Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis
Lead Sponsor:
Akeso
Conditions:
Psoriasis
Skin Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque ps...
Detailed Description
This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with moderate to severe plaque ps...
Eligibility Criteria
Inclusion
- Male or female subjects aged ≥18 years old.
- Subjects diagnosed with moderate to severe plaque psoriasis with or without psoriatic arthritis.
- At screening and baseline, PASI score ≥ 12 , Body Surface Area(BSA) ≥ 10%, sPGA ≥ 3.
- Suitable for systematic therapy assessed by investigators.
- Subjects who are women of childbearing potential must have a negative pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control during the study and for at least 6 months after the last study drug administration.
Exclusion
- Types of psoriasis other than chronic plaque-type psoriasis.
- Drug-induced psoriasis.
- Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
- Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
- History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.
- Progressive or uncontrolled symptoms or signs of circulatory, respiratory, digestive, neuropsychiatric or psychological, hematological, endocrine and other systems before randomization.
- History of malignant tumour within 5 years before screening.
- Previous or current autoimmune diseases.
- Allergic to any component of the investigational drug, or have had severe allergic reactions to monoclonal antibodies.
Key Trial Info
Start Date :
March 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2024
Estimated Enrollment :
351 Patients enrolled
Trial Details
Trial ID
NCT06066125
Start Date
March 31 2023
End Date
August 19 2024
Last Update
February 20 2025
Active Locations (34)
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1
The first affiliated hospital of Bengbu Medical College
Bengbu, Anhui, China
2
The first affiliated hospital of wannan medical college
Wannan, Anhui, China
3
Affiliated hospital of Chongqing Three Gorges Medical College
Chongqing, Chongqing Municipality, China
4
Chongqing traditional Chinese medicine hospital (Daomenkou branch)
Chongqing, Chongqing Municipality, China