A Study of Barzolvolimab in Patients With Prurigo Nodularis

NCT06366750 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: CDX0159-102023-510279-80-00
• Study Type: interventional
• Target: 140
• Locations: 6 countries
• Sites: 72

Brief Summary

The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis.

Conditions

Prurigo Nodularis

Keywords

barzolvolimab; PN; CDX-0159

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12.

  WI-NRS is a validated measure of itch severity. Participants are asked daily to rate the intensity of their worst pruritis (itch) over the past 24 hours using an 11-point scale ranging from 0= no itch to 10= worst imaginable itch. Higher scores indicate more severity.

  From Day 1 (first dose) to Day 85 (week 12)

Secondary Outcomes (24)

• Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 4.

  From Day 1 (first dose) to Week 4

• Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 24.

  From Day 1 (first dose) to Week 24

• Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Day 169 (week 24).

  From Day 1 (first dose) to Day 169 (week 24)

• Proportion of participants with Investigator Global Assessment for stage of chronic nodular prurigo score (IGA-CNPG-S) of 0 or 1 at Weeks 4, 12 and 24.

  From Day 1 (first dose) to Day 169 (week 24)

• Proportion of participants with improvement in both WI-NRS by ≥ 4 from baseline and IGA-CNPG-S score of 0 or 1 at Weeks 4, 12 and 24.

  From Day 1 (first dose) to Day 169 (week 24)

Study Arms (3)

Barzolvolimab 450 mg, then 150 mg Q4W

EXPERIMENTAL

450 mg subcutaneous administration loading dose on Day 1 followed by 150 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.

Biological: barzolvolimab

Barzolvolimab 450 mg, then 300 mg Q4W

EXPERIMENTAL

450 mg subcutaneous administration loading dose on Day 1 followed by 300 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.

Biological: barzolvolimab

Placebo

PLACEBO COMPARATOR

Matching placebo subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.

Other: Matching Placebo

Interventions

Matching Placebo OTHER

subcutaneous administration

Placebo

barzolvolimab BIOLOGICAL

subcutaneous administration

Barzolvolimab 450 mg, then 150 mg Q4W; Barzolvolimab 450 mg, then 300 mg Q4W

Eligibility Criteria

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

You may qualify if:

• Males and females, ≥18 years of age.
• 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 for stage of chronic nodular prurigo (IGA-CNPG-S) 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) once or twice a day 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 PN lesions limited to small area on one side of the body (e.g., only one arm affected).
• Active unstable pruritic skin conditions in addition to PN.
• Documented atopic dermatitis (moderate to severe) within 6 months before the start of screening.
• Females 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.
• Prior receipt of barzolvolimab
• 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 (72)

Total Dermatology

Birmingham, Alabama, 35203, United States

Location

Cahaba Dermatology Skin Health Center

Birmingham, Alabama, 35244, United States

Location

Investigate MD, LLC

Scottsdale, Arizona, 85255, United States

Location

Scottsdale Clinical Trials

Scottsdale, Arizona, 85260, United States

Location

Center for Dermatology Clinical Research, Inc

Fremont, California, 94538, United States

Location

Profound Research LLC

Oceanside, California, 92056, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

University of California San Francisco

San Francisco, California, 94115, United States

Location

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Dermatology Institute & Skin Care Center

Santa Monica, California, 90404, United States

Location

Focus Clinical Research

West Hills, California, 91307, United States

Location

Encore Medical Research Boynton Beach

Boynton Beach, Florida, 33436, United States

Location

Biobrilliance Medical Research Center

Hialeah, Florida, 33106, United States

Location

Encore Medical Research

Hollywood, Florida, 33024, United States

Location

Life Arc Research Centers Corp

Miami, Florida, 33126, United States

Location

University of Miami

Miami, Florida, 33134, United States

Location

Advanced Clinical Research Institute

Tampa, Florida, 33607, United States

Location

Encore Medical Research of Weston

Weston, Florida, 33331, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Centricity Research

