NCT05155020

A Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AK120 in the Treatment of Subjects With Moderate-to-severe Asthma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (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 II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate-to-severe asthma.

Detailed description

This is a randomized, double-blind, placebo-controlled, multicenter, phase II clinical study. The purpose of this study is to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate-to-severe asthma and not adequately controlled with current stable medium-to-high-dose inhaled glucocorticoids plus up to two additional controllers.Subjects will be randomized to receive AK120 or placebo subcutaneous injection.

Conditions

• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	AK120	AK120 regimen 1-subcutaneous injection every two weeks up to week 24, and follow up to week 32.
BIOLOGICAL	AK120	AK120 regimen 2(first dose doubling)-subcutaneous injection and then every two weeks up to week 24, and follow up to week 32.
BIOLOGICAL	AK120	AK120 regimen 3(first dose doubling)-subcutaneous injection and then every two weeks up to week 24, and follow up to week 32.
BIOLOGICAL	Placebo	Placebo subcutaneous injection every two weeks up to week 24, and follow up to week 32.

Timeline

• Start date: 2022-02-11
• Primary completion: 2022-08-05
• Completion: 2022-08-05
• First posted: 2021-12-13
• Last updated: 2022-10-12

Locations

19 sites across 1 country: China