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NCT07502222Not yet recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 30 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
168 (estimated)
First submitted
25 Mar 2026
Start date
Apr 2026
Primary completion date
Nov 2027
Lead sponsor
Akeso
NCT number
NCT07502222

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 168
  • From Apr 2026 to the primary completion date, Nov 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Have a history of allergies to any component of AK139 and/or severe allergic reactions to monoclonal antibodies.

Other

  • Acute onset of AD within the first 4 weeks of randomization.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.