NCT06035354

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in Subjects With Atopic Dermatitis

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 427 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.

Detailed description

This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical study to evaluate the safety, pharmacokinetics and efficacy of AK120 in subjects with moderate to severe atopic dermatitis.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	AK120	subcutaneous injection once a week
DRUG	AK120	subcutaneous injection once a week
DRUG	Placebo	subcutaneous injection once a week.
DRUG	AK120	subcutaneous injection every 2 weeks.
DRUG	AK120	subcutaneous injection every 2 weeks.
DRUG	AK120	subcutaneous injection every 2 weeks.
DRUG	Placebo	subcutaneous injection every 2 weeks for 16 weeks then crossover to AK120 Regimen 4 and Regimen 5.
DRUG	AK120	subcutaneous injection every 2 weeks
DRUG	AK120	subcutaneous injection every 2 weeks.
DRUG	AK120	subcutaneous injection every 2 weeks.

Timeline

• Start date: 2021-11-03
• Primary completion: 2024-06-21
• Completion: 2024-06-21
• First posted: 2023-09-13
• Last updated: 2025-03-05

Locations

39 sites across 1 country: China