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

June 5, 2026 updated by: Immunovant Sciences GmbH

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1878DVB
        • Not yet recruiting
        • Site Number - 5002
      • Buenos Aires, Argentina, C1427CCL
        • Recruiting
        • Site number - 5006
      • Buenos Aires, Argentina, C1417EYH
        • Recruiting
        • Site Number - 5001
      • Buenos Aires, Argentina, B1646GHP
        • Recruiting
        • Site Number - 5000
      • Buenos Aires, Argentina, C1111AAJ
        • Recruiting
        • Site Number - 5003
    • Buenos Aires
      • Azcuénaga, Buenos Aires, Argentina, C1128AAF
        • Recruiting
        • Site number - 5005
      • Capital Federal, Buenos Aires, Argentina, C1055AAF
        • Recruiting
        • Site Number - 5007
      • San Isidro, Buenos Aires, Argentina, B1643CRO
        • Not yet recruiting
        • Site Number - 5008
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000
        • Recruiting
        • Site Number - 5004
  • Brazil
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 01409-900
        • Not yet recruiting
        • Site Number - 5506
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40150-150
        • Not yet recruiting
        • Site Number - 5504
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Not yet recruiting
        • Site Number - 5500
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • Not yet recruiting
        • Site Number - 5501
    • Rio Gtande Do Sul
      • Porto Alegre, Rio Gtande Do Sul, Brazil, 90480-003
        • Not yet recruiting
        • Site Number - 5503
      • Porto Alegre, Rio Gtande Do Sul, Brazil, 90560-030
        • Not yet recruiting
        • Site Number - 5505
  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • Recruiting
        • Site Number - 2001
      • Trois-Rivières, Quebec, Canada, G8Z 1Y2
        • Recruiting
        • Site Number - 2000
  • Chile
      • Osorno, Chile, 8380456
        • Not yet recruiting
        • Site Number - 5705
      • Valdivia, Chile, 5110683
        • Not yet recruiting
        • Site Number - 5707
    • Santiago de Chile
      • Santiago, Santiago de Chile, Chile, 7500571
        • Not yet recruiting
        • Site Number - 5700
      • Santiago, Santiago de Chile, Chile, 7500571
        • Not yet recruiting
        • Site Number - 5702
      • Santiago, Santiago de Chile, Chile, 7500587
        • Not yet recruiting
        • Site Number - 5703
      • Santiago, Santiago de Chile, Chile, 7510047
        • Not yet recruiting
        • Site Number - 5701
      • Santiago, Santiago de Chile, Chile, 8331143
        • Not yet recruiting
        • Site Number - 5704
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520000
        • Not yet recruiting
        • Site Number - 5706
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050034
        • Not yet recruiting
        • Site Number - 5800
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080002
        • Not yet recruiting
        • Site Number - 5804
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 110221
        • Not yet recruiting
        • Site Number - 5803
      • Chía, Cundinamarca, Colombia, 250008
        • Not yet recruiting
        • Site Number - 5802
    • Santander Department
      • Bucaramanga, Santander Department, Colombia, 680006
        • Not yet recruiting
        • Site Number - 5801
  • Germany
      • Bad Doberan, Germany, 18209
        • Recruiting
        • Site Number - 6504
      • Cologne, Germany, 50937
        • Not yet recruiting
        • Site Number - 6506
      • Hamburg, Germany, 20095
        • Recruiting
        • Site Number - 6500
      • Hanover, Germany, 30625
        • Recruiting
        • Site Number - 6501
      • Heidelberg, Germany, 69120
        • Recruiting
        • Site Number - 6503
      • Munich, Germany, 81667
        • Recruiting
        • Site Number - 6505
      • Munich, Germany, 80336
        • Recruiting
        • Site number - 6502
  • Greece
      • Athens, Greece, 11521
        • Recruiting
        • Site Number - 3901
      • Athens, Greece, 11527
        • Recruiting
        • Site Number - 3900
  • Hungary
      • Budapest, Hungary, 1027
        • Recruiting
        • Site Number - 7550
      • Hódmezővásárhely, Hungary, 6800
        • Recruiting
        • Site Number - 7552
      • Kalocsa, Hungary, 6300
        • Recruiting
        • Site Number - 7551
      • Székesfehérvár, Hungary, 8000
        • Recruiting
        • Site Number - 7553
  • Italy
      • Catania, Italy, 95121
        • Recruiting
        • Site Number - 6000
