Moderate-to-Severe Atopic Dermatitis
Conditions
Brief summary
This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of patients with moderate-to-severe atopic dermatitis.
Interventions
BIOLOGICALAK139 and placebo
AK139 plus placebo regimen 1-subcutaneous injection.
BIOLOGICALAK139
AK139 regimen 2-subcutaneous injection.
BIOLOGICALPlacebo
Placebo-subcutaneous injection
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Able to understand the study and voluntarily sign the ICF. 2. Atopic dermatitis (AD) diagnosed at least 6 months before screening. 3. Eczema Area and Severity Index (EASI) score ≥16, Investigator's Global Assessment (IGA) score ≥3, and Body surface area (BSA) involvement ≥10% at both screening and baseline. 4. A weekly average of daily Peak Pruritus Numerical Rating Scale (P-NRS) score ≥4 at baseline. 5. Inadequate response or intolerance to prior topical therapy for AD. 6. The patients agree to use highly effective contraception methods from the moment of signing of the ICF to 90 days after the last dose of the investigational product.
Exclusion criteria
1. Acute onset of AD within the first 4 weeks of randomization. 2. Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy or other systemic therapies used for AD within the 4 weeks before randomization. 3. Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer) 4. Received or planned to receive live vaccine treatment within the 12 weeks before randomization or during the study period. 5. Received allergen specific immunotherapy within the 12 weeks before randomization. 6. Have a history of allergies to any component of AK139 and/or severe allergic reactions to monoclonal antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity grading of Adverse Events (AE)(applicable to Part 1) | Up to Week 16 (applicable to the Q4W dosing group); Up to Week 8 (applicable to the Q2W dosing group). |
| Percentage of patients who achieved Eczema Area and Severity Index (EASI)-75 (applicable to Part 2) | at week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving an IGA score of 0 or 1 at each visit, with a reduction of ≥2 points from baseline | Up to Week 24 |
| Percentage change in affected Body Surface Area (BSA) | Up to week 24 |
| Percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores | Up to week 24 |
| Percentage changes in the Dermatology Life Quality Index (DLQI) score | Up to week 24 |
Contacts
CONTACTGuoqin Wang
Outcome results
None listed