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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520831-18-00 | EU Trial (CTIS) Number |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: IMVT-1402 Dose 1 | Experimental |
| |
| Group 2: IMVT-1402 Dose 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMVT-1402 | Drug | Administered once weekly by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 1 compared to Placebo | 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 |
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Inclusion Criteria:
Additional inclusion criteria are defined in the protocol.
Exclusion Criteria:
Additional exclusion criteria are defined in the protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Central Study Contact | Contact | 18007970414 | clinicaltrials@immunovant.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Number - 1027 | Recruiting | Covina | California | 91722 | United States | |
| Site Number - 1007 |
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The Sponsor will also be blinded in the study.
| Placebo | Drug | Administered once weekly by subcutaneous injection |
|
| Baseline, Week 24 |
| Proportion of clinESSDAI responders at Week 24 for IMVT-1402 Dose 2 compared to Placebo | 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 | 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 | 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 | 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 | 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 |
| Recruiting |
| El Cajon |
| California |
| 91910 |
| United States |
| Site Number - 1016 | Recruiting | Menifee | California | 92586 | United States |
| Site Number - 1029 | Recruiting | Thousand Oaks | California | 91360 | United States |
| Site Number - 1026 | Recruiting | Upland | California | 91786 | United States |
| Site Number - 1014 | Recruiting | Fort Collins | Colorado | 80528 | United States |
| Site Number - 1018 | Recruiting | Hollywood | Florida | 33024 | United States |
| Site Number - 1021 | Recruiting | Jupiter | Florida | 33458 | United States |
| Site Number - 1002 | Recruiting | Miami | Florida | 33143 | United States |
| Site Number - 1004 | Recruiting | Tamarac | Florida | 33321 | United States |
| Site Number - 1025 | Recruiting | Tampa | Florida | 33606 | United States |
| Site Number - 1012 | Recruiting | Chicago | Illinois | 60607 | United States |
| Site Number - 1033 | Recruiting | Orland Park | Illinois | 60467 | United States |
| Site Number - 1030 | Recruiting | Lake Charles | Louisiana | 77469 | United States |
| Site Number - 1028 | Recruiting | New Orleans | Louisiana | 70112 | United States |
| Site Number - 1032 | Recruiting | Canton | New York | 13675 | United States |
| Site Number - 1006 | Recruiting | Mineola | New York | 11501 | United States |
| Site Number - 1013 | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Site Number - 1015 | Recruiting | Jackson | Tennessee | 38305 | United States |
| Site Number - 1000 | Recruiting | Memphis | Tennessee | 38119 | United States |
| Site Number - 1001 | Recruiting | Allen | Texas | 75013 | United States |
| Site Number - 1020 | Recruiting | Amarillo | Texas | 79124 | United States |
| Site Number - 1022 | Recruiting | Arlington | Texas | 75231 | United States |
| Site Number - 1019 | Recruiting | Austin | Texas | 78745 | United States |
| Site Number - 1024 | Recruiting | Grapevine | Texas | 76034 | United States |
