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

Last updated: May 6, 2026
Sponsor: Immunovant Sciences GmbH
Overall Status: Active - Recruiting

Phase

2

Condition

Dermatomyositis (Connective Tissue Disease)

Sjogren's Syndrome

Treatment

IMVT-1402

Placebo

Clinical Study ID

NCT06979531
IMVT-1402-2801
2025-520831-18-00
  • Ages 18-74
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Participants with a diagnosis of primary SjD for at least 12 months prior to theScreening Visit and meet classification criteria for primary SjS according to the 2016 American College of Rheumatology/ European League Against RheumatismClassification Criteria for Primary Sjogren's Syndrome at the time of screening.

  • Participants with moderate to severe systemic disease activity as determined by aclinESSDAI 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 salivaryflow rate ≥ 0.01 milliliters per minute (mL/min) at the Screening Visit.

Additional inclusion criteria are defined in the protocol.

Exclusion

Exclusion Criteria:

  • Participants with a diagnosis of secondary SjD, inadequately treated fibromyalgia,other confirmed connective tissue, rheumatic, or systemic inflammatory autoimmunedisease including but not limited to, rheumatoid arthritis, systemic lupuserythematosus, systemic sclerosis, dermatomyositis, or polymyositis, that in theopinion of the Investigator, is likely to interfere with the ability to assessprimary 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 malignancyor history of malignancy within 5 years prior to the Screening Visit.

Additional exclusion criteria are defined in the protocol.

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: IMVT-1402
Phase: 2
Study Start date:
June 30, 2025
Estimated Completion Date:
July 31, 2029

Study Description

The primary objective is to evaluate the efficacy, safety, and tolerability of IMVT-1402 compared to placebo, as measured by the change from baseline of Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) at Week 24.

The total duration of study participation is expected to be up to 105 weeks for an individual participant.

Connect with a study center

  • Site number - 5005

    Azcuénaga, Buenos Aires C1128AAF
    Argentina

    Active - Recruiting

  • Site Number - 5007

    Capital Federal, Buenos Aires C1055AAF
    Argentina

    Active - Recruiting

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    San Isidro, Buenos Aires B1643CRO
    Argentina

    Site Not Available

  • Site number - 5005

    Azcuénaga 3436203, Buenos Aires 3435907 C1128AAF
    Argentina

    Site Not Available

  • Site Number - 5008

    San Isidro 3428992, Buenos Aires 3435907 B1643CRO
    Argentina

    Site Not Available

  • Site Number - 5004

    San Miguel de Tucumán, Tucumán Province T4000
    Argentina

    Active - Recruiting

  • Site Number - 5004

    San Miguel de Tucumán 3836873, Tucumán Province 3833578 T4000
    Argentina

    Site Not Available

  • Site Number - 5000

    Buenos Aires, B1646GHP
    Argentina

    Active - Recruiting

  • Site Number - 5001

    Buenos Aires, C1417EYH
    Argentina

    Active - Recruiting

  • Site Number - 5002

    Buenos Aires, B1878DVB
    Argentina

    Site Not Available

  • Site Number - 5003

    Buenos Aires, C1111AAJ
    Argentina

    Active - Recruiting

  • Site number - 5006

    Buenos Aires, C1427CCL
    Argentina

    Active - Recruiting

  • Site Number - 5000

    Buenos Aires 3435910, B1646GHP
    Argentina

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    Buenos Aires 3435910, C1417EYH
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    Buenos Aires 3435910, B1878DVB
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    Buenos Aires 3435910, C1111AAJ
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    Buenos Aires 3435910, C1427CCL
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    Brazil

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    Vitória 3444924, Espírito Santo 3463930 01409-900
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    Salvador, Estado de Bahia 40150-150
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    Salvador 3450554, Estado de Bahia 3471168 40150-150
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    Curitiba 3464975, Paraná 3455077 80030-110
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    Porto Alegre, Rio Gtande Do Sul 90480-003
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    Porto Alegre, Rio Gtande Do Sul 90560-030
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    Porto Alegre 3452925, Rio Gtande Do Sul 90480-003
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    Porto Alegre 3452925, Rio Gtande Do Sul 90560-030
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    Canada

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    Santiago, Santiago de Chile 7500571
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    Santiago, Santiago de Chile 8331143
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    Santiago 3871336, Santiago de Chile 7500571
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    Bydgoszcz, 85-065
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    Bydgoszcz 3102014, 85-065
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    United States

    Site Not Available

  • Site Number - 1000

    Memphis 4641239, Tennessee 4662168 38119
    United States

    Site Not Available

  • Site Number - 1001

    Allen, Texas 75013
    United States

    Active - Recruiting

  • Site Number - 1020

    Amarillo, Texas 79124
    United States

    Active - Recruiting

  • Site Number - 1022

    Arlington, Texas 75231
    United States

    Active - Recruiting

  • Site Number - 1019

    Austin, Texas 78745
    United States

    Active - Recruiting

  • Site Number - 1024

    Grapevine, Texas 76034
    United States

    Active - Recruiting

  • Site Number - 1010

    Houston, Texas 77407
    United States

    Active - Recruiting

  • Site Number - 1011

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Site Number - 1023

    Katy, Texas 77494
    United States

    Active - Recruiting

  • Site Number - 1031

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • Site Number - 1001

    Allen 4670300, Texas 4736286 75013
    United States

    Site Not Available

  • Site Number - 1020

    Amarillo 5516233, Texas 4736286 79124
    United States

    Site Not Available

  • Site Number - 1022

    Arlington 4671240, Texas 4736286 75231
    United States

    Site Not Available

  • Site Number - 1019

    Austin 4671654, Texas 4736286 78745
    United States

    Site Not Available

  • Site Number - 1024

    Grapevine 4694568, Texas 4736286 76034
    United States

    Site Not Available

  • Site Number - 1010

    Houston 4699066, Texas 4736286 77407
    United States

    Active - Recruiting

  • Site Number - 1011

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Site Number - 1023

    Katy 4702732, Texas 4736286 77494
    United States

    Site Not Available

  • Site Number - 1031

    San Antonio 4726206, Texas 4736286 78215
    United States

    Site Not Available

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