Status:
COMPLETED
To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis
Lead Sponsor:
Akeso
Conditions:
Psoriasis
Skin Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
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. The study has 2 parts: fi...
Eligibility Criteria
Inclusion
- 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.
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 :
September 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2024
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT06061471
Start Date
September 22 2023
End Date
December 11 2024
Last Update
January 23 2025
Active Locations (11)
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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
Wuhu, Anhui, China
3
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
4
Nanyang First People's hospital national third class a hospital
Nanyang, Henan, China