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NCT06979531PHASE2Recruiting

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

Immunovant Sciences GmbH

Start Date

6/30/2025

Completion Date

7/1/2029

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).

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.

Eligibility Criteria

Age Range: 18 years to 74 years

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.

Interventions

DRUG

IMVT-1402

DRUG

Placebo

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Conditions

Primary Sjögren's Syndrome

Locations

Site Number - 1027

Covina, California 91722

United States

Site Number - 1007

El Cajon, California 91910

United States

Site Number - 1016

Menifee, California 92586

United States

Site Number - 1029

Thousand Oaks, California 91360

United States

Site Number - 1026

Upland, California 91786

United States

Site Number - 1014

Fort Collins, Colorado 80528

United States

Site Number - 1018

Hollywood, Florida 33024

United States

Site Number - 1021

Jupiter, Florida 33458

United States

Site Number - 1002

Miami, Florida 33143

United States

Site Number - 1004

Tamarac, Florida 33321

United States

Site Number - 1025

Tampa, Florida 33606

United States

Site Number - 1012

Chicago, Illinois 60607

United States

Site Number - 1033

Orland Park, Illinois 60467

United States

Site Number - 1030

Lake Charles, Louisiana 77469

United States

Site Number - 1028

New Orleans, Louisiana 70112

United States

Site Number - 1032

Canton, New York 13675

United States

Site Number - 1006

Mineola, New York 11501

United States

Site Number - 1013

Philadelphia, Pennsylvania 19104

United States

Site Number - 1015

Jackson, Tennessee 38305

United States

Site Number - 1000

Memphis, Tennessee 38119

United States

Site Number - 1001

Allen, Texas 75013

United States

Site Number - 1020

Amarillo, Texas 79124

United States

Site Number - 1022

Arlington, Texas 75231

United States

Site Number - 1019

Austin, Texas 78745

United States

Site Number - 1024

Grapevine, Texas 76034

United States

Site Number - 1011

Houston, Texas 77030

United States

Site Number - 1010

Houston, Texas 77407

United States

Site Number - 1023

Katy, Texas 77494

United States

Site Number - 1031

San Antonio, Texas 78215

United States

Site number - 5005

Azcuénaga, Buenos Aires C1128AAF

Argentina

Site Number - 5007

Capital Federal, Buenos Aires C1055AAF

Argentina

Site Number - 5008

San Isidro, Buenos Aires B1643CRO

Argentina

Site Number - 5004

San Miguel de Tucumán, Tucumán Province T4000

Argentina

Site Number - 5000

Buenos Aires, B1646GHP

Argentina

Site Number - 5002

Buenos Aires, B1878DVB

Argentina

Site Number - 5003

Buenos Aires, C1111AAJ

Argentina

Site Number - 5001

Buenos Aires, C1417EYH

Argentina

Site number - 5006

Buenos Aires, C1427CCL

Argentina

Site Number - 5506

Vitória, Espírito Santo 01409-900

Brazil

Site Number - 5504

Salvador, Estado de Bahia 40150-150

Brazil

Site Number - 5500

Juiz de Fora, Minas Gerais 36010-570

Brazil

Site Number - 5501

Curitiba, Paraná 80030-110

Brazil

Site Number - 5503

Porto Alegre, Rio Gtande Do Sul 90480-003

Brazil

Site Number - 5505

Porto Alegre, Rio Gtande Do Sul 90560-030

Brazil

Site Number - 2001

Sherbrooke, Quebec J1L 0H8

Canada

Site Number - 2000

Trois-Rivières, Quebec G8Z 1Y2

Canada

Site Number - 5700

Santiago, Santiago de Chile 7500571

Chile

Site Number - 5702

Santiago, Santiago de Chile 7500571

Chile

Site Number - 5703

