Status:
RECRUITING
Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity
Lead Sponsor:
Immunovant Sciences GmbH
Conditions:
Primary Sjögren's Syndrome
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief Summary
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 Sjog...
Detailed Description
The primary objective is to evaluate the efficacy, safety, and tolerability of IMVT-1402 compared to placebo, as measured by the change from baseline of Clinical European League Against Rheumatism Sjo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06979531
Start Date
June 30 2025
End Date
July 1 2028
Last Update
December 8 2025
Active Locations (121)
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1
Site Number - 1027
Covina, California, United States, 91722
2
Site Number - 1007
El Cajon, California, United States, 91910
3
Site Number - 1016
Menifee, California, United States, 92586
4
Site Number - 1029
Thousand Oaks, California, United States, 91360