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New shot aims to stop the itch of prurigo nodularis

NCT ID NCT06366750

Symptom relief Sponsor: Celldex Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This phase 2 trial tests a drug called barzolvolimab in 140 adults with prurigo nodularis, a skin condition causing intense itching and hard bumps. Participants receive either the drug or a placebo as a shot under the skin. The main goal is to see if the drug reduces itch severity by at least 4 points on a 0-10 scale after 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
barzolvolimab (a biologic drug given as a shot under the skin)
What this could lead to
If it works, this could point toward a new treatment option for people with prurigo nodularis who suffer from severe itching.
What could go wrong
This is a mid-stage trial with only 140 people, so results may not apply to everyone. The drug may not reduce itch better than a placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

140 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Males and females, ≥18 years of age. 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 for stage of chronic nodular prurigo (IGA-CNPG-S) 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) once or twice a day 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 PN lesions limited to small area on one side of the body (e.g., only one arm affected). 3. Active unstable pruritic skin conditions in addition to PN. 4. Documented atopic dermatitis (moderate to severe) within 6 months before the start of screening. 5. Females who are pregnant or nursing. 6. Known hepatitis B or hepatitis C infection or active COVID-19 infection. 7. 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. 8. History of anaphylaxis. 9. Prior receipt of barzolvolimab There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

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Conditions

The condition(s) this trial relates to.

prurigo nodularis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prurigo nodularis

Contacts and locations

Locations

  • Advanced Clinical Research Institute

    Tampa, Florida, 33607, United States

  • Apex Clinical Research Center - Canton

    Canton, Ohio, 44718, United States

  • Biobrilliance Medical Research Center

    Hialeah, Florida, 33106, United States

  • Cahaba Dermatology Skin Health Center

    Birmingham, Alabama, 35244, United States

  • Center for Clinical Studies

    Webster, Texas, 77598, United States

  • Center for Dermatology Clinical Research, Inc

    Fremont, California, 94538, United States

  • Centricity Research

    Columbus, Georgia, 31904, United States

  • Centrum Medyczne Pratia Katowice

    Katowice, Poland

  • Centrum Nowoczesnych Terapii "Dobry Lekarz"

    Krakow, Małopolska, Poland

  • Clinical /research group Z.o.o.

    Warsaw, Poland

  • Columbia Dermatology and Aesthetics

    Columbia, South Carolina, 29212, United States

  • Complexo Hospitalario Universitario de Santiago de Compostela

    A Coruña, Spain

  • DERMACEUM Centrum Badan

    Wroclaw, Poland

  • DS Research of Kentucky, LLC

    Louisville, Kentucky, 40241, United States

  • DS Research of Southern Indiana, LLC

    Clarksville, Indiana, 47129, United States

  • Derm Effects

    London, Ontario, Canada

  • Dermatology Institute & Skin Care Center

    Santa Monica, California, 90404, United States

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75230, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Empire Clinical Research

    Pomona, California, 91767, United States

  • Encore Medical Research

    Hollywood, Florida, 33024, United States

  • Encore Medical Research Boynton Beach

    Boynton Beach, Florida, 33436, United States

  • Encore Medical Research of Weston

    Weston, Florida, 33331, United States

  • Equity Medical

    Bowling Green, Kentucky, 42104, United States

  • Equity Medical

    New York, New York, 10023, United States

  • Fachklinik Bad Bentheim, Klinisches Studienzentrum

    Bad Bentheim, Germany

  • Focus Clinical Research

    West Hills, California, 91307, United States

  • FutureMeds - Madrid

    Madrid, Spain

  • FutureMeds - Sevilla

    Seville, Spain

  • FutureMeds Gdynia

    Gdynia, Poland

  • Guelph Dermatology Research

    Guelph, Ontario, Canada

  • Gyncentrum sp. z o.o.

    Katowice, Poland

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

    Warsaw, Poland

  • Hospital General Universitario Dr Balmis, ISABIAL

    Alicante, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Institut für Allergieforschung (IFA),Charité - Universitätsmedizin Berlin

    Berlin, Germany

  • International Clinical Research - Tennessee LLC

    Murfreesboro, Tennessee, 37130, United States

  • Investigate MD, LLC

    Scottsdale, Arizona, 85255, United States

  • Katholisches Klinikum Bochum

    Bochum, Germany

  • Kingsway Clinical Research

    Etobicoke, Ontario, Canada

  • Klinika Ambroziak Dermatologia

    Warsaw, Poland

  • LUXDERM Specjalistyczny Gabinet

    Lublin, Poland

  • Life Arc Research Centers Corp

    Miami, Florida, 33126, United States

  • Medisearch, LLC

    Saint Joseph, Missouri, 64506, United States

  • MetroMed Clinical Trials

    Chicago, Illinois, 60614, United States

  • North York Research Inc

    Toronto, Ontario, Canada

  • Paddington Testing, PO

    Philadelphia, Pennsylvania, 01913, United States

  • Pratia MCM Krakόw

    Krakow, Poland

  • Profound Research LLC

    Oceanside, California, 92056, United States

  • Revival Research Institute, LLC

    Troy, Michigan, 48084, United States

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260, United States

  • SimcoDerm Medical and Surgical Dermatology Center

    Barrie, Ontario, Canada

  • Skin Specialists PC

    Omaha, Nebraska, 68144, United States

  • Solmed Clinic

    Zagreb, Croatia

  • Special Hospital Medico

    Rijeka, Croatia

  • Stratica Dermatology

    Edmonton, Alberta, Canada

  • Total Dermatology

    Birmingham, Alabama, 35203, United States

  • Treasure Valley Medical Research

    Boise, Idaho, 83706, United States

  • UC Health Physicians Office Dermatology

    Cincinnati, Ohio, 45219, United States

  • University Hospital Center - Rijeka

    Rijeka, Croatia

  • University Hospital Heidelberg

    Heidelberg, Germany

  • University of California San Francisco

    San Francisco, California, 94115, United States

  • University of California, San Francisco

    San Francisco, California, 94115, United States

  • University of Miami

    Miami, Florida, 33134, United States

  • University of New Mexico Department of Dermatology

    Albuquerque, New Mexico, 87102, United States

  • Universitätsklinikum Augsburg

    Augsburg, Germany

  • Universitätsklinikum Erlangen - Hautklinik

    Erlangen, Germany

  • Universitätsklinikum Münster (UKM)

    Münster, Germany

  • Universitätsklinikum RWTH Aachen- Dermatology

    Frankfurt, 52074, Germany

  • Universitätsklinikum Tübingen - Hautklinik

    Tübingen, Germany

  • Universtätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und

    Frankfurt, Germany

  • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

    Rzeszów, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.