responders to previously received IL-23 blockers including guselkumab, 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. Participants who previously discontinued ustekinumab for intolerance or inadequate response may be enrolled into the guselkumab cohort. Patients who previously discontinued guselkumab due to intolerance may be enrolled into the ustekinumab cohort. Participants who previously discontinued tildrakizumab or risankizumab due to intolerance may be enrolled into either cohort., Has other inflammatory disease that might confound the evaluation of benefit from ustekinumab or guselkumab therapy, including but not limited to moderate to severe inflammatory bowel disease, systemic lupus erythematosus, or Lyme disease., Has active uveitis within 12 weeks prior to screening or during screening, prior to the first administration of study intervention.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method