This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and immunogenicity of CC-90006 following administration of multiple subcutaneous doses in subjects with mild to moderate plaque-type psoriasis.
The study will be conducted in subjects with mild to moderate plaque-type psoriasis. The study will consist of escalating multiple (three) doses in sequential groups. Approximately 40 subjects with plaque-type psoriasis will be enrolled into approximately 4 planned dose cohorts. Each cohort will study a different CC-90006 dose level and have ten subjects; eight subjects will receive CC-90006 and two subjects will receive placebo. Subjects will be dosed according to a computer-generated randomization scheme. Dosing will occur on Days 1, 15 (Week 2), and 29 (Week 4). During the study, blood samples and punch biopsies will be collected to determine the amount of CC-90006 in the body and to evaluate its effect on the subject's condition. Subjects will return to the clinic for regular follow up visits for safety, PK, and PD. A follow up phone call to each subject to determine general health will occur on Day 141 (week 20).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Anaheim Clinical Trials, LLC
Anaheim, California, United States
TKL Research
Fair Lawn, New Jersey, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Innovaderm Research
Montreal, Quebec, Canada
Adverse Events (AEs)
Number of participants with adverse events
Time frame: Up to approximately Week 20
Pharmacokinetics: Cmax
Observed maximum concentration of CC-90006 in serum
Time frame: Up to approximately 16 weeks
Pharmacokinetics - Tmax
Time to reach the observed maximum concentration of CC-90006 in serum
Time frame: Up to approximately 16 weeks
Pharmacokinetics - AUC 0-t
Area under that serum-concentration time curve calculated from time zero to the last measured time point
Time frame: Up to approximately 16 weeks
Pharmacokinetics - AUC 0-∞
Area under that serum-concentration time curve calculated from time zero to ∞
Time frame: Up to approximately 16 weeks
Pharmacokinetics - t1/2
Terminal elimination half-life
Time frame: Up to approximately 16 weeks
Pharmacokinetics - CL/F
Apparent clearance of drug from serum after extravascular administration
Time frame: Up to approximately 16 weeks
Pharmacokinetics - Vz/F
Apparent volume of distribution during the terminal phase
Time frame: Up to approximately 16 weeks
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Pharmacokinetics - Rac [AUCτ]
Accumulation ratio based on Cmax (Rac \[Cmax\]) and AUCτ
Time frame: Up to approximately 16 weeks
Fraction of subjects with Anti-drug antibody (ADA)
Measure of the body's immune response to CC-90006
Time frame: Up to approximately 16 weeks