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

Study Overview
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Brief Summary
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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
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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 duration of the study (including screening period) planned for each subject is approximately 29 weeks.

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: AK120


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AK120 300mg<br>AK120 loading dose 600mg, then 300mg subcutaneous injection every 2 weeks thereafter until week 14. | Drug: AK120<br>* subcutaneous injection every 2 weeks<br>|
| Experimental: AK120 450mg<br>AK120 loading dose 600mg, then 450mg subcutaneous injection every 2 weeks thereafter until week 14. | Drug: AK120<br>* subcutaneous injection every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events(AE) | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment | week 0 to week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75 |  | at week 2/4/8/12/16 /20 and 24 | 
| Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-50 |  | at week 2/4/8/12/16 /20 and 24 | 
| Percentage change in (Eczema Area and Severity Index) EASI scores from baseline |  | at week 2/4/8/12/16 /20 and 24 | 
| Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA |  | at week 2/4/8/12/16 /20 and 24 | 
| Percentage of subjects with a (Investigator's Global Assessment) IGA score decrease of ≥ 2 points from baseline |  | at week 2/4/8/12/16 /20 and 24 | 
| Percentage change in (affected body surface area) BSA score from baseline |  | at week 2/4/8/12/16 /20 and 24 |