Novartis Pharmaceuticals
To evaluate efficacy, safety, and tolerability of DDY391 up to 52 weeks in participants with Sjögren's disease (SjD) and to determine the dose response relationship of DDY391 in participants with SjD, to support dose selection for Phase 3.
This study is a Phase 2a/b, randomized, double-blind, placebo-controlled, multi-center trial involving participants with SjD. The study consists of three parts (Part A, Part B, and Part C). The study includes a screening period of up to 8 weeks to assess eligibility, a 52-week treatment period, and a 4-week safety follow-up period after the last dose of study treatment.
Key Inclusion Criteria: • Participants must have a diagnosis of SjD according to the ACR/EULAR 2016 classification criteria at screening: \- Positive anti-Ro (SSA) antibodies at screening. Participants negative for anti-Ro/SSA antibodies are eligible if they have documented previous biopsy showing evidence of salivary gland inflammation consistent with SjD. Key Exclusion Criteria: * Presence of another autoimmune rheumatic disease that is active at screening and constitutes the principal illness. * Exclusion based on medications being used for SjD: * Participants taking \> 400 mg/day hy…
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3
Matching Placebo