A Study Investigating the Efficacy, Safety, and PK Profile of ANB020 Administered to Adult Subjects With Moderate-to-Severe AD

Clinical Trial ID: NCT03533751

Description

This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of multiple doses of ANB020 in subjects with atopic dermatitis (AD).

This is a multi-center, 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.


Criteria

Inclusion Criteria: 1. Male or female subjects must be 18 to 75 years of age, at the time of signing the informed consent. 2. Body mass index (BMI) of 18 to ≤35 kg/m2 at screening. 3. Clinically confirmed diagnosis AD. 4. 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. 5. Subjects with a history of inadequate response to topical treatment, use of systemic treatments to treat AD, and/or for whom topical treatments are otherwise medically inadvisable. 6. Daily use of non-medicated emollient for at least 7 days prior to baseline. Exclusion Criteria: 1. Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole within 2 weeks before dosing. 2. Prior exposure to an anti-IL-33 antibody. 3. 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. 4. 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. 5. 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. 6. History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

  • Start Date

    2018-05-23

  • Last Updated

    2019-05-16

  • Sponsor

    AnaptysBio, Inc.

  • Condition Name

    Atopic Dermatitis

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