A Randomized, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of AK111 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis
Status: Completed
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque psoriasis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female subjects aged ≥18 years old.
• Subjects with moderate to severe plaque psoriasis with or without psoriatic arthritis.
• At screening and baseline, PASI score ≥ 12, BSA ≥ 10%, sPGA ≥ 3.
• Suitable for systematic therapy assessed by investigators.
• Subjects who are women of childbearing potential must be practicing an adequate, medically acceptable method of birth control during the study and for at least 6 months after the last investigational drug administration.
Locations
Other Locations
China
The First Affiliated Hospital of Bengbu Medical College
Bengbu
The Third Xiangya Hospital of Central South University
Changsha
Affiliated Hospital of Chengde Medical University
Chengde
Hangzhou First People's hospital
Hangzhou
The first hospital of Jiaxing
Jiaxing
Dermatology hospital of Jiangxi province
Nanchang
Nanyang First People's hospital national third class a hospital
Nanyang
Tianjin academy of traditional Chinese medicine affiliated hospital
Tianjin
The First Affiliated Hospital of Wannan Medical College
Wuhu
The affiliated hospital of Xuzhou Medical University
Xuzhou
Yichang central People's hospital
Yichang
Time Frame
Start Date: 2023-09-22
Completion Date: 2024-12-11
Participants
Target number of participants: 454
Treatments
Experimental: Experimental: AK111 regimen 1
Experimental: Experimental: AK111 regimen 2
Related Therapeutic Areas
Sponsors
Leads: Akeso