Not yet recruiting NCT07502222
A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate-to-severe Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK139 and placebo, AK139, AK139 and placebo, AK139.
- Who it may be relevant to
- Registry conditions: Moderate-to-Severe Atopic Dermatitis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AK139 in Patients With Moderate to Severe Atopic Dermatitis
Overview
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.
Interventions
- Biological AK139 and placebo
AK139 plus placebo regimen 1-subcutaneous injection. - Biological AK139
AK139 regimen 2-subcutaneous injection. - Biological AK139 and placebo
AK139 plus placebo regimen 3-subcutaneous injection. - Biological AK139
AK139 regimen 4-subcutaneous injection. - Biological AK139 and placebo
AK139 plus placebo regimen 5-subcutaneous injection. - Biological AK139 and placebo
AK139 plus placebo regimen 6-subcutaneous injection. - Biological Placebo
Placebo-subcutaneous injection
Primary outcome measures
- Incidence and severity grading of Adverse Events (AE)(applicable to Part 1) [Time frame: Up to Week 16 (applicable to the Q4W dosing group); Up to Week 8 (applicable to the Q2W dosing group).]
- Percentage of patients who achieved Eczema Area and Severity Index (EASI)-75 (applicable to Part 2) [Time frame: at week 16]
Secondary outcome measures (4)
- Percentage of patients achieving an IGA score of 0 or 1 at each visit, with a reduction of ≥2 points from baseline [Time frame: Up to Week 24]
- Percentage change in affected Body Surface Area (BSA) [Time frame: Up to week 24]
- Percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores [Time frame: Up to week 24]
- Percentage changes in the Dermatology Life Quality Index (DLQI) score [Time frame: Up to week 24]
Eligibility criteria
Inclusion criteria
- Able to understand the study and voluntarily sign the ICF.
- Atopic dermatitis (AD) diagnosed at least 6 months before screening.
- 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.
- A weekly average of daily Peak Pruritus Numerical Rating Scale (P-NRS) score ≥4 at baseline.
- Inadequate response or intolerance to prior topical therapy for AD.
- 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
- Acute onset of AD within the first 4 weeks of randomization.
- Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy or other systemic therapies used for AD within the 4 weeks before randomization.
- Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
- Received or planned to receive live vaccine treatment within the 12 weeks before randomization or during the study period.
- Received allergen specific immunotherapy within the 12 weeks before randomization.
- Have a history of allergies to any component of AK139 and/or severe allergic reactions to monoclonal antibodies.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07502222 · AK139-205