This is a Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of IMVT-1402 in adult participants with moderate to severe systemic primary Sjogren's disease (SjD).
Participants with a diagnosis of primary SjD for at least 12 months prior to the Screening Visit and meet classification criteria for primary SjS according to the 2016 American College of Rheumatology/ European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome at the time of screening.
Participants with moderate to severe systemic disease activity as determined by a clinESSDAI total score ≥ 5 at the Screening Visit.
Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at the Screening Visit.
Participants have residual salivary flow as measured by stimulated whole salivary flow rate ≥ 0.01 milliliters per minute (mL/min) at the Screening Visit.
Participants with a diagnosis of secondary SjD, inadequately treated fibromyalgia, other confirmed connective tissue, rheumatic, or systemic inflammatory autoimmune disease including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, or polymyositis, that in the opinion of the Investigator, is likely to interfere with the ability to assess primary SjD manifestations.
Participants with a history of clinically significant monoclonal gammopathy, including but not limited to monoclonal gammopathy of undetermined significance, history of multiple myeloma or non-Hodgkin's lymphoma, or have an active malignancy or history of malignancy within 5 years prior to the Screening Visit.
Parallel
IMVT-1402
DrugAdministered once weekly by subcutaneous injection
Placebo
DrugAdministered once weekly by subcutaneous injection
Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
The clinESSDAI is a tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome.
Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 1 compared to Placebo
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Change from Baseline in clinESSDAI score at Week 24 for IMVT-1402 Dose 2 compared to Placebo
Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 2 compared to Placebo
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 1 compared to Placebo
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
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