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The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.
A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety profile of various dose regimens of IMG-007 in adult participants with moderate-to-severe active atopic dermatitis (AD) up to 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMG-007 Dose 1 | Experimental | Subcutaneous injection as per protocol. |
|
| IMG-007 Dose 2 | Experimental | Subcutaneous injection as per protocol. |
|
| IMG-007 Dose 3 | Experimental | Subcutaneous injection as per protocol. |
|
| IMG-007 Dose 4 | Experimental | Subcutaneous injection as per protocol. |
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| IMG-007 Dose 5 | Experimental | Subcutaneous injection as per protocol. |
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| IMG-007 Dose 6 | Experimental | Subcutaneous injection as per protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMG-007 | Drug | Participants will receive IMG-007 subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean percent change from baseline in EASI at Week 24 | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving a vIGA-AD score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction from baseline at Week 24 | Baseline, Week 24 | |
| Proportion of participants achieving a ≥ 75% reduction in EASI (EASI-75) at Week 24 | Baseline, Week 24 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ADAPTIVE Study Lead | Contact | (858) 345-6927 | ADAPTIVE_StudyLead@imagenebio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inmagene Site 1 | Recruiting | Lancaster | California | 93534 | United States | |
| Inmagene Site 23 |
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| IMG-007 Dose 7 |
| Experimental |
Subcutaneous injection as per protocol. |
|
| Placebo Crossover Dose 1 | Placebo Comparator | Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol. |
|
| Placebo Crossover Dose 2 | Placebo Comparator | Subcutaneous placebo injection as per protocol. At crossover, IMG-007 subcutaneous injection as per protocol. |
|
| Placebo | Drug | Participants will receive a placebo subcutaneously. |
|
| Proportion of participants achieving a ≥ 90% reduction in EASI (EASI-90) at Week 24 | Baseline, Week 24 |
| Incidence and severity of TEAE including treatment-emergent SAEs | Baseline, End of Study |
| Recruiting |
| Los Angeles |
| California |
| 90095 |
| United States |
| Inmagene Site 19 | Recruiting | Ocala | Florida | 34470 | United States |
| Inmagene Site 4 | Recruiting | Tampa | Florida | 33609 | United States |
| Inmagene Site 2 | Recruiting | Rolling Meadows | Illinois | 60008 | United States |
| Inmagene Site 6 | Recruiting | Kew Gardens | New York | 11415 | United States |
| Inmagene Site 21 | Recruiting | New York | New York | 10029 | United States |
| Inmagene Site 11 | Recruiting | Woodbury | New York | 11797 | United States |
| Inmagene Site 20 | Recruiting | Charlotte | North Carolina | 28277 | United States |
| Inmagene Site 10 | Recruiting | Fargo | North Dakota | 58103 | United States |
| Inmagene Site 9 | Recruiting | Columbus | Ohio | 43213 | United States |
| Inmagene Site 5 | Recruiting | Mayfield Heights | Ohio | 44124 | United States |
| Inmagene Site 3 | Recruiting | Portland | Oregon | 97210 | United States |
| Inmagene Site 12 | Recruiting | Anderson | South Carolina | 29621 | United States |
| Inmagene Site 8 | Recruiting | Southlake | Texas | 76092 | United States |
| Inmagene Site 7 | Recruiting | Burien | Washington | 698168 | United States |
| Inmagene Site 15 | Recruiting | Surrey | British Columbia | V3R 6A7 | Canada |
| Inmagene Site 22 | Recruiting | Vancouver | British Columbia | V6H 4B1 | Canada |
| Inmagene Site 17 | Recruiting | Greater Sudbury | Ontario | P3C 1X8 | Canada |
| Inmagene Site 13 | Recruiting | Mississauga | Ontario | L4Y 4C5 | Canada |
| Inmagene Site 18 | Recruiting | North Bay | Ontario | P1B 3Z7 | Canada |
| Inmagene Site 14 | Recruiting | Montreal | Quebec | H2X 2V1 | Canada |
| Inmagene Site 16 | Recruiting | Saskatoon | Saskatchewan | S7K 2C1 | Canada |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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