Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Summary
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).
Timeline
- Start
- 2018-06-19
- Primary completion
- 2019-12-03
- Completion
- 2019-12-03
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs Etokimab 20 mg SC Q4W; p = 0.4498; Least Squares (LS) Mean Difference 7.75 (95% CI -12.4066 to 27.8983); ANCOVA NCT03533751 ↗
registry analysis (superiority test); Placebo vs Etokimab 300 mg / 150 mg SC Q8W; p = 0.5010; LS Mean Difference -6.32 (95% CI -24.7740 to 12.1262); ANCOVA NCT03533751 ↗
registry analysis (superiority test); Placebo vs Etokimab 300 mg / 150 mg SC Q4W; p = 0.8349; LS Mean Difference 1.97 (95% CI -16.6037 to 20.5476); ANCOVA NCT03533751 ↗
registry analysis (superiority test); Placebo vs Etokimab 600 mg / 300 mg SC Q4W; p = 0.6662; LS Mean Difference 4.82 (95% CI -17.1892 to 26.8275); ANCOVA NCT03533751 ↗
release “Topline Data From Etokimab ATLAS Phase 2b Clinical Trial in Moderate-to-Severe Atopic Dermatitis Failed to Meet Primary Endpoint” anaptysbio.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Etokimab | Monoclonal antibody | 20 mg | Subcutaneous |
| Subject | Etokimab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Etokimab | Monoclonal antibody | 300 mg | Subcutaneous |