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 |
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).
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.
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
33
sites
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