      • Milan, Italy, 20132
        • Not yet recruiting
        • Site Number - 6001
      • Naples, Italy, 80131
        • Not yet recruiting
        • Site Number - 6006
      • Palermo, Italy, 90129
        • Recruiting
        • Site Number - 6002
      • Perugia, Italy, 06132
        • Not yet recruiting
        • Site Number - 6005
      • Rome, Italy, 00128
        • Recruiting
        • Site Number - 6003
      • Salerno, Italy, 84131
        • Withdrawn
        • Site Number - 6007
  • Mexico
      • Chihuahua City, Mexico, 31020
        • Not yet recruiting
        • Site Number - 2601
      • Mexico City, Mexico, 06700
        • Not yet recruiting
        • Site Number - 2600
      • Mexico City, Mexico, 07369
        • Not yet recruiting
        • Site Number - 2606
      • Mexico City, Mexico, 07760
        • Not yet recruiting
        • Site Number - 2603
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44931
        • Not yet recruiting
        • Site Number - 2602
    • State of Mexico
      • Cuautitlán Izcalli, State of Mexico, Mexico, 54750
        • Not yet recruiting
        • Site Number - 2604
      • Toluca, State of Mexico, Mexico, 50090
        • Not yet recruiting
        • Site Number - 2605
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Not yet recruiting
        • Site Number - 2607
  • Peru
      • Lima, Peru, 15076
        • Not yet recruiting
        • Site Number - 2403
      • Lima, Peru, 15811
        • Not yet recruiting
        • Site Number - 2402
    • Arequipa
      • Cayma, Arequipa, Peru, 04017
        • Withdrawn
        • Site Number - 2400
    • Lima region
      • Santiago de Surco, Lima region, Peru, 15023
        • Recruiting
        • Site Number - 2401
  • Poland
      • Bydgoszcz, Poland, 85-065
        • Recruiting
        • Site Number - 3008
      • Krakow, Poland, 30-363
        • Recruiting
        • Site Number - 3010
      • Lodz, Poland, 31-426
        • Recruiting
        • Site Number - 3014
      • Lodz, Poland, 91-363
        • Recruiting
        • Site Number - 3004
      • Lublin, Poland, 20-607
        • Recruiting
        • Site Number - 3005
      • Lublin, Poland, 20-412
        • Recruiting
        • Site Number - 3015
      • Poznan, Poland, 61-397
        • Recruiting
        • Site Number - 3000
      • Poznan, Poland, 60-693
        • Recruiting
        • Site Number - 3007
      • Siedlce, Poland, 08-110
        • Recruiting
        • Site Number - 3011
      • Warsaw, Poland, 02-637
        • Recruiting
        • Site Number - 3001
      • Warsaw, Poland, 02-677
        • Recruiting
        • Site Number - 3009
      • Warsaw, Poland, 00-874
        • Recruiting
        • Site Number - 3006
      • Warsaw, Poland, 02-665
        • Recruiting
        • Site Number - 3003
      • Wołomin, Poland, 05-200
        • Recruiting
        • Site Number - 3012
      • Wroclaw, Poland, 52-416
        • Recruiting
        • Site Number - 3013
      • Wroclaw, Poland, 50-556
        • Recruiting
        • Site Number - 3002
  • Romania
      • Brasov, Romania, 500283
        • Recruiting
        • Site Number - 7502
      • Bucharest, Romania, 011172
        • Recruiting
        • Site Number - 7500
      • Cluj-Napoca, Romania, 400000
        • Recruiting
        • Site Number - 7501
  • Spain
      • Bilbao, Spain, 48013
        • Recruiting
        • Site Number - 7103
      • Cadiz, Spain, 11139
        • Recruiting
        • Site Number - 7106
      • Córdoba, Spain, 14004
        • Recruiting
        • Site Number - 7101
      • Mérida, Spain, 06800
        • Recruiting
        • Site Number - 7102
      • Santa Cruz de Tenerife, Spain, 38001
        • Withdrawn
        • Site Number - 7100
      • Valencia, Spain, 46010
        • Recruiting
        • Site Number - 7104
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Site Number - 7004
      • Liverpool, United Kingdom, L9 7AL
        • Recruiting
        • Site Number - 7003
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Site Number - 7002
      • Swindon, United Kingdom, SN3 6BB
        • Recruiting
        • Site Number - 7000
      • Truro, United Kingdom, TR1 3LJ
        • Recruiting
        • Site Number - 7001
  • United States
    • California
      • Covina, California, United States, 91722
        • Recruiting
        • Site Number - 1027
      • El Cajon, California, United States, 91910
        • Recruiting
        • Site Number - 1007
      • Menifee, California, United States, 92586
        • Recruiting
        • Site Number - 1016
      • Thousand Oaks, California, United States, 91360
        • Recruiting
