Atopic Dermatitis Eczema
Conditions
Keywords
ANB032, B and T lymphocyte attenuator BTLA
Brief summary
This study will evaluate the safety, tolerability, and efficacy of ANB032 in subjects with moderate to severe atopic dermatitis (AD).
Detailed description
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).
Interventions
DRUGANB032
BTLA agonist antibody
DRUGPlacebo
Placebo
Sponsors
AnaptysBio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who achieve ≥75% reduction (improvement) from Baseline in EASI-75 as Week 14 | Baseline to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean percent change from Baseline in EASI at Week 14 | Baseline to 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. |
| Mean change from Baseline in EASI 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 | — |
Countries
Australia, Canada, Czechia, Georgia, New Zealand, Poland, United States
Outcome results
None listed