Open Label Study to Evaluate the Safety and Efficacy of AK101 Injection Subcutaneously in Subjects With Psoriasis

Lab values

• Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection:
  • Subjects who have severe AE or SAE occurred in an Akeso trial with AK101 injection.
  • Subjects who used prohibited drugs in an Akeso trial with AK101 injection.
  • Subjects performed poor compliance in an Akeso trial with AK101 injection, based on the assessment of investigator.
  • Subjects with any other disease, abnormal physical examination or abnormal laboratory examination leading to inapplicable for participating this study, based on the assessment of investigator.
• Applicable for subjects newly enrolled:
  • 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 IL-12/23 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.

• Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection:
  • Subjects can continue to participate in this study based on assessment of investigator.
  • Subjects voluntarily participate in this study.
  • Subjects who are women of childbearing potential must be practicing an adequate, medically acceptable method of birth control during the treatment period and for at least 6 months after the last study drug administration.
• Applicable for subjects newly enrolled:
  • Male or female subjects aged ≥ 18 years old.
  • Subjects diagnosed with moderate-to-severe plaque psoriasis and are applicable to systematic treatment.
  • At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥ 3.
  • Subjects who are applicable for biological agents, based on the assessment of investigator.
  • 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.