This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects With Moderate to Severe Atopic Dermatitis (AD).

Study Overview
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Brief Summary
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This study will evaluate the safety, tolerability, and efficacy of ANB032 in subjects with moderate to severe atopic dermatitis (AD).

Detailed Description
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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).

Official Title
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A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of ANB032 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis

Conditions
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Atopic Dermatitis Eczema

Intervention / Treatment
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* Drug: ANB032
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male or female aged 18 to 65 years and in good general health Moderate to severe AD for at least 6 months prior to Randomization History of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable EASI score ≥ 16 at Screening and at Randomization vIGA AD score ≥ 3 at Screening and at Randomization AD involved BSA ≥ 10% at Screening and at Randomization Key Exclusion Criteria: Any factors that in the Investigator's opinion would predispose the subject to develop an infection Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status Not able to tolerate SC drug administration Tanning booth use or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks before Randomization

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ANB032 SC Dose 1<br>This arm will receive treatment SC | Drug: ANB032<br>* BTLA agonist antibody<br>|
| Experimental: ANB032 SC Dose 2<br>This arm will receive treatment SC | Drug: ANB032<br>* BTLA agonist antibody<br>|
| Experimental: ANB032 SC Dose 3<br>This arm will receive treatment SC | Drug: ANB032<br>* BTLA agonist antibody<br>|
| Placebo Comparator: Placebo<br>This arm will receive Placebo SC | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Proportion of subjects who achieve ≥ 75% reduction (improvement) from Baseline in EASI-75 at Week 14 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ANB032, B and T lymphocyte attenuator BTLA