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