NCT05120297

A Phase 3 Study of Efficacy and Safety of AK101 in Subjects With Psoriasis

A Study to Evaluate the Efficacy and Safety of AK101 in Subjects With Moderate-to-severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 452 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multicentered phase III clinical study to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to-severe plaque psoriasis.

Detailed description

This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study. The purpose of this study is to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to- severe plaque psoriasis. Subjects will be randomized to receive AK101 or placebo injection subcutaneously, and follow up to week 16.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	AK101	Subjects will receive AK101 subcutaneous injection at week 0 and week 4, and will follow up to week 16.
DRUG	Placebo	Subjects will receive placebo subcutaneous injection at week 0 and week 4, and will follow up to week 16.

Timeline

• Start date: 2021-11-29
• Primary completion: 2022-09-29
• Completion: 2022-09-29
• First posted: 2021-11-15
• Last updated: 2023-03-02

Locations

52 sites across 1 country: China