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

NCT06979531 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IMVT-1402-28012025-520831-18-00
• Study Type: interventional
• Target: 180
• Locations: 16 countries
• Sites: 121

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

Keywords

Sjogren Disease; IMVT-1402; Imeroprubart

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in clinESSDAI Score at Week 24 for IMVT-1402 Dose 1 compared to Placebo

  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 Outcomes (7)

• Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 1 compared to Placebo

  Week 24

• Change from Baseline in clinESSDAI score at Week 24 for IMVT-1402 Dose 2 compared to Placebo

  Baseline, Week 24

• Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 2 compared to Placebo

  Week 24

• Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 1 compared to Placebo

  Week 48

• Proportion of clinESSDAI responders at Week 48 for IMVT-1402 Dose 2 compared to Placebo

  Week 48

Study Arms (3)

Group 1: IMVT-1402 Dose 1

EXPERIMENTAL

Drug: IMVT-1402

Group 2: IMVT-1402 Dose 2

EXPERIMENTAL

Drug: IMVT-1402

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

IMVT-1402 DRUG

Administered once weekly by subcutaneous injection

Group 1: IMVT-1402 Dose 1; Group 2: IMVT-1402 Dose 2

Placebo DRUG

Administered once weekly by subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• Immunovant Sciences GmbH: lead

Study Sites (121)