Columbus, Georgia, 31904, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

MetroMed Clinical Trials

Chicago, Illinois, 60614, United States

Location

DS Research of Southern Indiana, LLC

Clarksville, Indiana, 47129, United States

Location

Equity Medical

Bowling Green, Kentucky, 42104, United States

Location

DS Research of Kentucky, LLC

Louisville, Kentucky, 40241, United States

Location

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

Location

Medisearch, LLC

Saint Joseph, Missouri, 64506, United States

Location

Skin Specialists PC

Omaha, Nebraska, 68144, United States

Location

University of New Mexico Department of Dermatology

Albuquerque, New Mexico, 87102, United States

Location

Equity Medical

New York, New York, 10023, United States

Location

Apex Clinical Research Center - Canton

Canton, Ohio, 44718, United States

Location

UC Health Physicians Office Dermatology

Cincinnati, Ohio, 45219, United States

Location

Paddington Testing, PO

Philadelphia, Pennsylvania, 01913, United States

Location

Columbia Dermatology and Aesthetics

Columbia, South Carolina, 29212, United States

Location

International Clinical Research - Tennessee LLC

Murfreesboro, Tennessee, 37130, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

Stratica Dermatology

Edmonton, Alberta, Canada

Location

SimcoDerm Medical and Surgical Dermatology Center

Barrie, Ontario, Canada

Location

Kingsway Clinical Research

Etobicoke, Ontario, Canada

Location

Guelph Dermatology Research

Guelph, Ontario, Canada

Location

Derm Effects

London, Ontario, Canada

Location

North York Research Inc

Toronto, Ontario, Canada

Location

Special Hospital Medico

Rijeka, Croatia

Location

University Hospital Center - Rijeka

Rijeka, Croatia

Location

Solmed Clinic

Zagreb, Croatia

Location

Universitätsklinikum Augsburg

Augsburg, Germany

Location

Fachklinik Bad Bentheim, Klinisches Studienzentrum

Bad Bentheim, Germany

Location

Institut für Allergieforschung (IFA),Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Katholisches Klinikum Bochum

Bochum, Germany

Location

Universitätsklinikum Erlangen - Hautklinik

Erlangen, Germany

Location

Universitätsklinikum RWTH Aachen- Dermatology

Frankfurt, 52074, Germany

Location

Universtätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und

Frankfurt, Germany

Location

University Hospital Heidelberg

Heidelberg, Germany

Location

Universitätsklinikum Münster (UKM)

Münster, Germany

Location

Universitätsklinikum Tübingen - Hautklinik

Tübingen, Germany

Location

Centrum Nowoczesnych Terapii "Dobry Lekarz"

Krakow, Małopolska, Poland

Location

FutureMeds Gdynia

Gdynia, Poland

Location

Centrum Medyczne Pratia Katowice

Katowice, Poland

Location

Gyncentrum sp. z o.o.

Katowice, Poland

Location

Pratia MCM Krakόw

Krakow, Poland

Location

LUXDERM Specjalistyczny Gabinet

Lublin, Poland

Location

Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

Rzeszów, Poland

Location

Clinical /research group Z.o.o.

Warsaw, Poland

Location

Gyncentrum sp. z o.o., NZOZ Gyncentrum - Oddział Warszawa

Warsaw, Poland

Location

Klinika Ambroziak Dermatologia

Warsaw, Poland

Location

DERMACEUM Centrum Badan

Wroclaw, Poland

Location

Complexo Hospitalario Universitario de Santiago de Compostela

A Coruña, Spain

Location

Hospital General Universitario Dr Balmis, ISABIAL

Alicante, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

FutureMeds - Madrid

Madrid, Spain

Location

FutureMeds - Sevilla

Seville, Spain

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 16, 2024
• Study Start: April 12, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

PL (11); CA (6); US (37); ES (5); DE (10); CR (3)