This is a Phase IIa, randomised, double-blind, placebo-controlled, multiple dose, multi-center study of AbGn-168H in subjects with moderate to severe chronic plaque psoriasis.The objectives of this study is to investigate efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients with moderate to severe chronic plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Baptist Health Certer for Clinical Research
Little Rock, Arkansas, United States
Northwest AR Clinical Trials
Rogers, Arkansas, United States
PASI75
The primary objective of this study is to investigate efficacy (clinical proof of concept) of AbGn-168H in patients with moderate to severe chronic plaque psoriasis following intravenous administration of multiple doses compared to placebo. In this trial, the high dose and low dose of AbGn-168 and placebo is administered weekly.
Time frame: the achievement of at least 75% reduction from baseline PASI score (PASI75) at week 12 in each patient.
safety and tolerability
Safety measurements including physical examination, vital signs, ECG, clinical laboratory tests and adverse events
Time frame: At different time point for 16 weeks after the first treatment
pharmacokinetics
AUC, Cmax, tmax, t1/2, MRT and Vss; additional parameters as needed
Time frame: At different time point for16 weeks after the first treatment
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