A Phase II Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis

• Status: Not yet recruiting
• Trial end date: 2025-05-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akeso

Criteria

Inclusion Criteria:

1. Male or female subjects aged ≥18≤75 years old.

2. Atopic dermatitis (AD) diagnosed at least half a year before screening.

3. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.

4. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months

Exclusion Criteria:

1. Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.

2. Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization

3. Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer)

4. Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.

5. Received allergen specific immunotherapy within the 3 months before randomization.

6. Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.