A Phase 3 Study of Efficacy and Safety of AK101 in Subjects With Psoriasis

This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study. The purpose of this study is to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to- severe plaque psoriasis. Subjects will be randomized to receive AK101 or placebo injection subcutaneously, and follow up to week 16.

Inclusion criteria

• Male or female subjects aged ≥ 18 years.
• Subjects diagnosed with moderate-to-severe plaque psoriasis for at least 6 months before screening.
• At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥ 3.
• Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
• 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 for at least 6 months after the last study drug administration.

Exclusion criteria

• Forms of psoriasis other than chronic plaque-type psoriasis.
• History or 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.
• History of prohibited psoriasis treatments within 2/4 weeks before randomization.
• History of IL12/23 or IL-23 inhibitors therapy.
• Inadequate washout period of prior biological therapy.
• History of malignant tumour within 5 years before screening.
• Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator would place the subject at risk, interfere with participation or interpretation of the study.