Recruiting
Phase 2

IMVT-1402

Sponsor:

Immunovant Sciences GmbH

Code:

NCT06979531

Conditions

Primary Sjögren's Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

IMVT-1402

Placebo

Study Details

Brief 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).

Conditions

Primary Sjögren's Syndrome

Study ID

NCT06979531

Start date

Jun 30, 2025

Status verified date

Aug, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: IMVT-1402 Dose 1

experimental: Group 2: IMVT-1402 Dose 2

placebo comparator: Placebo

Interventions

IMVT-1402

Administered once weekly by subcutaneous injection

Placebo

Administered once weekly by subcutaneous injection

Primary outcome measure

  • Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo [ Time Frame: Baseline and at Week 24 ]

Central Contacts and Locations

Central contacts

Central Study Contact

18007970414clinicaltrials@immunovant.com

Locations

Site Number - 1027

Recruiting

Covina, California, United States, 91722

Site Number - 1007

Recruiting

El Cajon, California, United States, 91910

Site Number - 1016

Recruiting

Menifee, California, United States, 92586

Site Number - 1029

Recruiting

Thousand Oaks, California, United States, 91360

Site Number - 1026

Recruiting

Upland, California, United States, 91786

Site Number - 1014

Recruiting

Fort Collins, Colorado, United States, 80528

Site Number - 1018

Recruiting

Hollywood, Florida, United States, 33024

Site Number - 1021

Recruiting

Jupiter, Florida, United States, 33458

Site Number - 1002

Recruiting

Miami, Florida, United States, 33143

Site Number - 1004

Recruiting

Tamarac, Florida, United States, 33321

Site Number - 1025

Recruiting

Tampa, Florida, United States, 33606

Site Number - 1012

Recruiting

Chicago, Illinois, United States, 60607

Site Number - 1033

Recruiting

Orland Park, Illinois, United States, 60467

Site Number - 1030

Recruiting

Lake Charles, Louisiana, United States, 77469

Site Number - 1028

Recruiting

New Orleans, Louisiana, United States, 70112

Site Number - 1032

Recruiting

Canton, New York, United States, 13675

Site Number - 1006

Recruiting

Mineola, New York, United States, 11501

Site Number - 1013

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Site Number - 1015

Recruiting

Jackson, Tennessee, United States, 38305

Site Number - 1000

Recruiting

Memphis, Tennessee, United States, 38119

Site Number - 1001

Recruiting

Allen, Texas, United States, 75013

Site Number - 1020

Recruiting

Amarillo, Texas, United States, 79124

Site Number - 1022

Recruiting

Arlington, Texas, United States, 75231

Site Number - 1019

Recruiting

Austin, Texas, United States, 78745

Site Number - 1024

Recruiting

Grapevine, Texas, United States, 76034

Site Number - 1011

Recruiting

Houston, Texas, United States, 77030

Site Number - 1010

Recruiting

Houston, Texas, United States, 77407

Site Number - 1023

Recruiting

Katy, Texas, United States, 77494

Site Number - 1031

Recruiting

San Antonio, Texas, United States, 78215

Site Number - 2001

Recruiting

Sherbrooke, Quebec, Canada, J1L 0H8

Site Number - 2000

Recruiting

Trois-Rivières, Quebec, Canada, G8Z 1Y2

More Information

Sponsor

Immunovant Sciences GmbH

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Sjogren Disease
  • IMVT-1402
  • Imeroprubart

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Immunovant Sciences GmbH on 2026-08-12.