Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT03533751

Run by

AnaptysBio, Inc.

People needed

302

Starts

2018-06-19

Expected to finish

2019-12-03

Last updated by the study team

2023-05-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants must be 18 to 75 years of age, at the time of signing the informed consent.
• Body mass index (BMI) of 18 to ≤ 35 kilogram per square meter (kg/m\^2) at screening.
• 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.
• Participants 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.

You may not qualify if…

• Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole within 2 weeks before dosing.
• Prior exposure to an anti-interleukin (IL)-33 antibody.
• Exposure to an investigational or licensed or other anti T-helper 2 (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.

Where it is running

• Moore Clinical Research Inc. - Brandon — Tampa, Florida, United States
• Georgia Pollens Clinical Research Centers, Inc. — Albany, Georgia, United States
• Dermatologic Surgery Specialists — Macon, Georgia, United States
• Marietta Dermatology & The Skin Cancer Center - Marietta — Marietta, Georgia, United States
• Advanced Medical Research, PC — Sandy Springs, Georgia, United States
• Midwest Allergy, Sinus and Asthma, SC — Normal, Illinois, United States
• Kansas City Dermatology, PA — Overland Park, Kansas, United States
• DermResearch, PLLC — Louisville, Kentucky, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Great Lakes Research Group, Inc. — Bay City, Michigan, United States
• Grekin Skin Institute - Warren — Warren, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Skin Specialists, PC — Omaha, Nebraska, United States
• JDR Dermatology Research — Las Vegas, Nevada, United States
• The Dermatology Group — Verona, New Jersey, United States
• Albuquerque Clinical Trials, Inc. — Albuquerque, New Mexico, United States
• Forest Hills Dermatology Group — Forest Hills, New York, United States
• SRG — New York, New York, United States
• DermResearch Center of New York — Stony Brook, New York, United States
• Wilmington Dermatology Center — Wilmington, North Carolina, United States
• Ohio State University Clinical Trials Management Office — Columbus, Ohio, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Vital Prospects Clinical Research Institute, P.C. — Tulsa, Oklahoma, United States
• Clinical Research Institute of Southern Oregon, PC — Medford, Oregon, United States
• Compass Research Main — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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