The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and the preliminary efficacy of AK101,an anti-IL-12/23p40 monoclonal antibody, when administered subcutaneously 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)..
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Incidence of treatment emergent adverse events (TEAEs)
Time frame: From the time of signing informed consent till Week 16 for Phase I or Week 28 for Phase II
Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75)
Time frame: At Week 2, 4, 8, 12, 16, 20 (Phase II), 24 (Phase II) and 28 (Phase II)
Number of participants who achieved ≥ 90% reduction in PASI (PASI90)
Time frame: At Week 2, 4, 8, 12, 16, 20 (Phase II), 24 (Phase II) and 28 (Phase II)
Change From Baseline in the Physician Global Assessment (PGA)
Time frame: At Week 2, 4, 8, 12, 16, 20 (Phase II), 24 (Phase II) and 28 (Phase II)
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: From first dose till Week 16 for Phase I or Week 28 for Phase II
Area under the curve (AUC) of AK101
The endpoints for assessment of PK of AK101 include serum concentrations of AK101 at different timepoints after AK101 administration.
Time frame: From first dose till Week 16 for Phase I
Minimum observed concentration (Cmin) of AK101
The endpoints for assessment of PK of AK101 include serum concentrations of AK101 at different timepoints after AK101 administration.
Time frame: From first dose till Week 16 for Phase I or Week 28 for Phase II
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Maximum observed concentration (Cmax) of AK101
The endpoints for assessment of PK of AK101 include serum concentrations of AK101 at different timepoints after AK101 administration.
Time frame: From first dose till Week 16 for Phase I or Week 28 for Phase II