This is a multiple-center, randomized, double-blind, placebo-controlled Phase IIb study to evaluate the efficacy and safety of AK101, an anti-IL-12/23 p40 antibody, when administered subcutaneously, in subjects with moderate-to-severe plaque psoriasis. The study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blinded treatment and long-term follow-up period(up to 52 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
330
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75) at Week 12
Time frame: Week 12
Incidence of treatment emergent adverse events (TEAEs)
Time frame: From the time of signing the informed consent form till last follow-up visit (Up to Week 52)
Number of participants who achieved ≥ 90% reduction in Psoriasis Area and Severity Index (PASI90) at Week 12
Time frame: At baseline and Week 12
Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75)
Time frame: Up to Week 52 (except for Week 12)
Number of participants who achieved ≥ 90% reduction in Psoriasis Area and Severity Index (PASI90)
Time frame: Up to Week 52( except for Week 12)
Number of participants who achieved 100% reduction in Psoriasis Area and Severity Index (PASI100) at Week 12
Time frame: Up to Week 52
Proportion of subjects who achieve a ≥ 4-point reduction in DLQI from baseline
The DLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a participant's QoL. It is a 10-item questionnaire that, in addition to evaluating overall Qol, can be used to assess six different aspects that mey affect QoL: 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment.
Time frame: Up to Week 52
Proportion of subjects who achieve Physician Global Assessment (PGA) of clear or almost clear (0 or 1) after treatment
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Time frame: Up to Week 52
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK101 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: Up to Week 52
Minimum observed concentration (Cmin) of AK101 at steady state
Time frame: Up to Week 52