Site Number - 1027

Covina, California, 91722, United States

RECRUITING

Site Number - 1007

El Cajon, California, 91910, United States

RECRUITING

Site Number - 1016

Menifee, California, 92586, United States

RECRUITING

Site Number - 1029

Thousand Oaks, California, 91360, United States

RECRUITING

Site Number - 1026

Upland, California, 91786, United States

RECRUITING

Site Number - 1014

Fort Collins, Colorado, 80528, United States

RECRUITING

Site Number - 1018

Hollywood, Florida, 33024, United States

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Site Number - 1021

Jupiter, Florida, 33458, United States

RECRUITING

Site Number - 1002

Miami, Florida, 33143, United States

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Site Number - 1004

Tamarac, Florida, 33321, United States

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Site Number - 1025

Tampa, Florida, 33606, United States

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Site Number - 1012

Chicago, Illinois, 60607, United States

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Site Number - 1033

Orland Park, Illinois, 60467, United States

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Site Number - 1030

Lake Charles, Louisiana, 77469, United States

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Site Number - 1028

New Orleans, Louisiana, 70112, United States

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Site Number - 1032

Canton, New York, 13675, United States

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Site Number - 1006

Mineola, New York, 11501, United States

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Site Number - 1013

Philadelphia, Pennsylvania, 19104, United States

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Site Number - 1015

Jackson, Tennessee, 38305, United States

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Site Number - 1000

Memphis, Tennessee, 38119, United States

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Site Number - 1001

Allen, Texas, 75013, United States

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Site Number - 1020

Amarillo, Texas, 79124, United States

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Site Number - 1022

Arlington, Texas, 75231, United States

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Site Number - 1019

Austin, Texas, 78745, United States

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Site Number - 1024

Grapevine, Texas, 76034, United States

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Site Number - 1011

Houston, Texas, 77030, United States

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Site Number - 1010

Houston, Texas, 77407, United States

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Site Number - 1023

Katy, Texas, 77494, United States

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Site Number - 1031

San Antonio, Texas, 78215, United States

RECRUITING

Site number - 5005

Azcuénaga, Buenos Aires, C1128AAF, Argentina

NOT YET RECRUITING

Site Number - 5007

Capital Federal, Buenos Aires, C1055AAF, Argentina

RECRUITING

Site Number - 5008

San Isidro, Buenos Aires, B1643CRO, Argentina

NOT YET RECRUITING

Site Number - 5004

San Miguel de Tucumán, Tucumán Province, T4000, Argentina

RECRUITING

Site Number - 5000

Buenos Aires, B1646GHP, Argentina

NOT YET RECRUITING

Site Number - 5002

Buenos Aires, B1878DVB, Argentina

NOT YET RECRUITING

Site Number - 5003

Buenos Aires, C1111AAJ, Argentina

NOT YET RECRUITING

Site Number - 5001

Buenos Aires, C1417EYH, Argentina

RECRUITING

Site number - 5006

Buenos Aires, C1427CCL, Argentina

RECRUITING

Site Number - 5506

Vitória, Espírito Santo, 01409-900, Brazil

NOT YET RECRUITING

Site Number - 5504

Salvador, Estado de Bahia, 40150-150, Brazil

NOT YET RECRUITING

Site Number - 5500

Juiz de Fora, Minas Gerais, 36010-570, Brazil

NOT YET RECRUITING

Site Number - 5501

Curitiba, Paraná, 80030-110, Brazil

NOT YET RECRUITING

Site Number - 5503

Porto Alegre, Rio Gtande Do Sul, 90480-003, Brazil

NOT YET RECRUITING

Site Number - 5505

Porto Alegre, Rio Gtande Do Sul, 90560-030, Brazil

NOT YET RECRUITING

Site Number - 2001

Sherbrooke, Quebec, J1L 0H8, Canada

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Site Number - 2000

Trois-Rivières, Quebec, G8Z 1Y2, Canada

RECRUITING

Site Number - 5700

Santiago, Santiago de Chile, 7500571, Chile

NOT YET RECRUITING

Site Number - 5702

Santiago, Santiago de Chile, 7500571, Chile

NOT YET RECRUITING

Site Number - 5703

Santiago, Santiago de Chile, 7500587, Chile

NOT YET RECRUITING

Site Number - 5701

Santiago, Santiago de Chile, 7510047, Chile

NOT YET RECRUITING

Site Number - 5704

Santiago, Santiago de Chile, 8331143, Chile

NOT YET RECRUITING

Site Number - 5706

Viña del Mar, Valparaiso, 2520000, Chile

NOT YET RECRUITING

Site Number - 5705

Osorno, 8380456, Chile

NOT YET RECRUITING

Site Number - 5707

Valdivia, 5110683, Chile

NOT YET RECRUITING

Site Number - 5800

Medellín, Antioquia, 050034, Colombia

NOT YET RECRUITING

Site Number - 5804

Barranquilla, Atlántico, 080002, Colombia

NOT YET RECRUITING

Site Number - 5803

Bogotá, Cundinamarca, 110221, Colombia

NOT YET RECRUITING

Site Number - 5802

Chía, Cundinamarca, 250008, Colombia

NOT YET RECRUITING

Site Number - 5801

Bucaramanga, Santander Department, 680006, Colombia

NOT YET RECRUITING

Site Number - 6504

