Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Akeso
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.
Detailed Description
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total dur...
Eligibility Criteria
Inclusion
- Male or female subjects aged ≥18≤75 years old.
- Atopic dermatitis (AD) diagnosed at least half a year before screening.
- Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
- Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months
Exclusion
- Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
- Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization
- Received treatment with other clinical study drugs within 1 month or 5 half-lives before 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.
Key Trial Info
Start Date :
November 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06092762
Start Date
November 6 2023
End Date
November 13 2024
Last Update
November 25 2024
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
2
Air Force Medical Center
Beijing, Beijing Municipality, China
3
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
4
Peking University Third Hospital
Beijing, Beijing Municipality, China