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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516745-39-00 | EU Trial (CTIS) Number |
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The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus.
The study will consist of 3 periods:
Period 1: eligible participants will be randomized 1:1 to IMVT-1402 Dose 1 or placebo SC QW for 12 weeks.
Period 2: participants who completed Period 1 will receive IMVT-1402 Dose 1 SC QW for 14 weeks.
Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks.
The total study duration per participant is approximately 61 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: Placebo | Placebo Comparator | Matching placebo for 12 weeks in Period 1 |
|
| IMVT-1402 Subcutaneous (SC) Once weekly (QW) | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMVT-1402 | Drug | Dose 1 or Dose 2 SC QW |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12 | The CLASI-A score represents the overall severity of cutaneous lupus erythematosus (CLE) dermatologic involvement. It is used to assess the activity of mucocutaneous lesions in patients with lupus. The score ranges from 0 (no active lesions) to a maximum of 70. Values between 1 and 9 indicate mild inflammation, 10 to 20 indicate moderate inflammation, and 21 or higher indicate severe inflammation. | Baseline (Day 1) and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who have a reduction in CLASI-A score of ≥ 5 points from Period 1 Baseline at Week 12 | Baseline (Day 1) and Week 12 | |
| Proportion of participants who have a reduction in CLASI-A score of ≥ 50% from Period 1 Baseline at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Number - 1010 | Anniston | Alabama | 36207-4780 | United States | ||
| Site Number - 1020 |
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| Placebo |
| Drug |
Matching Placebo SC QW |
|
| Baseline (Day 1) and Week 12 |
| Proportion of participants who have a reduction in CLASI-A score of ≥ 70% from Period 1 Baseline at Week 12 | Baseline (Day 1) and Week 12 |
| Birmingham |
| Alabama |
| 35203-4050 |
| United States |
| Site Number - 1038 | Phoenix | Arizona | 85037 | United States |
| Site Number - 1034 | Scottsdale | Arizona | 85260 | United States |
| Site Number - 1022 | Beverly Hills | California | 90211 | United States |
| Site Number - 1018 | Chula Vista | California | 91910 | United States |
| Site Number - 1039 | Corona | California | 92882 | United States |
| Site Number - 1005 | Fremont | California | 94538 | United States |
| Site Number - 1023 | Los Angeles | California | 90045 | United States |
| Site Number - 1000 | Aurora | Colorado | 80045-2541 | United States |
| Site Number - 1033 | Castle Rock | Colorado | 80109-8034 | United States |
| Site Number - 1021 | Farmington | Connecticut | 06030-2840 | United States |
| Site Number - 1014 | Hialeah | Florida | 33012 | United States |
| Site Number - 1017 | Jacksonville | Florida | 32256 | United States |
| Site Number - 1028 | Miami | Florida | 33122 | United States |
| Site Number - 1024 | Miami | Florida | 33133 | United States |
| Site Number - 1027 | Miami | Florida | 33136 | United States |
| Site Number - 1011 | Miami Lakes | Florida | 33014-5602 | United States |
| Site Number - 1025 | Orlando | Florida | 32819 | United States |
| Site Number - 1009 | Buford | Georgia | 30518-8721 | United States |
| Site Number - 1030 | Brighton | Massachusetts | 02135 | United States |
| Site Number - 1019 | Auburn Hills | Michigan | 48326-3396 | United States |
| Site Number - 1003 | Saint Clair Shores | Michigan | 48081-1274 | United States |
| Site Number - 1013 | Troy | Michigan | 48084 3536 | United States |
| Site Number - 1004 | Saint Joseph | Missouri | 64506-2459 | United States |
| Site Number - 1026 | St Louis | Missouri | 63104 | United States |