Bad Doberan, 18209, Germany

RECRUITING

Site Number - 6506

Cologne, 50937, Germany

NOT YET RECRUITING

Site Number - 6500

Hamburg, 20095, Germany

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Site Number - 6501

Hanover, 30625, Germany

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Site Number - 6503

Heidelberg, 69120, Germany

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Site number - 6502

Munich, 80336, Germany

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Site Number - 6505

Munich, 81667, Germany

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Site Number - 3901

Athens, 11521, Greece

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Site Number - 3900

Athens, 11527, Greece

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Site Number - 7550

Budapest, 1027, Hungary

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Site Number - 7552

Hódmezővásárhely, 6800, Hungary

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Site Number - 7551

Kalocsa, 6300, Hungary

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Site Number - 7553

Székesfehérvár, 8000, Hungary

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Site Number - 6000

Catania, 95121, Italy

NOT YET RECRUITING

Site Number - 6001

Milan, 20132, Italy

NOT YET RECRUITING

Site Number - 6006

Naples, 80131, Italy

NOT YET RECRUITING

Site Number - 6002

Palermo, 90129, Italy

NOT YET RECRUITING

Site Number - 6005

Perugia, 06132, Italy

NOT YET RECRUITING

Site Number - 6003

Rome, 00128, Italy

RECRUITING

Site Number - 6007

Salerno, 84131, Italy

WITHDRAWN

Site Number - 2602

Guadalajara, Jalisco, 44931, Mexico

NOT YET RECRUITING

Site Number - 2604

Cuautitlán Izcalli, State of Mexico, 54750, Mexico

NOT YET RECRUITING

Site Number - 2605

Toluca, State of Mexico, 50090, Mexico

NOT YET RECRUITING

Site Number - 2607

Mérida, Yucatán, 97070, Mexico

NOT YET RECRUITING

Site Number - 2601

Chihuahua City, 31020, Mexico

NOT YET RECRUITING

Site Number - 2600

Mexico City, 06700, Mexico

NOT YET RECRUITING

Site Number - 2606

Mexico City, 07369, Mexico

NOT YET RECRUITING

Site Number - 2603

Mexico City, 07760, Mexico

NOT YET RECRUITING

Site Number - 2400

Cayma, Arequipa, 04017, Peru

NOT YET RECRUITING

Site Number - 2401

Santiago de Surco, Lima region, 15023, Peru

NOT YET RECRUITING

Site Number - 2403

Lima, 15076, Peru

NOT YET RECRUITING

Site Number - 2402

Lima, 15811, Peru

NOT YET RECRUITING

Site Number - 3008

Bydgoszcz, 85-065, Poland

RECRUITING

Site Number - 3010

Krakow, 30-363, Poland

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Site Number - 3014

Lodz, 31-426, Poland

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Site Number - 3004

Lodz, 91-363, Poland

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Site Number - 3015

Lublin, 20-412, Poland

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Site Number - 3005

Lublin, 20-607, Poland

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Site Number - 3007

Poznan, 60-693, Poland

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Site Number - 3000

Poznan, 61-397, Poland

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Site Number - 3011

Siedlce, 08-110, Poland

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Site Number - 3006

Warsaw, 00-874, Poland

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Site Number - 3001

Warsaw, 02-637, Poland

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Site Number - 3003

Warsaw, 02-665, Poland

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Site Number - 3009

Warsaw, 02-677, Poland

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Site Number - 3012

Wołomin, 05-200, Poland

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Site Number - 3002

Wroclaw, 50-556, Poland

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Site Number - 3013

Wroclaw, 52-416, Poland

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Site Number - 7502

Brasov, 500283, Romania

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Site Number - 7500

Bucharest, 011172, Romania

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Site Number - 7501

Cluj-Napoca, 400000, Romania

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Site Number - 7103

Bilbao, 48013, Spain

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Site Number - 7106

Cadiz, 11139, Spain

RECRUITING

Site Number - 7101

Córdoba, 14004, Spain

RECRUITING

Site Number - 7102

Mérida, 06800, Spain

RECRUITING

Site Number - 7100

Santa Cruz de Tenerife, 38001, Spain

WITHDRAWN

Site Number - 7104

Valencia, 46010, Spain

RECRUITING

Site Number - 7004

Cambridge, CB2 0QQ, United Kingdom

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Site Number - 7003

Liverpool, L9 7AL, United Kingdom

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Site Number - 7002

London, NW3 2QG, United Kingdom

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Site Number - 7000

Swindon, SN3 6BB, United Kingdom

RECRUITING

Site Number - 7001

Truro, TR1 3LJ, United Kingdom

RECRUITING

Central Study Contacts

Central Study Contact

CONTACT

18007970414; clinicaltrials@immunovant.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Sponsor will also be blinded in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (16); ME (8); DE (7); US (29); GR (2); PE (4); HU (4); CL (8); RO (3); IT (7); ES (6); BR (6); CO (5); CA (2); GB (5); AR (9)