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Evaluating barzolvolimab for treating prurigo nodularis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Patients With Prurigo Nodularis

Phase 2 Interventional Celldex Therapeutics · NCT06366750

This study is testing a new treatment called barzolvolimab to see if it can help adults with prurigo nodularis feel less itchy and improve their skin condition.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment120 (estimated)
Ages18 Years and up
SexAll
SponsorCelldex Therapeutics Industry-sponsored
Drugs / interventionsbarzolvolimab
Locations52 sites (Birmingham, Alabama and 51 other locations)
Trial IDNCT06366750 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of barzolvolimab (CDX-0159) in adults diagnosed with prurigo nodularis. Participants will undergo a screening period of approximately 28 days, followed by a 24-week double-blind treatment phase where they will receive either barzolvolimab or a placebo via subcutaneous injections. The study includes a follow-up period of 16 weeks after treatment to assess long-term effects. The primary focus is on patients with severe itch and significant nodular lesions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of prurigo nodularis and severe itch unresponsive to topical treatments.

Not a fit: Patients who do not have prurigo nodularis or those who have not experienced inadequate responses to topical medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce itch and improve the quality of life for patients suffering from prurigo nodularis.

How similar studies have performed: While this approach is being explored, similar studies have shown promise in treating chronic itch conditions, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prurigo NodularisbarzolvolimabPNCDX-0159
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.