Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2021-11-08
2023-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CDX-0159 1.5mg/kg
CDX-0159 1.5mg/kg administered once
CDX-0159
administered intravenously
CDX-0159 3mg/kg
CDX-0159 3.0 mg/kg administered once
CDX-0159
administered intravenously
Placebo
Normal saline administered once
Normal saline
administered intravenously
Interventions
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CDX-0159
administered intravenously
Normal saline
administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:
1. At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.
2. An Investigators Global Assessment (IGA) score for PN ≥ 3 at screening and Baseline (Day 1).
3. 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.
4. Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
5. Willing to apply a topical moisturizer (emollient) twice daily throughout the study.
6. 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.
7. Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
Exclusion Criteria
2. Unilateral lesions of prurigo (eg, only one arm affected)
3. Active unstable pruritic skin conditions in addition to PN.
4. Women who are pregnant or nursing.
5. Known hepatitis B or hepatitis C infection or active COVID-19 infection
6. 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.
7. History of anaphylaxis.
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
18 Years
75 Years
ALL
No
Sponsors
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Celldex Therapeutics
INDUSTRY
Responsible Party
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Locations
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Desert Sky Dermatology
Tempe, Arizona, United States
University of Miami, Dermatology Clinical Trials Unit
Miami, Florida, United States
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
Universitätsklinikum Frankfurt Klinik für Dermatologie, Venerologie und Allergologie Klinische Forschung
Frankfurt, , Germany
Universitätsklinikum Erlangen Hautklinik
Mainz, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Hautklinik, Clinical Research Center
Mainz, , Germany
Universitaetsklinikum Muenster (UKM) - Klinik für Hautkrankheiten
Münster, , Germany
MT Medic Specjalistyczna Praktyka Lekarska
Krosno, , Poland
IP Clinic Sp. z o.o.
Lodz, , Poland
Centrum Medyczne Ginemedica
Wroclaw, , Poland
Countries
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Other Identifiers
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CDX0159-04
Identifier Type: -
Identifier Source: org_study_id
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