This is a Phase Ib clinical study of multiple dose escalation of AK111 in subjects with moderate-to-severe plaque psoriasis
This is a randomized, double-blind, placebo-controlled phase Ib clinical study. This study aims to determine the safety, tolerance, pharmacokinetics(PK) and Pharmacodynamics (PD) characteristics, immunogenicity and preliminary clinical efficacy of multiple dose escalation administration of AK111 in subjects with moderate-to-severe plaque psoriasis..
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
AkesoBio Investigative Site 1002
Bengbu, Anhui, China
AkesoBio Investigative Site 1001
Beijing, China
Assessment of Safety
Incidence of treatment emergent adverse events (TEAE), serious adverse events (SAE).
Time frame: Baseline till Week 20
PK evaluation: T1/2
Assessment of elimination half-life (T1/2) after AK111 administration.
Time frame: Baseline till week 20
PK evaluation: AUC
Assessment of area under curve (AUC) after AK111 administration.
Time frame: Baseline till week 20
PK evaluation: Cmax
Assessment of maximum plasma concentration (Cmax) after AK111 administration.
Time frame: Baseline till week 20
PK evaluation: Tmax
Assessment of time to maximum plasma concentration (Tmax) after AK111 administration.
Time frame: Baseline till week 20
PASI 75
Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 75 response which means whose PASI score decrease at least 75 percent compared with baseline at week 12. PASI is a measure of overall psoriasis severity and coverage. The PASI score is in the range of 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).
Time frame: At week 12
PASI 90
Proportion of subjects who achieve PASI 90 response which means whose PASI score decrease at least 90 percent compared with baseline at week 12. PASI is a measure of overall psoriasis severity and coverage. The PASI score is in the range of 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At week 12
PASI 100
Proportion of subjects who achieve PASI 100 response which means whose PASI score decrease 100 percent compared with baseline at week 12. PASI is a measure of overall psoriasis severity and coverage. The PASI score is in the range of 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).
Time frame: At week 12
sPGA 0/1
Proportion of subjects who achieve Static Physicians Global Assessment (sPGA) 0/1 which means whose sPGA score is clear or almost-clear at week 12. The sPGA is a measure of global assessment of the patient's overall severity, which could be converted to numerals ranging from 0 to 5 (clear = 0, almost-clear = 1, mild = 2, moderate = 3, marked = 4, and severe = 5).
Time frame: At week 12
Immunogenicity
Proportion of subjects with detectable anti-drug antibody (ADA).
Time frame: Baseline till week 20