Back to resultsA Study of CDX-0159 in Patients With Prurigo Nodularis
Primary Purpose
Prurigo Nodularis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CDX-0159
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Prurigo Nodularis focused on measuring CDX-0159, barzolvolimab
Eligibility Criteria
Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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.
Sites / Locations
- Desert Sky Dermatology
- University of Miami, Dermatology Clinical Trials Unit
- Revival Research Institute, LLC
- University of New Mexico
- Markowitz Medical/Optiskin
- Central Sooner Research
- Center for Clinical Studies, LTD.LLP
- Charité Centrum für Innere Medizin und Dermatologie, Institute of Allergology (IFA)
- Katholisches Klinikum Bochum gGmbH, Dermatologische Studienambulanz
- Universitatsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik fur Dermatologie
- Universitätsklinikum Frankfurt Klinik für Dermatologie, Venerologie und Allergologie Klinische Forschung
- Universitätsklinikum Erlangen Hautklinik
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz Hautklinik, Clinical Research Center
- Universitaetsklinikum Muenster (UKM) - Klinik für Hautkrankheiten
- MT Medic Specjalistyczna Praktyka Lekarska
- Centrum Medyczne Ginemedica
- IP Clinic Sp. z o.o.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
CDX-0159 1.5mg/kg
CDX-0159 3mg/kg
Placebo
Arm Description
CDX-0159 1.5mg/kg administered once
CDX-0159 3.0 mg/kg administered once
Normal saline administered once
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Pharmacokinetic evaluation
CDX-0159 serum concentrations will be measured at specified visits
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04944862
Brief Title
A Study of CDX-0159 in Patients With Prurigo Nodularis
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single Dose Study to Assess the Safety, Pharmacokinetics, and Clinical Effect of CDX-0159 in Patients With Prurigo Nodularis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celldex Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prurigo Nodularis
Keywords
CDX-0159, barzolvolimab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CDX-0159 1.5mg/kg
Arm Type
Experimental
Arm Description
CDX-0159 1.5mg/kg administered once
Arm Title
CDX-0159 3mg/kg
Arm Type
Experimental
Arm Description
CDX-0159 3.0 mg/kg administered once
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline administered once
Intervention Type
Biological
Intervention Name(s)
CDX-0159
Other Intervention Name(s)
barzolvolimab
Intervention Description
administered intravenously
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
administered intravenously
Primary Outcome Measure Information:
Title
Safety and tolerability as assessed by the incidence and severity of adverse events
Description
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)
Secondary Outcome Measure Information:
Title
Pharmacokinetic evaluation
Description
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)
Title
Clinical effect of CDX-0159 on pruritus
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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 Exclusion Criteria:
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.
Facility Information:
Facility Name
Desert Sky Dermatology
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
University of Miami, Dermatology Clinical Trials Unit
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Revival Research Institute, LLC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Markowitz Medical/Optiskin
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Center for Clinical Studies, LTD.LLP
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Charité Centrum für Innere Medizin und Dermatologie, Institute of Allergology (IFA)
City
Berlin
Country
Germany
Facility Name
Katholisches Klinikum Bochum gGmbH, Dermatologische Studienambulanz
City
Bochum
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik fur Dermatologie
City
Dresden
Country
Germany
Facility Name
Universitätsklinikum Frankfurt Klinik für Dermatologie, Venerologie und Allergologie Klinische Forschung
City
Frankfurt
Country
Germany
Facility Name
Universitätsklinikum Erlangen Hautklinik
City
Mainz
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Hautklinik, Clinical Research Center
City
Mainz
Country
Germany
Facility Name
Universitaetsklinikum Muenster (UKM) - Klinik für Hautkrankheiten
City
Münster
Country
Germany
Facility Name
MT Medic Specjalistyczna Praktyka Lekarska
City
Krosno
Country
Poland
Facility Name
Centrum Medyczne Ginemedica
City
Wrocław
Country
Poland
Facility Name
IP Clinic Sp. z o.o.
City
Łódź
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
A Study of CDX-0159 in Patients With Prurigo Nodularis
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