NCT07502222

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Moderate-to-Severe Atopic Dermatitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-07
• Primary completion: 2027-11-01
• Completion: 2028-01-10
• First posted: 2026-03-30
• Last updated: 2026-03-30