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ANB032 did not meet the primary endpoint in moderate-to-severe atopic dermatitis
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This study will evaluate the safety, tolerability, and efficacy of ANB032 in subjects with moderate to severe atopic dermatitis (AD).
This is a Phase 2, randomized, double blind, placebo controlled, parallel group, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of ANB032 in subjects with moderate to severe atopic dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANB032 SC Dose 1 | Experimental | This arm will receive treatment SC |
|
| ANB032 SC Dose 2 | Experimental | This arm will receive treatment SC |
|
| ANB032 SC Dose 3 | Experimental | This arm will receive treatment SC |
|
| Placebo | Placebo Comparator | This arm will receive Placebo SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANB032 | Drug | BTLA agonist antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieve ≥75% reduction (improvement) from Baseline in EASI-75 as Week 14 | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72. | Baseline to Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean percent change from Baseline in EASI at Week 14 | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72. | Baseline to Week 14 |
| Mean change from Baseline in EASI at Week 14 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Rigby, MD | AnaptysBio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AnaptysBio Investigative Site 10-140 | Anaheim | California | 92801 | United States | ||
| AnaptysBio Investigative Site 10-141 |
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| Placebo | Drug | Placebo |
|
| Baseline to Week 14 |
| Proportion of subjects who achieve a vIGA-AD score of 0 or 1 and ≥ 2-point reduction (improvement) from Baseline in vIGA-AD score at Week 14 | Baseline to Week 14 |
| Cerritos |
| California |
| 90703 |
| United States |
| AnaptysBio Investigative Site 10-121 | Fountain Valley | California | 92708 | United States |
| AnaptysBio Investigative Site 10-107 | Fremont | California | 94538 | United States |
| AnaptysBio Investigative Site 10-120 | Lancaster | California | 93534 | United States |
| AnaptysBio Investigative 10-125 | Lomita | California | 90717 | United States |
| AnaptysBio Investigative Site 10-146 | Oxnard | California | 93030 | United States |
| AnaptysBio Investigative Site 10-147 | Pasadena | California | 91101 | United States |
| AnaptysBio Investigative Site 10-112 | Santa Monica | California | 90404 | United States |
| AnaptysBio Investigative Site 10-136 | Doral | Florida | 33122 | United States |
| AnaptysBio Investigative Site 10-133 | Miami | Florida | 33125 | United States |
| AnaptysBio Investigative Site 10-116 | Miami | Florida | 33126 | United States |
| AnaptysBio Investigative Site 10-134 | Miami | Florida | 33174 | United States |
| AnaptysBio Investigative Site 10-106 | Miami | Florida | 33179 | United States |
| AnaptysBio Investigative Site 10-122 | Atlanta | Georgia | 30328 | United States |
| AnaptysBio Investigative Site 10-130 | Boise | Idaho | 83702 | United States |
| AnaptysBio Investigative Site 10-151 | Flossmoor | Illinois | 60422 | United States |
| AnaptysBio Investigative Site 10-127 | Clarksville | Indiana | 47129 | United States |
| AnaptysBio Investigative Site 10-149 | Merrillville | Indiana | 46410 | United States |
| AnaptysBio Investigative Site 10-128 | New Albany | Indiana | 47150 | United States |
| AnaptysBio Investigative Site 10-137 | Baton Rouge | Louisiana | 70808 | United States |
| AnaptysBio Investigative Site 10-131 | Methuen | Massachusetts | 01844 | United States |
| AnaptysBio Investigative Site 10-126 | Ann Arbor | Michigan | 48109 | United States |
| AnaptysBio Investigative Site 10-139 | Auburn Hills | Michigan | 48326 | United States |
| AnaptysBio Investigative Site 10-114 | Detroit | Michigan | 48202 | United States |
| AnaptysBio Investigative Site 10-138 | Troy | Michigan | 48084 | United States |
