Novartis Pharmaceuticals
The purpose of this Phase 2a/b study is: 1. to evaluate the efficacy, safety and tolerability of DDY391 in participants with psoriatic arthritis (PsA). 2. to determine the dose-response relationship of DDY391 in participants with PsA to support dose selection for Phase 3.
This study is a Phase 2a/b, randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy, safety, tolerability and dose-response relationship of DDY391 in participants with active moderate to severe PsA. The study is composed of two sequential parts: * Part A to evaluate efficacy, safety and tolerability of DDY391 compared with placebo. * Part B to determine the dose-response relationship of multiple doses of DDY391 compared with placebo.
Key Inclusion Criteria: * Female or male participants at least 18 years of age. * Diagnosis of PsA and meeting classification criteria for Psoriatic arthritis (CASPAR) at screening. * Moderate to severe PsA at screening and baseline. Key Exclusion Criteria: * Presence of inflammatory conditions other than psoriasis or PsA including but not limited to those associated with arthralgia or arthritis (e.g., rheumatoid arthritis, systemic lupus erythematosus, scleroderma, sarcoidosis) or presence of fibromyalgia or osteoarthritis with articular symptoms. * Use of bDMARD treatment within 4 weeks o…
DDY391
Matching placebo
Arctuva estimate
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