| Site Number - 1007 | Charlotte | North Carolina | 28211-1064 | United States |
| Site Number - 1008 | Durham | North Carolina | 27713-8505 | United States |
| Site Number - 1006 | Smithfield | North Carolina | 27577-4664 | United States |
| Site Number - 1002 | Hershey | Pennsylvania | 17033 | United States |
| Site Number - 1015 | Philadelphia | Pennsylvania | 19103-4708 | United States |
| Site Number - 1035 | Houston | Texas | 77030 | United States |
| Site Number - 1012 | Irving | Texas | 75061 | United States |
| Site Number -5004 | CABA | 1406 | Argentina |
| Site Number - 5000 | CABA | C1023AAB | Argentina |
| Site Number - 5001 | CABA | C1425DND | Argentina |
| Site Number - 5002 | San Miguel de Tucumán | T4000AXL | Argentina |
| Site Number - 5003 | San Miguel de Tucumán | T4000IHE | Argentina |
| Site Number - 5601 | Sofia | 1257 | Bulgaria |
| Site Number - 5603 | Sofia | 1431 | Bulgaria |
| Site Number - 5600 | Sofia | 1606 | Bulgaria |
| Site Number - 5605 | Sofia | 1618 | Bulgaria |
| Site Number - 5606 | Sofia | 1680 | Bulgaria |
| Site Number - 2000 | Calgary | Alberta | T2W 4X9 | Canada |
| Site Number - 2002 | Vancouver | British Columbia | V5Z 4E8 | Canada |
| Site Number - 2003 | Sarnia | Ontario | N7T 5W4 | Canada |
| Site Number - 5702 | Independencia | 8380000 | Chile |
| Site Number - 5704 | Santiago | 7640881 | Chile |
| Site Number - 5703 | Santiago | 8320000 | Chile |
| Site Number - 5701 | Temuco | 4810345 | Chile |
| Site Number - 5700 | Victoria | 4720638 | Chile |
| Site Number - 8002 | Tbilisi | 0112 | Georgia |
| Site Number - 8000 | Tbilisi | 0160 | Georgia |
| Site Number - 6502 | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Site Number - 6500 | Erlangen | Bavaria | 91054 | Germany |
| Site Number - 6501 | Oldenburg | Lower Saxony | 26133 | Germany |
| Site Number - 6503 | Bochum | North Rhine-Westphalia | 44791 | Germany |
| Site Number - 3902 | Attiki | Athens | 104 31 | Greece |
| Site Number - 3901 | Athens | Attica | 16121 | Greece |
| Site Number - 3903 | Thessaloniki | Central Macedonia | 56403 | Greece |
| Site Number - 3905 | Thessaloniki | Central Macedonia | 56403 | Greece |
| Site Number - 3906 | Heraklion | Crete | 71110 | Greece |
| Site Number - 3900 | Attiki | 12462 | Greece |
| Site Number - 3904 | Larissa | 411 10 | Greece |
| Site Number - 3004 | Poznan | Greater Poland Voivodeship | 60-702 | Poland |
| Site Number - 3005 | Gorzów Wielkopolski | Lubusz Voivodeship | 66-400 | Poland |
| Site Number - 3000 | Warsaw | Masovian Voivodeship | 00-716 | Poland |
| Site Number - 3001 | Warsaw | Masovian Voivodeship | 00-874 | Poland |
| Site Number - 3006 | Rzeszów | Pakistan | 35-055 | Poland |
| Site Number - 3002 | Rzeszów | Podkarpackie Voivodeship | 35-309 | Poland |
| Site Number - 3003 | Lodz | 90-436 | Poland |
| Site Number-1029 | Caguas | 00725-2443 | Puerto Rico |
| Site Number - 1037 | Ponce | 00716-0377 | Puerto Rico |
| Site Number - 1036 | San Juan | 918 | Puerto Rico |
| Site Number - 9000 | Belgrade | 11000 | Serbia |
| Site Number - 9001 | Belgrade | 11000 | Serbia |
| Site Number - 9003 | Novi Sad | 21000 | Serbia |
| Site Number - 7104 | Badalona | Catalonia | 8916 | Spain |
| Site Number - 7105 | Pamplona | Navarre | 31008 | Spain |
| Site Number - 7101 | Burjassot | Valencia | 46100 | Spain |
| Site Number - 7100 | Madrid | 28003 | Spain |
| Site Number - 7102 | Madrid | 28041 | Spain |
| Site Number - 7103 | Málaga | 29016 | Spain |
| Site Number - 7002 | Leeds | West Yorkshire | LS7 4SA | United Kingdom |
| Site Number - 7003 | London | SE1 9RT | United Kingdom |
| Site Number - 7000 | Manchester | M15 6SE | United Kingdom |
| ID | Term |
|---|---|
| D008178 | Lupus Erythematosus, Cutaneous |
| D008179 | Lupus Erythematosus, Discoid |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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