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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Primary Sjögren's Syndrome

In brief

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 Sjogren's disease (SjD).

Key facts

Study ID

NCT06979531

Run by

Immunovant Sciences GmbH

People needed

180

Starts

2025-06-30

Expected to finish

2029-07-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Site Number - 1007 — El Cajon, California, United States (enrolling)
• Site Number - 1016 — Menifee, California, United States (enrolling)
• Site Number - 1029 — Thousand Oaks, California, United States (enrolling)
• Site Number - 1026 — Upland, California, United States (enrolling)
• Site Number - 1014 — Fort Collins, Colorado, United States (enrolling)
• Site Number - 1018 — Hollywood, Florida, United States (enrolling)
• Site Number - 1021 — Jupiter, Florida, United States (enrolling)
• Site Number - 1002 — Miami, Florida, United States (enrolling)
• Site Number - 1004 — Tamarac, Florida, United States (enrolling)
• Site Number - 1025 — Tampa, Florida, United States (enrolling)
• Site Number - 1012 — Chicago, Illinois, United States (enrolling)
• Site Number - 1033 — Orland Park, Illinois, United States (enrolling)
• Site Number - 1030 — Lake Charles, Louisiana, United States (enrolling)
• Site Number - 1028 — New Orleans, Louisiana, United States (enrolling)
• Site Number - 1032 — Canton, New York, United States (enrolling)
• Site Number - 1006 — Mineola, New York, United States (enrolling)
• Site Number - 1013 — Philadelphia, Pennsylvania, United States (enrolling)
• Site Number - 1015 — Jackson, Tennessee, United States (enrolling)
• Site Number - 1000 — Memphis, Tennessee, United States (enrolling)
• Site Number - 1001 — Allen, Texas, United States (enrolling)
• Site Number - 1020 — Amarillo, Texas, United States (enrolling)
• Site Number - 1022 — Arlington, Texas, United States (enrolling)
• Site Number - 1019 — Austin, Texas, United States (enrolling)
• Site Number - 1024 — Grapevine, Texas, United States (enrolling)
• Site Number - 1027 — Covina, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.