A Study of CDX-0159 in Patients With Prurigo Nodularis

NCT04944862 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CDX0159-04
• Study Type: interventional
• Target: 24
• Locations: 3 countries
• Sites: 17

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.

Conditions

Prurigo Nodularis

Keywords

CDX-0159; barzolvolimab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pharmacokinetic evaluation

  From Day 1 (before first dose) to Day 169 (last follow-up visit)

• Clinical effect of CDX-0159 on pruritus

  From Day 1 (first dose) to Day 57 (week 8)

Study Arms (3)

CDX-0159 1.5mg/kg

EXPERIMENTAL

CDX-0159 1.5mg/kg administered once

Biological: CDX-0159

CDX-0159 3mg/kg

EXPERIMENTAL

CDX-0159 3.0 mg/kg administered once

Biological: CDX-0159

Placebo

PLACEBO COMPARATOR

Normal saline administered once

Drug: Normal saline

Interventions

CDX-0159 BIOLOGICAL

administered intravenously

Also known as: barzolvolimab

CDX-0159 1.5mg/kg; CDX-0159 3mg/kg

Normal saline DRUG

administered intravenously

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (17)

Desert Sky Dermatology

Tempe, Arizona, 85284, United States

Location

University of Miami, Dermatology Clinical Trials Unit

Miami, Florida, 33125, United States

Location

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Markowitz Medical/Optiskin

New York, New York, 10128, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Center for Clinical Studies, LTD.LLP

Houston, Texas, 77004, United States

Location

Charité Centrum für Innere Medizin und Dermatologie, Institute of Allergology (IFA)

Berlin, Germany

Location

Katholisches Klinikum Bochum gGmbH, Dermatologische Studienambulanz

Bochum, Germany

Location

Universitatsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik fur Dermatologie

Dresden, Germany

Location

Universitätsklinikum Frankfurt Klinik für Dermatologie, Venerologie und Allergologie Klinische Forschung

Frankfurt, Germany

Location

Universitätsklinikum Erlangen Hautklinik

Mainz, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz Hautklinik, Clinical Research Center

Mainz, Germany

Location

Universitaetsklinikum Muenster (UKM) - Klinik für Hautkrankheiten

Münster, Germany

Location

MT Medic Specjalistyczna Praktyka Lekarska

Krosno, Poland

Location

IP Clinic Sp. z o.o.

Lodz, Poland

Location

Centrum Medyczne Ginemedica

Wroclaw, Poland

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 30, 2021
• Study Start: November 8, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

PL (3); US (7); DE (7)