A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis
- Registration Number
- NCT06383468
- Lead Sponsor
- Akeso
- Brief Summary
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis.
- Detailed Description
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis. The entire study included a screening period, a double-blind controlled treatment period, a conversion and maintenance treatment period, and a safe follow-up period.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 420
- Male or female subjects aged ≥18≤75 years old.
- Atopic dermatitis (AD) diagnosed at least 1 year before screening.
- Subject with eczema area and severity index (EASI) score ≥16, Investigator Global Assessment (IGA) score≥ 3, Body Surface Area (BSA) score ≥ 10% at screening and baseline.
- Previously received at least 4 weeks of moderate to strong or at least 2 weeks of strong local glucocorticoid (TCS) treatment for AD before screening, with poor efficacy or intolerable
- Acute onset of AD within the first 4 weeks of randomization.
- Have participated in any clinical research on AK120 in the past
- Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
- Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
- Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
- Received allergen specific immunotherapy within the 3 months before randomization.
- Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AK120 600mg/300mg AK120 AK120 600mg(first day) then 300mg Q2W subcutaneous injection thereafter until week 50. Placebo/AK120 600mg to 300mg AK120 placebo Q2W SC, then AK120 600mg at week 16, thereafter change to AK120 300mg Q2W subcutaneous injection until week 50.
- Primary Outcome Measures
Name Time Method Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75 at week 16 Percentage of patients in both treatment group and placebo group who achieved EASI 75 at week 16.
- Secondary Outcome Measures
Name Time Method Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA at week 16 The percentage of patients in both treatment group and placebo group who achieved IGA 0/1 score at week 16.
Trial Locations
- Locations (59)
Beijing Friendship Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Luhe Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Tongren Hospital
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Chongqing Three Gorges Medical College Affiliated People's Hospital
🇨🇳Chongqing, Chongqing, China
Chongqing Traditional Chinese Medicine Hospital
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
The Second Affiliated Hospital of Xiamen Medical College
🇨🇳Xiamen, Fujian, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
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