NCT05096364

A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 for the treatment of moderate to severe plaque psoriasis.

Detailed description

This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 in subjects with moderate to severe plaque psoriasis. The study will consist of 4 periods: up to 4 weeks screening period, 12 weeks placebo-controlled period,12 weeks crossover treatment period,44 weeks long-term treatment period.

Conditions

• Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	AK111/Placebo	After loading dose, investigational drug was administered subcutaneously up to 60 weeks.

Timeline

• Start date: 2021-04-28
• Primary completion: 2023-02-03
• Completion: 2023-02-03
• First posted: 2021-10-27
• Last updated: 2025-02-28

Locations

13 sites across 1 country: China