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

AnaptysBio

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Biological: Etokimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03533751

ANB020-005

2018-000331-27 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 302 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female participants 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 kilogram per square meter (kg/m^2) at screening.
3. Clinically confirmed diagnosis of 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. 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.
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-interleukin (IL)-33 antibody.
3. 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.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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302 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks.

Treatment:

Drug: Placebo

Etokimab 20 mg SC Q4W

Experimental group

Description:

Participants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks.

Treatment:

Biological: Etokimab

Etokimab 300 mg load + 150 mg SC Q8W

Experimental group

Description:

Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.

Treatment:

Drug: Placebo

Biological: Etokimab

Etokimab 300 mg load + 150 mg SC Q4W

Experimental group

Description:

Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.

Treatment:

Biological: Etokimab

Etokimab 600 mg load + 300 mg SC Q4W

Experimental group

Description:

Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.

Treatment:

Biological: Etokimab