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IMVT-1402 for Moderate to Severe Primary Sjögren's Disease

This study is testing a drug called IMVT-1402 for adults with moderate to severe primary Sjögren's disease (a chronic autoimmune disease causing dry eyes and mouth, and sometimes affecting other organs). You might be able to join if you are between 18 and 74 years old and have been diagnosed with primary Sjögren's disease for at least 12 months. Participants will receive either IMVT-1402 or a placebo (an inactive substance) as a weekly injection under the skin. The main goal is to see if IMVT-1402 improves your disease activity score (clinESSDAI) after 24 weeks compared to the placebo. The current status of this study is unclear, and it plans to enroll about 180 participants.

Study design
This is a Phase 2b study that is randomized, meaning participants are assigned to groups by chance, and double-blinded, meaning neither you nor your doctor will know if you are receiving IMVT-1402 or the placebo. It plans to enroll 180 participants.
What's involved
Your total participation in the study is expected to last up to 105 weeks. You will receive weekly subcutaneous injections of either IMVT-1402 or placebo.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at Week 24, but total study participation is up to 105 weeks.

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NCT06979531

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

Recruiting
PHASE2Ages 18–74InterventionalTreatment
Immunovant Sciences GmbH
~180 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:IMVT-1402Placebo

At a glance

Recruiting sites
96 of 121 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
Measured over Baseline and at Week 24

Conditions

Primary Sjögren's Syndrome

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Where it's being run

121 sites across 40 states
Poland16
Texas9
Germany7
Italy7
Spain6
California5
Florida5
Argentina5

Who to contact

Central Study Contact
[email protected]
18007970414
Email the study team

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Do you actually qualify for this trial?

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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.

Exclusion

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.

What this trial measures

  • Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to PlaceboBaseline and at Week 24

    The clinESSDAI is a tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome.