NCT07502222

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for phase_2

Timeline
19mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Jan 2028

First Submitted

Initial submission to the registry

March 25, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

April 7, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

March 25, 2026

Last Update Submit

March 25, 2026

Conditions

Moderate-to-Severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

  • Incidence and severity grading of Adverse Events (AE)(applicable to Part 1)

    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)

    at week 16

Secondary Outcomes (4)

  • Percentage of patients achieving an IGA score of 0 or 1 at each visit, with a reduction of ≥2 points from baseline

    Up to Week 24

  • Percentage change in affected Body Surface Area (BSA)

    Up to week 24

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

    Up to week 24

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

    Up to week 24

Study Arms (7)

Part 1: AK139 regimen 1

EXPERIMENTAL
Biological: AK139 and placebo

Part 1: AK139 regimen 2

EXPERIMENTAL
Biological: AK139

Part 1: AK139 regimen 3

EXPERIMENTAL
Biological: AK139 and placebo

Part 1: AK139 regimen 4

EXPERIMENTAL
Biological: AK139

Part 2: AK139 regimen 5

EXPERIMENTAL
Biological: AK139 and placebo

Part 2: AK139 regimen 6

EXPERIMENTAL
Biological: AK139 and placebo

Part 2: Placebo

PLACEBO COMPARATOR
Biological: Placebo

Interventions

AK139 and placeboBIOLOGICAL

AK139 plus placebo regimen 1-subcutaneous injection.

Part 1: AK139 regimen 1
AK139BIOLOGICAL

AK139 regimen 2-subcutaneous injection.

Part 1: AK139 regimen 2
PlaceboBIOLOGICAL

Placebo-subcutaneous injection

Part 2: Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Guoqin Wang

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2026

First Posted

March 30, 2026

Study Start

April 7, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

January 10, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share