Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity
NCT ID: NCT06979531
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2025-06-30
2028-07-31
Brief Summary
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Detailed Description
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The total duration of study participation is expected to be up to 57 weeks for an individual participant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1: IMVT-1402 Dose 1
IMVT-1402
Administered once weekly by subcutaneous injection
Group 2: IMVT-1402 Dose 2
IMVT-1402
Administered once weekly by subcutaneous injection
Placebo
Placebo
Administered once weekly by subcutaneous injection
Interventions
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IMVT-1402
Administered once weekly by subcutaneous injection
Placebo
Administered once weekly by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
74 Years
ALL
No
Sponsors
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Immunovant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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Site Number - 1027
Covina, California, United States
Site Number - 1007
El Cajon, California, United States
Site Number - 1016
Menifee, California, United States
Site Number - 1029
Thousand Oaks, California, United States
Site Number - 1026
Upland, California, United States
Site Number - 1014
Fort Collins, Colorado, United States
Site Number - 1018
Hollywood, Florida, United States
Site Number - 1021
Jupiter, Florida, United States
Site Number - 1002
Miami, Florida, United States
Site Number - 1004
Tamarac, Florida, United States
Site Number - 1025
Tampa, Florida, United States
Site Number - 1012
Chicago, Illinois, United States
Site Number - 1033
Orland Park, Illinois, United States
Site Number - 1030
Lake Charles, Louisiana, United States
Site Number - 1028
New Orleans, Louisiana, United States
Site Number - 1032
Canton, New York, United States
Site Number - 1006
Mineola, New York, United States
Site Number - 1013
Philadelphia, Pennsylvania, United States
Site Number - 1015
Jackson, Tennessee, United States
Site Number - 1000
Memphis, Tennessee, United States
Site Number - 1001
Allen, Texas, United States
Site Number - 1020
Amarillo, Texas, United States
Site Number - 1022
Arlington, Texas, United States
Site Number - 1019
Austin, Texas, United States
Site Number - 1024
Grapevine, Texas, United States
Site Number - 1011
Houston, Texas, United States
Site Number - 1010
Houston, Texas, United States
Site Number - 1023
Katy, Texas, United States
Site Number - 1031
San Antonio, Texas, United States
Site number - 5005
Azcuénaga, Buenos Aires, Argentina
Site Number - 5007
Capital Federal, Buenos Aires, Argentina
Site Number - 5008
San Isidro, Buenos Aires, Argentina
Site Number - 5004
San Miguel de Tucumán, Tucumán Province, Argentina
Site Number - 5000
Buenos Aires, , Argentina
Site Number - 5002
Buenos Aires, , Argentina
Site Number - 5003
Buenos Aires, , Argentina
Site Number - 5001
Buenos Aires, , Argentina
Site number - 5006
Buenos Aires, , Argentina
Site Number - 5506
Vitória, Espírito Santo, Brazil
Site Number - 5504
Salvador, Estado de Bahia, Brazil
Site Number - 5500
Juiz de Fora, Minas Gerais, Brazil
Site Number - 5501
Curitiba, Paraná, Brazil
Site Number - 5503
Porto Alegre, Rio Gtande Do Sul, Brazil
Site Number - 5505
Porto Alegre, Rio Gtande Do Sul, Brazil
Site Number - 2001
Sherbrooke, Quebec, Canada
Site Number - 2000
Trois-Rivières, Quebec, Canada
Site Number - 5706
Viña del Mar, Región de Valparaíso, Chile
Site Number - 5700
Santiago, Santiago de Chile, Chile
Site Number - 5702
Santiago, Santiago de Chile, Chile
Site Number - 5703
Santiago, Santiago de Chile, Chile
Site Number - 5701
Santiago, Santiago de Chile, Chile
Site Number - 5704
Santiago, Santiago de Chile, Chile
Site Number - 5705
Osorno, , Chile
Site Number - 5707
Valdivia, , Chile
Site Number - 5800
Medellín, Antioquia, Colombia
Site Number - 5804
Barranquilla, Atlántico, Colombia
Site Number - 5803
Bogotá, Cundinamarca, Colombia
Site Number - 5802
Chía, Cundinamarca, Colombia
Site Number - 5801
Bucaramanga, Santander Department, Colombia
Site Number - 6504
Bad Doberan, , Germany
Site Number - 6506
Cologne, , Germany
Site Number - 6500
Hamburg, , Germany
Site Number - 6501
Hanover, , Germany
Site Number - 6503
Heidelberg, , Germany
Site number - 6502
Munich, , Germany
Site Number - 6505
Munich, , Germany
Site Number - 3901
Athens, , Greece
Site Number - 3900
Athens, , Greece
Site Number - 7550
Budapest, , Hungary
Site Number - 7552
Hódmezővásárhely, , Hungary
Site Number - 7551
Kalocsa, , Hungary
Site Number - 7553
Székesfehérvár, , Hungary
Site Number - 6000
Catania, , Italy
Site Number - 6001
Milan, , Italy
Site Number - 6006
Naples, , Italy
Site Number - 6002
Palermo, , Italy
Site Number - 6005
Perugia, , Italy
Site Number - 6003
Rome, , Italy
Site Number - 6007
Salerno, , Italy
Site Number - 2602
Guadalajara, Jalisco, Mexico
Site Number - 2604
Cuautitlán Izcalli, State of Mexico, Mexico
Site Number - 2605
Toluca, State of Mexico, Mexico
Site Number - 2607
Mérida, Yucatán, Mexico
Site Number - 2601
Chihuahua City, , Mexico
Site Number - 2600
Mexico City, , Mexico
Site Number - 2606
Mexico City, , Mexico
Site Number - 2603
Mexico City, , Mexico
Site Number - 2400
Cayma, Arequipa, Peru
Site Number - 2401
Santiago de Surco, Lima region, Peru
Site Number - 2403
Lima, , Peru
Site Number - 2402
Lima, , Peru
Site Number - 3008
Bydgoszcz, , Poland
Site Number - 3010
Krakow, , Poland
Site Number - 3014
Lodz, , Poland
Site Number - 3004
Lodz, , Poland
Site Number - 3015
Lublin, , Poland
Site Number - 3005
Lublin, , Poland
Site Number - 3007
Poznan, , Poland
Site Number - 3000
Poznan, , Poland
Site Number - 3011
Siedlce, , Poland
Site Number - 3006
Warsaw, , Poland
Site Number - 3001
Warsaw, , Poland
Site Number - 3003
Warsaw, , Poland
Site Number - 3009
Warsaw, , Poland
Site Number - 3012
Wołomin, , Poland
Site Number - 3002
Wroclaw, , Poland
Site Number - 3013
Wroclaw, , Poland
Site Number - 7502
Brasov, , Romania
Site Number - 7500
Bucharest, , Romania
Site Number - 7501
Cluj-Napoca, , Romania
Site Number - 7103
Bilbao, , Spain
Site Number - 7106
Cadiz, , Spain
Site Number - 7101
Córdoba, , Spain
Site Number - 7102
Mérida, , Spain
Site Number - 7100
Santa Cruz de Tenerife, , Spain
Site Number - 7104
Valencia, , Spain
Site Number - 7004
Cambridge, , United Kingdom
Site Number - 7003
Liverpool, , United Kingdom
Site Number - 7002
London, , United Kingdom
Site Number - 7000
Swindon, , United Kingdom
Site Number - 7001
Truro, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2025-520831-18-00
Identifier Type: CTIS
Identifier Source: secondary_id
IMVT-1402-2801
Identifier Type: -
Identifier Source: org_study_id
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