A Study of CDX-0159 in Patients With Prurigo Nodularis
- Conditions
- Prurigo Nodularis
- Interventions
- Biological: CDX-0159Drug: Normal saline
- Registration Number
- NCT04944862
- Lead Sponsor
- Celldex Therapeutics
- Brief Summary
The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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Males and females, 18 - 75 years old.
-
Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:
- At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.
- An Investigators Global Assessment (IGA) score for PN ≥ 3 at screening and Baseline (Day 1).
-
Severe itch, defined as the mean of the daily worst itch NRS (WI-NRS) score of ≥ 7 during the 7-day period immediately prior to initiation of study treatment.
-
Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
-
Willing to apply a topical moisturizer (emollient) twice daily throughout the study.
-
Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment.
-
Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
Key
- PN due to neuropathy, psychiatric disorders or medications.
- Unilateral lesions of prurigo (eg, only one arm affected)
- Active unstable pruritic skin conditions in addition to PN.
- Women who are pregnant or nursing.
- Known hepatitis B or hepatitis C infection or active COVID-19 infection
- Vaccination with a live vaccine within 2 months prior to study drug administration (subjects must agree to avoid vaccination during the study and for four months thereafter). NOTE: Inactivated vaccines are allowed such as seasonal influenza for injection. COVID-19 vaccination is allowed.
- History of anaphylaxis.
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CDX-0159 1.5mg/kg CDX-0159 CDX-0159 1.5mg/kg administered once CDX-0159 3mg/kg CDX-0159 CDX-0159 3.0 mg/kg administered once Placebo Normal saline Normal saline administered once
- Primary Outcome Measures
Name Time Method Safety and tolerability as assessed by the incidence and severity of adverse events From Day 1 (first dose) to Day 169 (last follow-up visit) Safety and tolerability of multiple dose levels of CDX-0159 as determined by drug related adverse events
- Secondary Outcome Measures
Name Time Method Pharmacokinetic evaluation From Day 1 (before first dose) to Day 169 (last follow-up visit) CDX-0159 serum concentrations will be measured at specified visits
Clinical effect of CDX-0159 on pruritus From Day 1 (first dose) to Day 57 (week 8) 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.
Trial Locations
- Locations (17)
Markowitz Medical/Optiskin
🇺🇸New York, New York, United States
Revival Research Institute, LLC
🇺🇸Troy, Michigan, United States
MT Medic Specjalistyczna Praktyka Lekarska
🇵🇱Krosno, Poland
Katholisches Klinikum Bochum gGmbH, Dermatologische Studienambulanz
🇩🇪Bochum, Germany
Charité Centrum für Innere Medizin und Dermatologie, Institute of Allergology (IFA)
🇩🇪Berlin, Germany
Desert Sky Dermatology
🇺🇸Tempe, Arizona, United States
Center for Clinical Studies, LTD.LLP
🇺🇸Houston, Texas, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Universitatsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik fur Dermatologie
🇩🇪Dresden, Germany
Universitätsklinikum Frankfurt Klinik für Dermatologie, Venerologie und Allergologie Klinische Forschung
🇩🇪Frankfurt, Germany
Universitätsklinikum Erlangen Hautklinik
🇩🇪Mainz, Germany
Universitaetsklinikum Muenster (UKM) - Klinik für Hautkrankheiten
🇩🇪Münster, Germany
Centrum Medyczne Ginemedica
🇵🇱Wrocław, Poland
IP Clinic Sp. z o.o.
🇵🇱Łódź, Poland
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Hautklinik, Clinical Research Center
🇩🇪Mainz, Germany
University of Miami, Dermatology Clinical Trials Unit
🇺🇸Miami, Florida, United States