NCT05509361

Open Label Study to Evaluate the Safety and Efficacy of AK101 Injection Subcutaneously in Subjects With Psoriasis

An Open-label, Single-arm, Multi-center Study to Evaluate the Long-term Safety and Efficacy of AK101 Injection in Subjects With Moderate-to-severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 950 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label Phase III clinical study to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis.

Detailed description

This is an open-label, single-arm, multi-center phase III study. The purpose of this study is to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis. Subjects who have completed the previous Akeso registration trial with AK101 injection (AK101-302) and subjects who are to be newly enrolled will both receive AK101 135mg injection subcutaneously.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	AK101 injection SC	AK101 is supplied as 135 mg doses, provided in 1 mL prefilled syringes.

Timeline

• Start date: 2022-04-08
• Primary completion: 2023-11-24
• Completion: 2023-11-24
• First posted: 2022-08-22
• Last updated: 2024-06-04

Locations

1 site across 1 country: China