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



Status:Recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:3/14/2019
Start Date:May 23, 2018
End Date:September 2019
Contact:Kham Phenis
Email:ANB020-005@anaptysbio.com
Phone:858-362-6295

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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

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.

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.
We found this trial at
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Houston, Texas 77058
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Albany, Georgia 31707
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