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

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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.