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Not yet recruitingNCT07502222Updated Mar 30, 2026

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

A Phase 2 interventional study of AK139 and placebo and AK139 in Moderate-to-Severe Atopic Dermatitis, sponsored by Akeso. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Akeso · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Moderate-to-Severe Atopic Dermatitis
03

In context

Lead sponsor

Akeso is the lead sponsor of 154 studies on the registry; 67 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
168 participants (estimated)

Study arms

  • Experimental
    Part 1: AK139 regimen 1

    Biological: AK139 and placebo

  • Experimental
    Part 1: AK139 regimen 2

    Biological: AK139

  • Experimental
    Part 1: AK139 regimen 3

    Biological: AK139 and placebo

  • Experimental
    Part 1: AK139 regimen 4

    Biological: AK139

  • Experimental
    Part 2: AK139 regimen 5

    Biological: AK139 and placebo

  • Experimental
    Part 2: AK139 regimen 6

    Biological: AK139 and placebo

  • Placebo comparator
    Part 2: Placebo

    Biological: Placebo

Interventions

  • BiologicalAK139 and placebo

    AK139 plus placebo regimen 1-subcutaneous injection.

  • BiologicalAK139

    AK139 regimen 2-subcutaneous injection.

  • BiologicalAK139 and placebo

    AK139 plus placebo regimen 3-subcutaneous injection.

  • BiologicalAK139

    AK139 regimen 4-subcutaneous injection.

  • BiologicalAK139 and placebo

    AK139 plus placebo regimen 5-subcutaneous injection.

  • BiologicalAK139 and placebo

    AK139 plus placebo regimen 6-subcutaneous injection.

  • BiologicalPlacebo

    Placebo-subcutaneous injection

06

What researchers measure

Primary outcomes

  1. 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).

  2. Percentage of patients who achieved Eczema Area and Severity Index (EASI)-75 (applicable to Part 2)

    Time frame: at week 16

Secondary outcomes

  1. 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

  2. Percentage change in affected Body Surface Area (BSA)

    Time frame: Up to week 24

  3. Percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores

    Time frame: Up to week 24

  4. Percentage changes in the Dermatology Life Quality Index (DLQI) score

    Time frame: Up to week 24

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07502222
Lead sponsor
Akeso
Responsible party
Sponsor
First posted
Mar 30, 2026
Start date
Apr 7, 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Jan 10, 2028 (estimated)
Last update
Mar 30, 2026

Study contacts

Guoqin Wang
Contact
global.trials@akesobio.com
+86 (0760) 8987 3999

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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