| Site Number - 1011 | Recruiting | Houston | Texas | 77030 | United States |
| Site Number - 1010 | Recruiting | Houston | Texas | 77407 | United States |
| Site Number - 1023 | Recruiting | Katy | Texas | 77494 | United States |
| Site Number - 1031 | Recruiting | San Antonio | Texas | 78215 | United States |
| Site number - 5005 | Recruiting | Azcuénaga | Buenos Aires | C1128AAF | Argentina |
| Site Number - 5007 | Recruiting | Capital Federal | Buenos Aires | C1055AAF | Argentina |
| Site Number - 5008 | Not yet recruiting | San Isidro | Buenos Aires | B1643CRO | Argentina |
| Site Number - 5004 | Recruiting | San Miguel de Tucumán | Tucumán Province | T4000 | Argentina |
| Site Number - 5000 | Recruiting | Buenos Aires | B1646GHP | Argentina |
| Site Number - 5002 | Not yet recruiting | Buenos Aires | B1878DVB | Argentina |
| Site Number - 5003 | Recruiting | Buenos Aires | C1111AAJ | Argentina |
| Site Number - 5001 | Recruiting | Buenos Aires | C1417EYH | Argentina |
| Site number - 5006 | Recruiting | Buenos Aires | C1427CCL | Argentina |
| Site Number - 5506 | Not yet recruiting | Vitória | Espírito Santo | 01409-900 | Brazil |
| Site Number - 5504 | Not yet recruiting | Salvador | Estado de Bahia | 40150-150 | Brazil |
| Site Number - 5500 | Not yet recruiting | Juiz de Fora | Minas Gerais | 36010-570 | Brazil |
| Site Number - 5501 | Not yet recruiting | Curitiba | Paraná | 80030-110 | Brazil |
| Site Number - 5503 | Not yet recruiting | Porto Alegre | Rio Gtande Do Sul | 90480-003 | Brazil |
| Site Number - 5505 | Not yet recruiting | Porto Alegre | Rio Gtande Do Sul | 90560-030 | Brazil |
| Site Number - 2001 | Recruiting | Sherbrooke | Quebec | J1L 0H8 | Canada |
| Site Number - 2000 | Recruiting | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Site Number - 5700 | Recruiting | Santiago | Santiago de Chile | 7500571 | Chile |
| Site Number - 5702 | Not yet recruiting | Santiago | Santiago de Chile | 7500571 | Chile |
| Site Number - 5703 | Recruiting | Santiago | Santiago de Chile | 7500587 | Chile |
| Site Number - 5701 | Not yet recruiting | Santiago | Santiago de Chile | 7510047 | Chile |
| Site Number - 5704 | Recruiting | Santiago | Santiago de Chile | 8331143 | Chile |
| Site Number - 5706 | Recruiting | Viña del Mar | Valparaiso | 2520000 | Chile |
| Site Number - 5705 | Not yet recruiting | Osorno | 8380456 | Chile |
| Site Number - 5707 | Recruiting | Valdivia | 5110683 | Chile |
| Site Number - 5800 | Not yet recruiting | Medellín | Antioquia | 050034 | Colombia |
| Site Number - 5804 | Not yet recruiting | Barranquilla | Atlántico | 080002 | Colombia |
| Site Number - 5803 | Not yet recruiting | Bogotá | Cundinamarca | 110221 | Colombia |
| Site Number - 5802 | Not yet recruiting | Chía | Cundinamarca | 250008 | Colombia |
| Site Number - 5801 | Not yet recruiting | Bucaramanga | Santander Department | 680006 | Colombia |
| Site Number - 6504 | Recruiting | Bad Doberan | 18209 | Germany |
| Site Number - 6506 | Not yet recruiting | Cologne | 50937 | Germany |
| Site Number - 6500 | Recruiting | Hamburg | 20095 | Germany |
| Site Number - 6501 | Recruiting | Hanover | 30625 | Germany |
| Site Number - 6503 | Recruiting | Heidelberg | 69120 | Germany |
| Site number - 6502 | Recruiting | Munich | 80336 | Germany |
| Site Number - 6505 | Recruiting | Munich | 81667 | Germany |
| Site Number - 3901 | Recruiting | Athens | 11521 | Greece |
| Site Number - 3900 | Recruiting | Athens | 11527 | Greece |
| Site Number - 7550 | Recruiting | Budapest | 1027 | Hungary |
