A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate-to-severe Atopic Dermatitis

Akeso

Status and phase: Not yet enrolling; Phase 2

Conditions: Moderate-to-Severe Atopic Dermatitis

Treatments: Biological: AK139; Biological: AK139 and placebo; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07502222

AK139-205

Details and patient eligibility

About

This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of patients with moderate-to-severe atopic dermatitis.

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able to understand the study and voluntarily sign the ICF.
2. Atopic dermatitis (AD) diagnosed at least 6 months before screening.
3. Eczema Area and Severity Index (EASI) score ≥16, Investigator's Global Assessment (IGA) score ≥3, and Body surface area (BSA) involvement ≥10% at both screening and baseline.
4. A weekly average of daily Peak Pruritus Numerical Rating Scale (P-NRS) score ≥4 at baseline.
5. Inadequate response or intolerance to prior topical therapy for AD.
6. The patients agree to use highly effective contraception methods from the moment of signing of the ICF to 90 days after the last dose of the investigational product.

Exclusion criteria

1. Acute onset of AD within the first 4 weeks of randomization.
2. Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy or other systemic therapies used for AD within the 4 weeks before randomization.
3. Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
4. Received or planned to receive live vaccine treatment within the 12 weeks before randomization or during the study period.
5. Received allergen specific immunotherapy within the 12 weeks before randomization.
6. Have a history of allergies to any component of AK139 and/or severe allergic reactions to monoclonal antibodies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 7 patient groups, including a placebo group

Part 1: AK139 regimen 1

Experimental group

Treatment:

Biological: AK139 and placebo

Biological: AK139 and placebo

Biological: AK139 and placebo

Biological: AK139 and placebo

Part 1: AK139 regimen 2

Experimental group

Treatment:

Biological: AK139

Biological: AK139

Part 1: AK139 regimen 3

Experimental group

Treatment:

Biological: AK139 and placebo

Biological: AK139 and placebo

Biological: AK139 and placebo

Biological: AK139 and placebo

Part 1: AK139 regimen 4

Experimental group

Treatment:

Biological: AK139

Biological: AK139

Part 2: AK139 regimen 5

Experimental group

Treatment:

Biological: AK139 and placebo

Biological: AK139 and placebo

Biological: AK139 and placebo

Biological: AK139 and placebo

Part 2: AK139 regimen 6

Experimental group

Treatment:

Biological: AK139 and placebo

Biological: AK139 and placebo

Biological: AK139 and placebo

Biological: AK139 and placebo

Part 2: Placebo

Placebo Comparator group

Treatment:

Biological: Placebo