Santiago, Santiago de Chile 7500587

Chile

Site Number - 5701

Santiago, Santiago de Chile 7510047

Chile

Site Number - 5704

Santiago, Santiago de Chile 8331143

Chile

Site Number - 5706

Viña del Mar, Valparaiso 2520000

Chile

Site Number - 5705

Osorno, 8380456

Chile

Site Number - 5707

Valdivia, 5110683

Chile

Site Number - 5800

Medellín, Antioquia 050034

Colombia

Site Number - 5804

Barranquilla, Atlántico 080002

Colombia

Site Number - 5803

Bogotá, Cundinamarca 110221

Colombia

Site Number - 5802

Chía, Cundinamarca 250008

Colombia

Site Number - 5801

Bucaramanga, Santander Department 680006

Colombia

Site Number - 6504

Bad Doberan, 18209

Germany

Site Number - 6506

Cologne, 50937

Germany

Site Number - 6500

Hamburg, 20095

Germany

Site Number - 6501

Hanover, 30625

Germany

Site Number - 6503

Heidelberg, 69120

Germany

Site number - 6502

Munich, 80336

Germany

Site Number - 6505

Munich, 81667

Germany

Site Number - 3901

Athens, 11521

Greece

Site Number - 3900

Athens, 11527

Greece

Site Number - 7550

Budapest, 1027

Hungary

Site Number - 7552

Hódmezővásárhely, 6800

Hungary

Site Number - 7551

Kalocsa, 6300

Hungary

Site Number - 7553

Székesfehérvár, 8000

Hungary

Site Number - 6000

Catania, 95121

Italy

Site Number - 6001

Milan, 20132

Italy

Site Number - 6006

Naples, 80131

Italy

Site Number - 6002

Palermo, 90129

Italy

Site Number - 6005

Perugia, 06132

Italy

Site Number - 6003

Rome, 00128

Italy

Site Number - 6007

Salerno, 84131

Italy

Site Number - 2602

Guadalajara, Jalisco 44931

Mexico

Site Number - 2604

Cuautitlán Izcalli, State of Mexico 54750

Mexico

Site Number - 2605

Toluca, State of Mexico 50090

Mexico

Site Number - 2607

Mérida, Yucatán 97070

Mexico

Site Number - 2601

Chihuahua City, 31020

Mexico

Site Number - 2600

Mexico City, 06700

Mexico

Site Number - 2606

Mexico City, 07369

Mexico

Site Number - 2603

Mexico City, 07760

Mexico

Site Number - 2400

Cayma, Arequipa 04017

Peru

Site Number - 2401

Santiago de Surco, Lima region 15023

Peru

Site Number - 2403

Lima, 15076

Peru

Site Number - 2402

Lima, 15811

Peru

Site Number - 3008

Bydgoszcz, 85-065

Poland

Site Number - 3010

Krakow, 30-363

Poland

Site Number - 3014

Lodz, 31-426

Poland

Site Number - 3004

Lodz, 91-363

Poland

Site Number - 3015

Lublin, 20-412

Poland

Site Number - 3005

Lublin, 20-607

Poland

Site Number - 3007

Poznan, 60-693

Poland

Site Number - 3000

Poznan, 61-397

Poland

Site Number - 3011

Siedlce, 08-110

Poland

Site Number - 3006

Warsaw, 00-874

Poland

Site Number - 3001

Warsaw, 02-637

Poland

Site Number - 3003

Warsaw, 02-665

Poland

Site Number - 3009

Warsaw, 02-677

Poland

Site Number - 3012

Wołomin, 05-200

Poland

Site Number - 3002

Wroclaw, 50-556

Poland

Site Number - 3013

Wroclaw, 52-416

Poland

Site Number - 7502

Brasov, 500283

Romania

Site Number - 7500

Bucharest, 011172

Romania

Site Number - 7501

Cluj-Napoca, 400000

Romania

Site Number - 7103

Bilbao, 48013

Spain

Site Number - 7106

Cadiz, 11139

Spain

Site Number - 7101

Córdoba, 14004

Spain

Site Number - 7102

Mérida, 06800

Spain

Site Number - 7100

Santa Cruz de Tenerife, 38001

Spain

Site Number - 7104

Valencia, 46010

Spain

Site Number - 7004

Cambridge, CB2 0QQ

United Kingdom

Site Number - 7003

Liverpool, L9 7AL

United Kingdom

Site Number - 7002

London, NW3 2QG

United Kingdom

Site Number - 7000

Swindon, SN3 6BB

United Kingdom

Site Number - 7001

Truro, TR1 3LJ

United Kingdom