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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Site Number - 1027
  Covina, California, United States Recruiting
• Site Number - 1007
  El Cajon, California, United States Recruiting
• Site Number - 1016
  Menifee, California, United States Recruiting
• Site Number - 1029
  Thousand Oaks, California, United States Recruiting
• Site Number - 1026
  Upland, California, United States Recruiting
• Site Number - 1014
  Fort Collins, Colorado, United States Recruiting

+71 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Central Study Contact
• Email: clinicaltrials@immunovant.com
• Phone: 18007970414

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term assessment of patients with Primary Sjögren's Syndrome

  This study is trying to understand how Primary Sjögren's Syndrome changes over time and what complications it might cause for patients over 20 years.

  Recruiting Assistance Publique - Hôpitaux de Paris · Le Kremlin-Bicêtre, Val De Marne · NCT03040583

• Evaluating a Biomarker for Disease Activity in Primary Sjögren's Syndrome

  This study is testing if measuring a specific type of antibody in the blood can help doctors understand how active the disease is in people with Primary Sjögren's Syndrome.

  Recruiting at 5 sites Centre Hospitalier Universitaire de Saint Etienne · Bourgoin and 7 other locations · NCT03003572

• IMVT-1402 for adults with mild to severe generalized myasthenia gravis.

  This trial will test whether IMVT-1402 helps adults with mild to severe generalized myasthenia gravis improve symptoms and daily function compared with placebo.

  Recruiting at 88 sites Phase 3 Immunovant Sciences GmbH · Huntsville, Alabama and 87 other locations · NCT07039916

• Imeroprubart for adults with CIDP

  This study will test whether the monoclonal antibody Imeroprubart helps adults with active CIDP who are already on stable immunoglobulin or corticosteroid treatment.

  Recruiting at 117 sites Phase 2 Immunovant Sciences GmbH · Tucson, Arizona and 141 other locations · NCT07032662

• IMVT-1402 as a treatment for adults with Graves' disease

  This trial tests whether IMVT-1402 can lower thyroid overactivity in adults with Graves' disease who remain hyperthyroid despite antithyroid drugs.

  Recruiting at 157 sites Phase 2 Immunovant Sciences GmbH · Tucson, Arizona and 162 other locations · NCT07018323

• Assessing IMVT-1402 for treating Graves' disease in adults

  This study is testing a new treatment called IMVT-1402 to see if it can help adults with Graves' disease who still have high thyroid levels despite taking other medications.

  Recruiting at 124 sites Phase 2 Immunovant Sciences GmbH · Phoenix, Arizona and 133 other locations · NCT06727604

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.