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| Name | Class |
|---|---|
| Innovaderm Research Inc. | OTHER |
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The purpose of this study is to determine the efficacy and safety of a monoclonal antibody, OpSCF, in the treatment of adults with moderate to severe Atopic Dermatitis (Eczema). OpSCF will be compared to a placebo.
OpSCF or placebo will be administered every 2 weeks for 14 weeks, and the efficacy will be assessed two weeks later. After that, subjects may choose to enter an Open Label Extension phase in which all subjects will receive OpSCF every 4 weeks for 40 additional weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OpSCF | Active Comparator | OpSCF, 600 mg, subcutaneously, every two weeks x 14 weeks |
|
| Placebo | Placebo Comparator | Matched placebo, subcutaneously, every two weeks x 14 weeks |
|
| Open Label Extension | Active Comparator | Subjects may choose to continue in an Open Label Extension (OLE) phase if they complete the randomized phase. All subjects regardless of treatment assignment in the randomized phase will receive OpSCF, 600 mg every 4 weeks for up to 36 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OpSCF | Biological | Monoclonal Antibody |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in Eczema Area and Severity Index (EASI) score from baseline at Week 16 | Validated measure of activity of atopic dermatitis. A score of 0 indicates clear or no eczema, 0.1 to 1.0 indicates almost clear, 1.1 to 7 indicates mild disease, 7.1 to 21 indicates moderate disease, 21.1 to 50 indicates severe disease, and greater than 51 indicates very severe disease. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs and SAEs | Safety | Through study completion, approximately 1 year including the open label extension phase |
| Proportion of subjects achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in vIGA-AD |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in blood biomarkers and IgE at Weeks 4, 8, 12, and 16 | Blood tests | 16 weeks |
| Change from baseline in skin biomarkers collected using skin biopsies at Weeks 4 and 16 (optional for consenting subjects) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Phillips | Opsidio, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Dermatology & Skin Health Center | Birmingham | Alabama | 33607 | United States | ||
| First OC Dermatology Research |
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Randomized, placebo controlled
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| Placebo |
| Biological |
Formulation buffer without active agent |
|
| OpSCF (Open Label Extension) | Biological | Subjects may continue on an Open Label Extension after completing the 16-week randomized portion of the study |
|
Validated Investigator scoring of AD activity
| 16 weeks |
| Change and percent change from baseline in weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) | Validated scale of subject-reported itch. The Peak Pruritus Numerical Rating Scale is a single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours based on the following question: 'On a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". | 16 weeks |
Histopathological examination
| 16 weeks |
| Change from baseline in skin biomarkers collected using tape strips at Weeks 4 and 16 (optional for consenting subjects) | Analysis of proteomics and mRNA levels | 16 weeks |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Axon Clinical Research | Inglewood | California | 90301 | United States |
| University Clinical Trials | San Diego | California | 92123 | United States |
| Unison Clinical Trials | Sherman Oaks | California | 91403 | United States |
| Skin Care Research | Boca Raton | Florida | 33456 | United States |
| Skin Research of South Florida | Miami | Florida | 33173 | United States |
| RM Medical Research | Miami Lakes | Florida | 33014 | United States |
| Advanced Clinical Research Institute | Tampa | Florida | 33607 | United States |
| Arlington Dermatology | Rolling Meadows | Illinois | 60008 | United States |
| Options Research Group | West Lafayette | Indiana | 47906 | United States |
| DS Research of Kentucky | Louisville | Kentucky | 40241 | United States |
| Oakland Hills Dermatology P.C | Auburn Hills | Michigan | 48326 | United States |
| Saginaw Bay Dermatology | Bay City | Michigan | 48706 | United States |
| Skin Cancer and Dermatology Institute | Reno | Nevada | 89509 | United States |
| Forest Hills Dermatology Group | Kew Gardens | New York | 11415 | United States |
| Rodgers Dermatology | Frisco | Texas | 75034 | United States |
| Dermatology Of Seattle | Bellevue | Washington | 98004 | United States |
| Oshawa Clinic Dermatology Trials | Oshawa | Ontario | L1H 1B9 | Canada |
| Research Toronto | Toronto | Ontario | M4W 2N2 | Canada |
| Innovaderm Research Inc | Montreal | Quebec | H2X 2V1 | Canada |
| Centre de Recherche Saint-Louis | Québec | Quebec | G1W 4R4 | Canada |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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