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

Akeso

Status and phase: Enrolling; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: AK120

Study type: Interventional

Funder types: Industry

Identifiers

NCT06383468

AK120-301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects aged ≥18≤75 years old.
2. Atopic dermatitis (AD) diagnosed at least 1 year before screening.
3. 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.
4. 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

Exclusion criteria

1. Acute onset of AD within the first 4 weeks of randomization.
2. Have participated in any clinical research on AK120 in the past
3. Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
4. Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
5. Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
6. Received allergen specific immunotherapy within the 3 months before randomization.
7. Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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420 participants in 2 patient groups, including a placebo group

AK120 600mg/300mg

Experimental group

Description:

AK120 600mg(first day) then 300mg Q2W subcutaneous injection thereafter until week 50.

Treatment:

Drug: AK120

Placebo/AK120 600mg to 300mg

Placebo Comparator group

Description:

placebo Q2W SC, then AK120 600mg at week 16, thereafter change to AK120 300mg Q2W subcutaneous injection until week 50.

Treatment:

Drug: AK120