The purpose of this study is to evaluate the safety and tolerability of XmAb27564 following multiple doses among participants with plaque psoriasis and atopic dermatitis.
This is a phase 1b, randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study of XmAb27564. It is planned to enroll approximately 48 adult patients with mild-to-severe plaque psoriasis and 80 adult patients with moderate-to-severe atopic dermatitis. All patients will receive a total of 4 doses of study drug or placebo, administered subcutaneously every 2 weeks. A one year, open-label extension is available to qualifying patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
Unison Clinical Trials
Sherman Oaks, California, United States
Clinical Trials Research Institute
Thousand Oaks, California, United States
Driven Research
Coral Gables, Florida, United States
San Marcus Research Clinic
Miami Lakes, Florida, United States
To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564
Safety and tolerability will be assessed by incidence of AE's; incidence of clinically significant changes in physical exams, vital signs, ECGs, and clinical laboratory testing; incidence of DLT's
Time frame: Day 57
To characterize pharmacokinetics
Pharmacokinetics will be assessed by serum XmAb27564 concentrations
Time frame: Day 57
To characterize pharmacodynamics
Pharmacodynamics will be assessed by the change in number of regulatory T cells, conventional T cells, and natural killer cells (NK cells) in blood
Time frame: Day 57
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J&S Studies, Inc
College Station, Texas, United States
Center for Clinical Studies, LTD. LLP
Webster, Texas, United States
Innovaderm Research Inc.
Montreal, Quebec, Canada