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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Participants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks.
  • Drug: Placebo
    Administered by subcutaneous injection
Experimental
Etokimab 20 mg SC Q4W 		Participants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks.
  • Biological: Etokimab
    Humanized monoclonal antibody, administered by subcutaneous injection
    Other names:
    • ANB020
Experimental
Etokimab 300 mg load + 150 mg SC Q8W 		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.
  • Biological: Etokimab
    Humanized monoclonal antibody, administered by subcutaneous injection
    Other names:
    • ANB020
  • Drug: Placebo
    Administered by subcutaneous injection
Experimental
Etokimab 300 mg load + 150 mg SC Q4W 		Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.
  • Biological: Etokimab
    Humanized monoclonal antibody, administered by subcutaneous injection
    Other names:
    • ANB020
Experimental
Etokimab 600 mg load + 300 mg SC Q4W 		Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
  • Biological: Etokimab
    Humanized monoclonal antibody, administered by subcutaneous injection
    Other names:
    • ANB020

More Details

Status
Completed
Sponsor
AnaptysBio, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.