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IMVT-1402 for adults with moderate to severe primary Sjögren's disease

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity

Phase 2 Interventional Immunovant Sciences GmbH · NCT06979531

This trial will test whether IMVT-1402 helps adults with moderate to severe primary Sjögren's disease reduce systemic disease activity compared with placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years to 74 Years
SexAll
SponsorImmunovant Sciences GmbH Industry-sponsored
Locations121 sites (Covina, California and 120 other locations)
Trial IDNCT06979531 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2b study compares IMVT-1402 to placebo in adults with seropositive primary Sjögren's disease and moderate to severe systemic involvement. Eligible participants must have had the diagnosis for at least 12 months, a clinESSDAI score of ≥5, and a stimulated whole salivary flow rate ≥0.01 mL/min at screening. The primary outcome is change from baseline in clinESSDAI at Week 24, with safety and longer-term follow-up through a total participation period of up to 105 weeks. Study procedures, dosing, and follow-up visits are conducted at multiple clinical sites and participants are randomized and blinded to treatment assignment.

Who should consider this trial

Good fit: Adults with a confirmed diagnosis of primary Sjögren's disease for at least 12 months who are seropositive for SSA/Ro, have moderate to severe systemic activity (clinESSDAI ≥5), and have stimulated salivary flow ≥0.01 mL/min are the ideal candidates.

Not a fit: Patients with secondary Sjögren's, inadequately treated fibromyalgia, other active connective tissue or systemic inflammatory diseases, low systemic activity (clinESSDAI <5), or who are seronegative for SSA/Ro are less likely to receive benefit from this treatment.

Why it matters

Potential benefit: If successful, IMVT-1402 could reduce systemic disease activity and improve symptoms and quality of life for people with moderate to severe primary Sjögren's disease.

How similar studies have performed: Previous biologic therapies targeting B cells and other immune pathways in Sjögren's have shown mixed results, so IMVT-1402 represents a related but still experimental approach with mid-stage data pending.

Eligibility criteria

Show full inclusion / exclusion 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, 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.

Additional exclusion criteria are defined in the protocol.

Where this trial is running

Covina, California and 120 other locations

+71 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Primary Sjögren's SyndromeSjogren DiseaseIMVT-1402Imeroprubart
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.