Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03533751 | Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis | PHASE2 | COMPLETED | 302 | — | — | Jun 19, 2018 | Dec 3, 2019 | May 24, 2023 | 81 | United States, Canada +4 |
EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks. |
| Etokimab 20 mg SC Q4W | EXPERIMENTAL | Participants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks. |
| Etokimab 300 mg load + 150 mg SC Q8W | EXPERIMENTAL | 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. |
| Etokimab 300 mg load + 150 mg SC Q4W | EXPERIMENTAL | Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks. |
| Etokimab 600 mg load + 300 mg SC Q4W | EXPERIMENTAL | Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. |
| Name | Type | Description |
|---|---|---|
| Etokimab | BIOLOGICAL | Humanized monoclonal antibody, administered by subcutaneous injection |
| Placebo | DRUG | Administered by subcutaneous injection |
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) s...