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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04944862
Other study ID # CDX0159-04
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 8, 2021
Est. completion date July 31, 2023

Study information

Verified date August 2023
Source Celldex Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 24
Est. completion date July 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Key Inclusion Criteria: 1. Males and females, 18 - 75 years old. 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. Key Exclusion Criteria: 1. PN due to neuropathy, psychiatric disorders or medications. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
CDX-0159
administered intravenously
Drug:
Normal saline
administered intravenously

Locations

Country Name City State
Germany 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
Poland MT Medic Specjalistyczna Praktyka Lekarska Krosno
Poland IP Clinic Sp. z o.o. Lódz
Poland Centrum Medyczne Ginemedica Wroclaw
United States University of New Mexico Albuquerque New Mexico
United States Center for Clinical Studies, LTD.LLP Houston Texas
United States University of Miami, Dermatology Clinical Trials Unit Miami Florida
United States Markowitz Medical/Optiskin New York New York
United States Central Sooner Research Norman Oklahoma
United States Desert Sky Dermatology Tempe Arizona
United States Revival Research Institute, LLC Troy Michigan

Sponsors (1)

Lead Sponsor Collaborator
Celldex Therapeutics

Countries where clinical trial is conducted

United States,  Germany,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 From Day 1 (first dose) to Day 169 (last follow-up visit)
Secondary Pharmacokinetic evaluation CDX-0159 serum concentrations will be measured at specified visits From Day 1 (before first dose) to Day 169 (last follow-up visit)
Secondary 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. From Day 1 (first dose) to Day 57 (week 8)
See also
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Completed NCT05052983 - A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis Phase 3
Active, not recruiting NCT04204616 - A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) Phase 3
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