Phase 2
Completed N=302
Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Source: ClinicalTrials.gov NCT03533751 ↗Enrolled (actual)
302
Serious AEs
4.0%
Results posted
May 2023
Primary outcomePrimary: Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score — -49.38; -41.63; -55.70; -47.40 percent change — p=0.4498
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score |
-49.38; -41.63; -55.70; -47.40; -44.56 | 0.4498 |
| SECONDARY Number of Participants With a 50% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 50 Response) at Week 16 |
21; 19; 27; 21; 18 | 0.7992 |
| SECONDARY Number of Participants With a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75 Response) at Week 16 |
10; 10; 14; 12; 11 | 0.9537 |
| SECONDARY Number of Participants With a 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90 Response) at Week 16 |
3; 5; 7; 7; 2 | 0.4543 |
| SECONDARY Number of Participants Who Achieved a Reduction of ≥ 2 Points From Baseline in the Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) at Week 16 |
8; 7; 8; 10; 9 | 0.6058 |
| SECONDARY Number of Participants Who Achieved a vIGA-AD Response of 0 (Clear) or 1 (Almost Clear) at Week 16 |
5; 5; 6; 8; 6 | 0.7659 |
| SECONDARY Number of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Weekly Averaged Peak Numerical Rating Scale (NRS) for Pruritus Score at Week 16 |
5; 6; 8; 9; 9 | 0.8600 |
| SECONDARY Percent Change From Baseline in Peak Weekly Averaged Numerical Rating Scale (NRS) for Pruritus Score at Week 16 |
-21.13; -22.30; -17.69; -30.39; -27.18 | 0.8927 |
| SECONDARY Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16 |
-37.99; -31.42; -39.22; -35.48; -31.23 | 0.3262 |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 |
-5.61; -5.35; -6.52; -6.05; -5.18 | 0.8497 |
| SECONDARY Number of Participants Who Experienced an Adverse Event (AE) |
38; 40; 41; 42; 43; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03533751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.