        • Site Number - 1029
      • Upland, California, United States, 91786
        • Recruiting
        • Site Number - 1026
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • Site Number - 1014
    • Florida
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Site Number - 1018
      • Jupiter, Florida, United States, 33458
        • Recruiting
        • Site Number - 1021
      • Miami, Florida, United States, 33143
        • Recruiting
        • Site Number - 1002
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • Site Number - 1004
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Site Number - 1025
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Site Number - 1012
      • Orland Park, Illinois, United States, 60467
        • Recruiting
        • Site Number - 1033
    • Louisiana
      • Lake Charles, Louisiana, United States, 77469
        • Recruiting
        • Site Number - 1030
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Site Number - 1028
    • New York
      • Canton, New York, United States, 13675
        • Recruiting
        • Site Number - 1032
      • Mineola, New York, United States, 11501
        • Recruiting
        • Site Number - 1006
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Site Number - 1013
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Recruiting
        • Site Number - 1015
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Site Number - 1000
    • Texas
      • Allen, Texas, United States, 75013
        • Recruiting
        • Site Number - 1001
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Site Number - 1020
      • Arlington, Texas, United States, 75231
        • Recruiting
        • Site Number - 1022
      • Austin, Texas, United States, 78745
        • Recruiting
        • Site Number - 1019
      • Grapevine, Texas, United States, 76034
        • Recruiting
        • Site Number - 1024
      • Houston, Texas, United States, 77030
        • Recruiting
        • Site Number - 1011
      • Houston, Texas, United States, 77407
        • Recruiting
        • Site Number - 1010
      • Katy, Texas, United States, 77494
        • Recruiting
        • Site Number - 1023
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • Site Number - 1031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Administered once weekly by subcutaneous injection
Experimental: Group 1: IMVT-1402 Dose 1
Drug: IMVT-1402
Administered once weekly by subcutaneous injection
Experimental: Group 2: IMVT-1402 Dose 2
Drug: IMVT-1402
Administered once weekly by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
Time Frame: Baseline and at Week 24
The clinESSDAI is a tool used in clinical studies to measure the systemic disease activity in participants with primary Sjogren's syndrome.
Baseline and at Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 1 compared to Placebo
Time Frame: Week 24
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Week 24
Change from Baseline in clinESSDAI score at Week 24 for IMVT-1402 Dose 2 compared to Placebo
Time Frame: Baseline, Week 24
Baseline, Week 24
Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 2 compared to Placebo
Time Frame: Week 24
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Week 24
Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 1 compared to Placebo
Time Frame: Week 48
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Week 48
Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 2 compared to Placebo
Time Frame: Week 48
A clinESSDAI responder is defined as participants having achieved clinESSDAI ≥ 4 points improvement from Baseline.
Week 48
Change from baseline in Physician General Assessment of Disease Activity (PhGA) score at Week 24 for IMVT-1402 Dose 1 compared to Placebo
Time Frame: Baseline and at Week 24
The PhGA is a measure of the participant's current disease activity as assessed by the physician or another healthcare professional.
Baseline and at Week 24
Change from baseline in PhGA score at Week 24 for IMVT-1402 Dose 2 compared to Placebo
Time Frame: Baseline and at Week 24
The PhGA is a measure of the participant's current disease activity as assessed by the physician or another healthcare professional.
Baseline and at Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunovant Sciences GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

May 13, 2025

First Submitted That Met QC Criteria

May 13, 2025

First Posted (Actual)

May 20, 2025

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMVT-1402-2801
  • 2025-520831-18-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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