A Study of CDX-0159 in Patients With Prurigo Nodularis

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

The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis.

Study Overview

• Status: Completed
• Conditions: Prurigo Nodularis
• Intervention / Treatment: Biological: CDX-0159; Drug: Normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charité Centrum für Innere Medizin und Dermatologie, Institute of Allergology (IFA)
  • Bochum, Germany
    • Katholisches Klinikum Bochum gGmbH, Dermatologische Studienambulanz
  • Dresden, Germany
    • Universitatsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik fur Dermatologie
  • Frankfurt, Germany
    • Universitätsklinikum Frankfurt Klinik für Dermatologie, Venerologie und Allergologie Klinische Forschung
  • Mainz, Germany
    • Universitätsklinikum Erlangen Hautklinik
  • Mainz, Germany
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz Hautklinik, Clinical Research Center
  • Münster, Germany
    • Universitaetsklinikum Muenster (UKM) - Klinik für Hautkrankheiten
• Poland
  • Krosno, Poland
    • MT Medic Specjalistyczna Praktyka Lekarska
  • Wrocław, Poland
    • Centrum Medyczne Ginemedica
  • Łódź, Poland
    • IP Clinic Sp. z o.o.
• United States
  • Arizona
    • Tempe, Arizona, United States, 85284
      • Desert Sky Dermatology
  • Florida
    • Miami, Florida, United States, 33125
      • University of Miami, Dermatology Clinical Trials Unit
  • Michigan
    • Troy, Michigan, United States, 48084
      • Revival Research Institute, LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico
  • New York
    • New York, New York, United States, 10128
      • Markowitz Medical/Optiskin
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
  • Texas
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies, LTD.LLP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CDX-0159 1.5mg/kg; CDX-0159 1.5mg/kg administered once	Biological: CDX-0159; administered intravenously; Other Names: barzolvolimab
Experimental: CDX-0159 3mg/kg; CDX-0159 3.0 mg/kg administered once	Biological: CDX-0159; administered intravenously; Other Names: barzolvolimab
Placebo Comparator: Placebo; Normal saline administered once	Drug: Normal saline; administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Celldex Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: CDX-0159; barzolvolimab
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Prurigo; Neurodermatitis
• Other Study ID Numbers: CDX0159-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No