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Clinical Trials in the UK / NCT06979531
Active, not recruiting Phase 2

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

NCT06979531 · tracked via the Priya Life Science UK tracker
Sponsor
Immunovant Sciences GmbH
Phase
Phase 2
Started
2025-06-30
Last updated
2026-09-10

Condition(s) studied

Primary Sjögren's Syndrome

Investigational drug(s) / intervention(s)

IMVT-1402Placebo

IMVT-1402: Administered once weekly by subcutaneous injection

Placebo: Administered once weekly by subcutaneous injection

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (96)

FacilityCityRegionStatus
Site Number - 1027 Covina California
Site Number - 1007 El Cajon California
Site Number - 1016 Menifee California
Site Number - 1029 Thousand Oaks California
Site Number - 1026 Upland California
Site Number - 1014 Fort Collins Colorado
Site Number - 1018 Hollywood Florida
Site Number - 1021 Jupiter Florida
Site Number - 1002 Miami Florida
Site Number - 1004 Tamarac Florida
Site Number - 1025 Tampa Florida
Site Number - 1012 Chicago Illinois
Site Number - 1033 Orland Park Illinois
Site Number - 1030 Lake Charles Louisiana
Site Number - 1028 New Orleans Louisiana
Site Number - 1032 Canton New York
Site Number - 1006 Mineola New York
Site Number - 1013 Philadelphia Pennsylvania
Site Number - 1015 Jackson Tennessee
Site Number - 1000 Memphis Tennessee
Site Number - 1001 Allen Texas
Site Number - 1020 Amarillo Texas
Site Number - 1022 Arlington Texas
Site Number - 1019 Austin Texas
Site Number - 1024 Grapevine Texas
Site Number - 1011 Houston Texas
Site Number - 1010 Houston Texas
Site Number - 1023 Katy Texas
Site Number - 1031 San Antonio Texas
Site number - 5005 Azcuénaga Buenos Aires
Site Number - 5007 Capital Federal Buenos Aires
Site Number - 5004 San Miguel de Tucumán Tucumán Province
Site Number - 5000 Buenos Aires Argentina
Site Number - 5002 Buenos Aires Argentina
Site Number - 5003 Buenos Aires Argentina
Site Number - 5001 Buenos Aires Argentina
Site number - 5006 Buenos Aires Argentina
Site Number - 2001 Sherbrooke Quebec
Site Number - 2000 Trois-Rivières Quebec
Site Number - 5700 Santiago Santiago de Chile

+ 56 more sites — see the full list on the official registry below.

More Immunovant Sciences GmbH trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06979531 on ClinicalTrials.gov ↗ ← All trials in the UK