| AnaptysBio Investigative Site 10-150 | Hazelwood | Missouri | 63042 | United States |
| AnaptysBio Investigative Site 10-110 | Saint Joseph | Missouri | 64506 | United States |
| AnaptysBio Investigative Site 10-148 | Las Vegas | Nevada | 89121 | United States |
| AnaptysBio Investigative Site 10-109 | Charlotte | North Carolina | 28277 | United States |
| AnaptysBio Investigative Site 10-108 | Wilmington | North Carolina | 28205 | United States |
| AnaptysBio Investigative Site 10-129 | Mason | Ohio | 45040 | United States |
| AnaptysBio Investigative Site 10-113 | Portland | Oregon | 97223 | United States |
| AnaptysBio Investigative Site 10-145 | Philadelphia | Pennsylvania | 19144 | United States |
| AnaptysBio Investigative Site 10-119 | Nashville | Tennessee | 37215 | United States |
| AnaptysBio Investigative Site 10-144 | Baytown | Texas | 77521 | United States |
| AnaptysBio Investigative Site 10-124 | Dallas | Texas | 75235 | United States |
| AnaptysBio Investigative Site 10-105 | Frisco | Texas | 75034 | United States |
| AnaptysBio Investigative Site 10-142 | Katy | Texas | 77494 | United States |
| AnaptysBio Investigative Site 10-104 | San Antonio | Texas | 78213 | United States |
| AnaptysBio Investigative Site 10-132 | Spokane | Washington | 99202 | United States |
| AnaptysBio Investigative Site 35-103 | Woolloongabba | Queensland | 4102 | Australia |
| AnaptysBio Investigative Site 35-104 | Coorparoo | 4151 | Australia |
| AnaptysBio Investigative Site 11-105 | Surrey | British Colombia | V3V 0C6 | Canada |
| AnaptysBio Investigative Site 11-102 | Barrie | Ontario | L4M 7G1 | Canada |
| AnaptysBio Investigative Site 11-106 | Etobicoke | Ontario | M8X 1Y9 | Canada |
| AnaptysBio Investigative Site 11-101 | London | Ontario | N6H 5L5 | Canada |
| AnaptysBio Investigative Site 11-103 | North Bay | Ontario | P1B327 | Canada |
| AnaptysBio Investigative Site 11-107 | Richmond Hill | Ontario | L4B 1A5 | Canada |
| AnaptysBio Investigative Site 57-104 | Pardubice | 53002 | Czechia |
| AnaptysBio Investigative Site 57-105 | Prague | 11000 | Czechia |
| AnaptysBio Investigative Site 57-102 | Prague | 13000 | Czechia |
| AnaptysBio Investigative Site 57-101 | Prague | 1500 | Czechia |
| AnaptysBio Investigative Site 59-105 | Tbilisi | 0112 | Georgia |
| AnaptysBio Investigative Site 59-106 | Tbilisi | 0114 | Georgia |
| AnaptysBio Investigative Site 59-101 | Tbilisi | 0141 | Georgia |
| AnaptysBio Investigative Site 59-102 | Tbilisi | 0160 | Georgia |
| AnaptysBio Investigative Site 59-103 | Tbilisi | 0160 | Georgia |
| AnaptysBio Investigative Site 59-104 | Tbilisi | 0160 | Georgia |
| AnaptysBio Investigative Site 59-107 | Tbilisi | 0179 | Georgia |
| AnaptysBio Investigative Site 36-101 | Grafton | 1010 | New Zealand |
| AnaptysBio Investigative Site 36-104 | Nelson | 7011 | New Zealand |
| AnaptysBio Investigative Site 36-102 | Rosedale | 0632 | New Zealand |
| AnaptysBio Investigative Site 36-103 | Wellington | 6021 | New Zealand |
| AnaptysBio Investigative Site 30-111 | Bydgoszcz | 85-079 | Poland |
| AnaptysBio Investigative Site 30-113 | Częstochowa | 42-217 | Poland |
| AnaptysBio Investigative Site 30-108 | Gdansk | 80-214 | Poland |
| AnaptysBio Investigative Site 30-106 | Krakow | 31-559 | Poland |
| AnaptysBio Investigative Site 30-101 | Lodz | 90-436 | Poland |
| AnaptysBio Investigative Site 30-109 | Rzeszów | 35-055 | Poland |
| AnaptysBio Investigative Site 30-115 | Skierniewice | 96-100 | Poland |
| AnaptysBio Investigative Site 30-112 | Szczecin | 70-332 | Poland |
| AnaptysBio Investigative Site 30-102 | Świdnik | 21-040 | Poland |
| AnaptysBio Investigative Site 30-105 | Warsaw | 00-874 | Poland |
| AnaptysBio Investigative Site 30-107 | Warsaw | 01-817 | Poland |
| AnaptysBio Investigative Site 30-116 | Warsaw | 02-677 | Poland |
| AnaptysBio Investigative Site 30-104 | Wroclaw | 50-566 | Poland |
| AnaptysBio Investigative Site 30-114 | Wroclaw | 51-503 | Poland |