EUCTR2018-000331-27-CZ
Active, not recruiting
Phase 1
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, and Pharmacokinetic Profile of ANB020 Administered to Adult Subjects with Moderate-to-Severe Atopic Dermatitis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Moderate-to-Severe Atopic Dermatitis
- Sponsor
- AnaptysBio, Inc.
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? Male or female subjects must be 18 to 75 years of age, at the time of
- •signing the informed consent.
- •? Body mass index (BMI) of 18 to \=35 kg/m2 for females and 18 to 40
- •kg/m2 for males, and total body weight \>50 kg (110 lb).
- •? Clinically confirmed diagnosis of AD.
- •? Eczema Area and Severity Index (EASI) score \=16, body surface area
- •(BSA) involvement \=10%, and an Investigator's Global Assessment
- •(IGA) score (5\-point scale) \=3 at baseline.
- •? Subjects with a history of inadequate response to topical treatment,
- •use of systemic treatments to treat AD, and/or for whom topical
Exclusion Criteria
- •? Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole within 2 weeks before dosing.
- •? Prior exposure to an anti\-IL\-33 antibody.
- •? Exposure to an investigational or licensed or other anti\-Th2\-type cytokine or cytokine receptor antagonist within 16 weeks or 5 half\-lives, whichever is longer.
- •? History of prior exposure to any investigational or biologic systemic treatment within 5 half\-lives of the screening or is currently enrolled in another clinical study.
- •? Have received systemic treatment for AD (including systemic corticosteroids, immunosuppressants or immunomodulating drugs, or phototherapy or use of a tanning booth) within 4 weeks before screening.
- •? History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Outcomes
Primary Outcomes
Not specified
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