Overview
A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2024-10-01
2024-10-01
Target enrollment:
0
0
Participant gender:
All
All
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 psoriasis.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Akeso
Criteria
Inclusion Criteria:1. Male or female subjects aged ≥18 years old.
2. Subjects diagnosed with moderate to severe plaque psoriasis with or without psoriatic
arthritis.
3. At screening and baseline, PASI score ≥ 12 , Body Surface Area(BSA) ≥ 10%, sPGA ≥ 3.
4. Suitable for systematic therapy assessed by investigators.
5. 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 Criteria:
1. Types of psoriasis other than chronic plaque-type psoriasis.
2. Drug-induced psoriasis.
3. Evidence of active TB. Patients with evidence of latent tuberculosis may enter the
trial after sufficient treatment had initiated and maintained according to protocol.
4. Positive results of confirmatory test for hepatitis B, hepatitis C, human
immunodeficiency virus (HIV) or syphilis.
5. History of repeated chronic infection, had any serious infection or systemic infection
within 2 months before screening.
6. Progressive or uncontrolled symptoms or signs of circulatory, respiratory, digestive,
neuropsychiatric or psychological, hematological, endocrine and other systems before
randomization.
7. History of malignant tumour within 5 years before screening.
8. Previous or current autoimmune diseases.
9. Allergic to any component of the investigational drug, or have had severe allergic
reactions to monoclonal antibodies.