Condition

Atopic Dermatitis

Compensation

$880.00

Duration

24 Weeks

Atopic Dermatitis

Official Title

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

Study Summary

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.

Eligibility and Recruitment Information

Recruitment Status Recruiting
Eligible Genders Both
Eligible Ages 18 - 75
Inclusion • 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 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 treatments are otherwise medically inadvisable. • Daily use of non-medicated emollient for at least 7 days prior to baseline.
Exclusion • 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.
Start Date October 9, 2018
Healthy Volunteers 1 Ineligible
Compensation $880.00
Location Orlando, FL

Study Information

Condition Atopic Dermatitis

Administrative Information

Study ID NCT03533751

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