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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515973-82-00 | EU Trial (CTIS) Number |
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This Phase 2b, multicenter, double-blind, placebo-controlled, randomized withdrawal study is designed to assess the efficacy and safety of IMVT-1402 in adult participants with active, difficult-to-treat, anti-citrullinated protein autoantibody (ACPA) positive rheumatoid arthritis (RA).
The primary objective is to evaluate the effects of IMVT-1402 compared to placebo, as measured by the American College of Rheumatology 20% (ACR20) response at Week 28.
The total duration of study participation is expected to be up to 86 weeks for an individual participant with 16 weeks of open-label treatment, 12 weeks of blinded randomized treatment, and 48 weeks of optional long-term extension treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMVT-1402 Dose 1 | Experimental |
| |
| 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 |
|---|---|---|
| Proportion of participants who maintain ACR20 response at Week 28 | Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Disease Activity Index (CDAI) score from Week 16 to Week 28 | Week 16 to Week 28 | |
| Change in Simplified Disease Activity Index (SDAI) score from Week 16 to Week 28 | Week 16 to Week 28 |
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Inclusion Criteria:
Additional inclusion criteria are defined in the protocol.
Exclusion Criteria:
Other, more specific exclusion criteria are defined in the protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Number - 1018 | Mesa | Arizona | 85210 | United States | ||
| Site Number - 1019 |
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| Placebo | Drug | Administered once weekly by subcutaneous injection. |
|
| Sun City |
| Arizona |
| 85351 |
| United States |
| Site Number - 1022 | Covina | California | 91722 | United States |
| Site Number - 1028 | San Leandro | California | 94578 | United States |
| Site Number - 1024 | Temecula | California | 92592 | United States |
| Site Number - 1033 | Tujunga | California | 91042 | United States |
| Site Number - 1023 | Whittier | California | 90602 | United States |
| Site Number - 1020 | Denver | Colorado | 80230 | United States |
| Site Number - 1015 | Jupiter | Florida | 33458 | United States |
| Site Number - 1002 | Miami | Florida | 33143 | United States |
| Site Number - 1027 | Plantation | Florida | 33324 | United States |
| Site Number - 1005 | Winter Park | Florida | 32789 | United States |
| Site Number - 1012 | Zephyrhills | Florida | 33542 | United States |
| Site Number - 1001 | Gainesville | Georgia | 30501 | United States |
| Site Number - 1034 | Chicago | Illinois | 60607 | United States |
| Site Number - 1006 | Cumberland | Maryland | 21502 | United States |
| Site Number - 1007 | Hagerstown | Maryland | 21740 | United States |
| Site Number - 1031 | Rockville | Maryland | 20850 | United States |
| Site Number - 1008 | Worcester | Massachusetts | 01605 | United States |
| Site Number - 1021 | Saint Clair Shores | Michigan | 48081 | United States |
| Site Number - 1030 | Kansas City | Missouri | 64151 | United States |
| Site Number - 1010 | Summit | New Jersey | 07901 | United States |
| Site Number - 1004 | Charlotte | North Carolina | 28207 | United States |
| Site Number - 1035 | Statesville | North Carolina | 28625 | United States |
| Site Number - 1000 | Duncansville | Pennsylvania | 16635 | United States |
| Site Number - 1016 | Jackson | Tennessee | 38305 | United States |
| Site Number - 1026 | Memphis | Tennessee | 38119 | United States |
| Site Number - 1029 | Murfreesboro | Tennessee | 37128 | United States |
| Site Number - 1037 | Allen | Texas | 75013 | United States |
| Site Number - 1017 | Colleyville | Texas | 76034 | United States |
| Site Number - 1036 | Katy | Texas | 77494 | United States |
| Site Number - 1014 | Mesquite | Texas | 75150 | United States |
| Site Number - 1013 | Tomball | Texas | 77375 | United States |
| Site Number - 1025 | Tomball | Texas | 77377 | United States |
| Site Number - 5003 | Buenos Aires | 1417 | Argentina |
| Site Number - 5001 | Buenos Aires | 1425 | Argentina |
| Site Number -5004 | Buenos Aires | C1046 | Argentina |
| Site Number - 5002 | Buenos Aires | C1118AAF | Argentina |
| Site Number - 5005 | Buenos Aires | C1180AAX | Argentina |
| Site Number - 5000 | San Miguel de Tucumán | 4000 | Argentina |
| Site Number - 5603 | Plovdiv | 4000 | Bulgaria |
| Site Number - 5605 | Plovdiv | 4002 | Bulgaria |
| Site Number - 5602 | Plovdiv | 4004 | Bulgaria |
| Site Number - 5604 | Rousse | 7000 | Bulgaria |
| Site Number - 5606 | Sevlievo | 5400 | Bulgaria |
| Site Number - 5600 | Sofia | 1336 | Bulgaria |
| Site Number - 5601 | Sofia | 1680 | Bulgaria |
| Site Number - 3204 | Brno | 638 00 | Czechia |
| Site Number - 3202 | Ostrava | 702 00 | Czechia |
| Site Number - 3203 | Praha 2 Nove Mesto | 128 50 | Czechia |
| Site Number - 3201 | Uherské Hradiště | 686 01 | Czechia |
| Site Number - 3200 | Zlín | 760 01 | Czechia |
| Site Number - 8000 | Tbilisi | 0159 | Georgia |
| Site Number - 8001 | Tbilisi | 0160 | Georgia |
| Site Number - 8003 | Tbilisi | 0186 | Georgia |
| Site Number - 6500 | Hamburg | 20095 | Germany |
| Site Number - 6501 | Ratingen | 40878 | Germany |
| Site Number - 7554 | Budapest | 1027 | Hungary |
| Site Number - 7555 | Budapest | 1027 | Hungary |
| Site Number - 7550 | Hódmezővásárhely | 6800 | Hungary |
| Site Number - 7553 | Kecskemét | 6000 | Hungary |
| Site Number - 7551 | Székesfehérvár | 8000 | Hungary |
| Site Number - 7552 | Veszprém | 8200 | Hungary |
| Site Number - 3005 | Bialystok | 15-879 | Poland |
| Site Number - 3007 | Elblag | 82-300 | Poland |
| Site Number - 3009 | Lublin | 20-607 | Poland |
| Site Number - 3006 | Nadarzyn | 05-830 | Poland |
| Site Number - 3008 | Poznan | 60-848 | Poland |
| Site Number - 3000 | Poznan | 61-397 | Poland |
| Site Number - 3003 | Sochaczew | 96-500 | Poland |
| Site Number - 3004 | Warsaw | 02-665 | Poland |
| Site Number - 3002 | Wroclaw | 53-673 | Poland |
| Site Number - 7500 | Brasov | 500283 | Romania |
| Site Number - 7502 | Bucharest | 020475 | Romania |
| Site Number - 7501 | Râmnicu Vâlcea | 240636 | Romania |
| Site Number - 7104 | Barcelona | 08208 | Spain |
| Site Number - 7101 | Bilbao | 48013 | Spain |
| Site Number - 7102 | Málaga | 29009 | Spain |
| Site Number - 7100 | Seville | 41009 | Spain |
| Site Number - 7000 | Edinburgh | EH4 2XU | United Kingdom |
| Site Number - 7001 | London | SE5 9RJ | United Kingdom |
| Site Number -7002 | North Shields | NE29 8NH | United Kingdom |
| Site Number - 7003 | Wolverhampton | WV10 0QP | United Kingdom |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
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