Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity

Launched by IMMUNOVANT SCIENCES GMBH · May 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IMVT-1402 for adults with primary Sjögren's syndrome, a condition that can cause dry eyes and mouth, among other symptoms. The researchers want to find out if IMVT-1402 is more effective than a placebo (a harmless sugar pill) in helping patients with moderate to severe symptoms over a 24-week period. They will also look at how many participants see a significant improvement in their symptoms after 48 weeks.

To participate, individuals must have been diagnosed with primary Sjögren's syndrome for at least a year and have moderate to severe systemic disease activity. They should also have certain antibodies related to the condition and some saliva production. However, those with other serious autoimmune diseases or specific health conditions will not be eligible to join. This study has not started recruiting yet, but if eligible, participants will receive either the treatment or the placebo and be monitored for their response and any side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • Additional inclusion criteria are defined in the protocol.
• Exclusion Criteria:
• • Participants with a diagnosis of secondary SjD or an autoimmune disease other than primary SjD that constitutes the principal illness, including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, pre-existing fibromyalgia or polymyositis, at the Screening Visit.
• • 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.
• • Additional exclusion criteria are defined in the protocol.