The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis.
The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis. There is a screening period of up to 2 weeks, an 8-week double-blind treatment period and a 16-week follow-up period after treatment. Patients will receive one dose of CDX-0159 (barzolvolimab) or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
administered intravenously
administered intravenously
Desert Sky Dermatology
Tempe, Arizona, United States
University of Miami, Dermatology Clinical Trials Unit
Miami, Florida, United States
Safety and tolerability as assessed by the incidence and severity of adverse events
Safety and tolerability of multiple dose levels of CDX-0159 as determined by drug related adverse events
Time frame: From Day 1 (first dose) to Day 169 (last follow-up visit)
Pharmacokinetic evaluation
CDX-0159 serum concentrations will be measured at specified visits
Time frame: From Day 1 (before first dose) to Day 169 (last follow-up visit)
Clinical effect of CDX-0159 on pruritus
The mean percent change from baseline to Week 8 in the weekly average score of worst intensity itch per a numeric rating scale. The Worst Itch-Numerical Rating Scale (WI-NRS) ranges from 0 = "no itch" to 10 ="worst imaginable itch" for their worst intensity prurigo nodularis itch in the preceding 24-hr period.
Time frame: From Day 1 (first dose) to Day 57 (week 8)
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Revival Research Institute, LLC
Troy, Michigan, United States
University of New Mexico
Albuquerque, New Mexico, United States
Markowitz Medical/Optiskin
New York, New York, United States
Central Sooner Research
Norman, Oklahoma, United States
Center for Clinical Studies, LTD.LLP
Houston, Texas, United States
Charité Centrum für Innere Medizin und Dermatologie, Institute of Allergology (IFA)
Berlin, Germany
Katholisches Klinikum Bochum gGmbH, Dermatologische Studienambulanz
Bochum, Germany
Universitatsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik fur Dermatologie
Dresden, Germany
...and 7 more locations