| Site Number - 7552 | Recruiting | Hódmezővásárhely | 6800 | Hungary |
| Site Number - 7551 | Recruiting | Kalocsa | 6300 | Hungary |
| Site Number - 7553 | Recruiting | Székesfehérvár | 8000 | Hungary |
| Site Number - 6000 | Recruiting | Catania | 95121 | Italy |
| Site Number - 6001 | Recruiting | Milan | 20132 | Italy |
| Site Number - 6006 | Not yet recruiting | Naples | 80131 | Italy |
| Site Number - 6002 | Recruiting | Palermo | 90129 | Italy |
| Site Number - 6005 | Not yet recruiting | Perugia | 06132 | Italy |
| Site Number - 6003 | Recruiting | Rome | 00128 | Italy |
| Site Number - 6007 | Withdrawn | Salerno | 84131 | Italy |
| Site Number - 2602 | Not yet recruiting | Guadalajara | Jalisco | 44931 | Mexico |
| Site Number - 2604 | Not yet recruiting | Cuautitlán Izcalli | State of Mexico | 54750 | Mexico |
| Site Number - 2605 | Not yet recruiting | Toluca | State of Mexico | 50090 | Mexico |
| Site Number - 2607 | Not yet recruiting | Mérida | Yucatán | 97070 | Mexico |
| Site Number - 2601 | Not yet recruiting | Chihuahua City | 31020 | Mexico |
| Site Number - 2600 | Not yet recruiting | Mexico City | 06700 | Mexico |
| Site Number - 2606 | Not yet recruiting | Mexico City | 07369 | Mexico |
| Site Number - 2603 | Not yet recruiting | Mexico City | 07760 | Mexico |
| Site Number - 2400 | Withdrawn | Cayma | Arequipa | 04017 | Peru |
| Site Number - 2401 | Recruiting | Santiago de Surco | Lima region | 15023 | Peru |
| Site Number - 2403 | Recruiting | Lima | 15076 | Peru |
| Site Number - 2402 | Recruiting | Lima | 15811 | Peru |
| Site Number - 3008 | Recruiting | Bydgoszcz | 85-065 | Poland |
| Site Number - 3010 | Recruiting | Krakow | 30-363 | Poland |
| Site Number - 3014 | Recruiting | Lodz | 31-426 | Poland |
| Site Number - 3004 | Recruiting | Lodz | 91-363 | Poland |
| Site Number - 3015 | Recruiting | Lublin | 20-412 | Poland |
| Site Number - 3005 | Recruiting | Lublin | 20-607 | Poland |
| Site Number - 3007 | Recruiting | Poznan | 60-693 | Poland |
| Site Number - 3000 | Recruiting | Poznan | 61-397 | Poland |
| Site Number - 3011 | Recruiting | Siedlce | 08-110 | Poland |
| Site Number - 3006 | Recruiting | Warsaw | 00-874 | Poland |
| Site Number - 3001 | Recruiting | Warsaw | 02-637 | Poland |
| Site Number - 3003 | Recruiting | Warsaw | 02-665 | Poland |
| Site Number - 3009 | Recruiting | Warsaw | 02-677 | Poland |
| Site Number - 3012 | Recruiting | Wołomin | 05-200 | Poland |
| Site Number - 3002 | Recruiting | Wroclaw | 50-556 | Poland |
| Site Number - 3013 | Recruiting | Wroclaw | 52-416 | Poland |
| Site Number - 7502 | Recruiting | Brasov | 500283 | Romania |
| Site Number - 7500 | Recruiting | Bucharest | 011172 | Romania |
| Site Number - 7501 | Recruiting | Cluj-Napoca | 400000 | Romania |
| Site Number - 7103 | Recruiting | Bilbao | 48013 | Spain |
| Site Number - 7106 | Recruiting | Cadiz | 11139 | Spain |
| Site Number - 7101 | Recruiting | Córdoba | 14004 | Spain |
| Site Number - 7102 | Recruiting | Mérida | 06800 | Spain |
| Site Number - 7100 | Withdrawn | Santa Cruz de Tenerife | 38001 | Spain |
| Site Number - 7104 | Recruiting | Valencia | 46010 | Spain |
| Site Number - 7004 | Recruiting | Cambridge | CB2 0QQ | United Kingdom |
| Site Number - 7003 | Recruiting | Liverpool | L9 7AL | United Kingdom |
| Site Number - 7002 | Recruiting | London | NW3 2QG | United Kingdom |
| Site Number - 7000 | Recruiting | Swindon | SN3 6BB | United Kingdom |
| Site Number - 7001 | Recruiting | Truro | TR1 3LJ | United Kingdom |