A Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis

This was a single-center, randomized, double-blind, placebo-controlled trial which consisted of a dose escalation phase (Phase I) and a dose expansion phase (Phase II)..

Inclusion criteria

• Have had Plaque Psoriasis diagnosed at least 6 months prior to screening.
• Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area. Psoriasis area and severity index(PASI) ≥12. Physicians Global Assessment score ≥3.
• Patients who have received systemic therapy or phototherapy, or who have been allowed by the investigator to receive systemic therapy or phototherapy.
• Women of childbearing potential should not be in pregnancy or lactation, men and women of childbearing potential must agree to use adequate birth control measures during study participation and for 6 months after the last dose of study treatment.
• Ability to provide written informed consent and to be compliant with the schedule of protocol assessments.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.

Exclusion criteria

• Had nonplaque forms of psoriasis (e.g., Guttate, erythrodermic, or pustular).
• Had other active skin diseases or skin infections (e.g., bacterial, fungal or viral infection) that could affect psoriasis evaluation.
• Had Imaging diagnosis of pulmonary infection or fibrosis during the 3 months prior to screening.
• History or evidence of active or latent tuberculosis at screening.
• Serious systemic infections or local infections during the 2 months prior to screening.
• History of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
• Known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
• History of alcohol or drug abuse.
• History or known presence of recurrent or chronic infection (e.g., hepatitis B, or C, human immunodeficiency virus [HIV], syphilis, TB).
• Had received any DMARDs (e.g., anti-malaria drug, retinoids, interferon, lithium) during 2 weeks prior to screening.
• Had received any physical therapy (e.g., PUVA, ultra-violet therapy, tanning beds) during 2 weeks prior to screening.
• Had received any systemic psoriasis therapy (e.g., glucocorticoid, retinoids, ciclosporin, methotrexate, or tripterygium) during 4 weeks prior to screening.
• Had Enrolled in any other trials during 3 months prior to screening or concurrently enrolled in any other trials.
• Had received previous treatment with any anti-IL-12/IL-23, IL-12, IL-23, IL-17 therapy for the treatment of psoriasis or psoriatic arthritis.
• Had received previous treatment with natalizumab or any other drugs that regulate B cells or T cells (rituximab, abatacept, alemtuzumab) during 12 months prior to screening.
• Had received other biologic therapy (e.g., TNF inhibitor) during 6 months prior to screening.