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A Study of CDX-0159 in Patients With Prurigo Nodularis

Sponsor
Celldex Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04944862
Collaborator
(none)
30
Enrollment
11
Locations
3
Arms
12.7
Anticipated Duration (Months)
2.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CDX-0159
  • Drug: Normal saline
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 8, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability as assessed by the incidence and severity of adverse events [From Day 1 (first dose) to Day 169 (last follow-up visit)]

      Safety and tolerability of multiple dose levels of CDX-0159 as determined by drug related adverse events

    Secondary Outcome Measures

    1. Pharmacokinetic evaluation [From Day 1 (before first dose) to Day 169 (last follow-up visit)]

      CDX-0159 serum concentrations will be measured at specified visits

    2. Clinical effect of CDX-0159 on pruritus [From Day 1 (first dose) to Day 57 (week 8)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    3. At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.

    4. An Investigators Global Assessment (IGA) score for PN ≥ 3 at screening and Baseline (Day 1).

    5. 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.

    6. Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.

    7. Willing to apply a topical moisturizer (emollient) twice daily throughout the study.

    8. 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.

    9. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Desert Sky Dermatology Gilbert Arizona United States 85295
    2 University of Miami, Dermatology Clinical Trials Unit Miami Florida United States 33125
    3 Olympian Clinical Research Tampa Florida United States 33614
    4 Skin Sciences, PLLC Louisville Kentucky United States 40217
    5 Revival Research Institute, LLC Troy Michigan United States 48084
    6 University of New Mexico Albuquerque New Mexico United States 87131
    7 Markowitz Medical/Optiskin New York New York United States 10128
    8 Central Sooner Research Norman Oklahoma United States 73071
    9 Center for Clinical Studies, LTD.LLP Houston Texas United States 77004
    10 Charité Centrum für Innere Medizin und Dermatologie, Institute of Allergology (IFA) Berlin Germany
    11 Universitätsklinikum Frankfurt Klinik für Dermatologie, Venerologie und Allergologie Klinische Forschung Frankfurt Germany

    Sponsors and Collaborators

    • Celldex Therapeutics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Celldex Therapeutics
    ClinicalTrials.gov Identifier:
    NCT04944862
    Other Study ID Numbers:
    • CDX0159-04
    First Posted:
    Jun 30, 2021
    Last Update Posted:
    May 6, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Celldex Therapeutics
    CDX-0159
    barzolvolimab
    Additional relevant MeSH terms:
    Prurigo
    Neurodermatitis

    Study Results

    No Results Posted as of May 6, 2022