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.
None
Presence of another autoimmune rheumatic disease that is active at screening and constitutes the principal illness.
Participants taking > 400 mg/day hydroxychloroquine are excluded. Participants taking ≤400 mg/day hydroxychloroquine should be on a stable dose for at least 4 weeks prior to randomization.
Participants taking > 400 mg/day hydroxychloroquine are excluded. Participants on ≤ 400 mg/day of hydroxychloroquine should be on a stable dose for at least 4 weeks prior to randomization.
Prior treatment with any of the following within 3 months prior to randomization: belimumab, abatacept, anti-tumor necrosis factor alpha biologic agents, immunoglobulins, plasmapheresis, intravenous (i.v.) or oral cyclophosphamide, mycophenolate mofetil, i.v. or oral cyclosporine A, or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors, IL-2, anti-IL-6, anti-IL-17).
8
Treatment groupsSee each treatment group below.