Phase 2a Study of Efficacy and Safety of OpSCF in Moderate to Severe Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of OpSCF in the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Biological: OpSCF
* Biological: Placebo
* Biological: OpSCF (Open Label Extension)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has clinically confirmed diagnosis of active AD Subject has at least a 6-month history of AD Subject is willing to use effective birth control Exclusion Criteria: Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study. Subject has any clinically significant medical condition that would put the subject at undue risk or interfere with interpretation of study results. Subject has used dupilumab within 26 weeks prior to Day 1 Subject has used tralokinumab within 12 weeks prior to Day 1

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, placebo controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OpSCF<br>OpSCF, 600 mg, subcutaneously, every two weeks x 14 weeks | Biological: OpSCF<br>* Monoclonal Antibody<br>|
| Placebo Comparator: Placebo<br>Matched placebo, subcutaneously, every two weeks x 14 weeks | Biological: Placebo<br>* Formulation buffer without active agent<br>|
| Active Comparator: Open Label Extension<br>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. | Biological: OpSCF<br>* Monoclonal Antibody<br>Biological: OpSCF (Open Label Extension)<br>* Subjects may continue on an Open Label Extension after completing the 16-week randomized portion of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eczema, Monoclonal Antibody