A Study of CDX-0159 in Patients With Prurigo Nodularis

Prurigo Nodularis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04944862
• Other study ID #: CDX0159-04
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Neurodermatitis
• Prurigo
• Prurigo Nodularis

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)