Barzolvolimab for Prurigo Nodularis

Recruiting at 82 trial locations

Overseen By Celldex Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Celldex Therapeutics

Disqualifiers: Neuropathy, Psychiatric disorders, Atopic dermatitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new treatment, barzolvolimab (an anti-KIT monoclonal antibody), for individuals with prurigo nodularis, a skin condition that causes itchy, hard bumps. The study compares different doses of the medication to determine which is most effective and safe. Participants must have had prurigo nodularis for at least three months, with severe itching and at least 20 nodules across the body. The trial requires participants to use a moisturizer daily and track their symptoms in an electronic diary. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in managing prurigo nodularis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study doctor to understand how your current medications might interact with the trial requirements.

Is there any evidence suggesting that barzolvolimab is likely to be safe for humans?

Research shows that barzolvolimab is generally safe. Studies have found that patients receiving a single dose for prurigo nodularis (a skin condition causing itchy, hard lumps) experienced significant improvements in itching and skin healing. Reports from these studies indicate mostly mild side effects, suggesting the treatment's safety.

Barzolvolimab remains under investigation in ongoing trials, with researchers continuing to gather data on its long-term safety. Current evidence suggests it is a promising option with manageable side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prurigo nodularis?

Barzolvolimab is unique because it works by targeting the immune system in a different way than current treatments for prurigo nodularis, which often include topical steroids or immunosuppressants. It specifically targets the pathways involved in inflammation and itching, offering a new approach to managing the condition. Researchers are excited about Barzolvolimab because it has the potential to offer relief with a convenient subcutaneous administration every four weeks, which could be more manageable for patients compared to daily treatments.

What evidence suggests that barzolvolimab could be an effective treatment for prurigo nodularis?

Research has shown that barzolvolimab may help treat prurigo nodularis, a skin condition that causes itchy bumps. Early results suggest this treatment works by reducing mast cells, which play a key role in causing itchiness and inflammation. In one study, patients experienced significantly less itching and improved quality of life over 76 weeks. Another study demonstrated positive effects in reducing symptoms after just one dose. This trial will evaluate different dosing regimens of barzolvolimab, including 450 mg followed by either 300 mg or 150 mg every four weeks, as well as a placebo group. This evidence supports the potential of barzolvolimab for people dealing with prurigo nodularis. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This clinical trial is for adults with prurigo nodularis, a skin condition characterized by itchy lumps. Participants should meet specific health criteria set by the study's guidelines.

Inclusion Criteria

I am willing to apply a moisturizer daily during the study.

I agree to use effective birth control during and for 5 months after the study.

I have had severe itching, scoring 7 or more, in the past week.

Exclusion Criteria

I have nerve pain due to neuropathy, mental health issues, or medications.

I have been diagnosed with moderate to severe atopic dermatitis in the last 6 months.

History of anaphylaxis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive barzolvolimab or placebo by subcutaneous injections every 4 weeks for 24 weeks

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Barzolvolimab

Trial Overview The trial is testing barzolvolimab against a placebo to see if it can effectively and safely treat prurigo nodularis. Patients will be randomly assigned to receive either the actual drug or a placebo.

How Is the Trial Designed?

Group I: Barzolvolimab 450 mg, then 300 mg Q4W Experimental Treatment 1 Intervention

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.

Group II: Barzolvolimab 450 mg, then 150 mg Q4W Experimental Treatment 1 Intervention

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.

Group III: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Celldex Therapeutics

Lead Sponsor

Trials

66

Recruited

5,900+

Anthony S. Marucci

Celldex Therapeutics

Chief Executive Officer since 2008

MBA from Columbia University, MHL from Brown University

Diane C. Young

Celldex Therapeutics

Chief Medical Officer since 2019

MD from Harvard Medical School, AB in Biochemical Sciences from Harvard University

Published Research Related to This Trial

In a 12-week phase 2 trial involving 70 patients with moderate-to-severe prurigo nodularis, nemolizumab significantly reduced pruritus by 53% compared to a 20% reduction in the placebo group, demonstrating its efficacy in alleviating severe itching.

While nemolizumab showed promising results in reducing symptoms, it was associated with gastrointestinal and musculoskeletal side effects, indicating the need for further studies to assess its long-term safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis. Ständer, S., Yosipovitch, G., Legat, FJ., et al.[2020]

Dupilumab, an antibody that targets interleukin-4 and interleukin-13 pathways, showed good to excellent responses in three patients with severe prurigo nodularis after being treated off-label, indicating its potential efficacy for this condition.

The treatment was generally well-tolerated, with only one patient experiencing dry eyes, suggesting a favorable safety profile; however, further research with larger controlled trials is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab for prurigo nodularis: Case series and review of the literature. Holm, JG., Agner, T., Sand, C., et al.[2021]

In a phase 3 trial involving 274 adults with moderate-to-severe prurigo nodularis, nemolizumab significantly reduced itch and improved skin condition compared to placebo, with 56.3% of patients experiencing a notable reduction in itch versus 20.9% in the placebo group.

Nemolizumab also led to significant improvements in sleep quality and overall skin assessment, with common side effects being mild, such as headaches and atopic dermatitis, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. Kwatra, SG., Yosipovitch, G., Legat, FJ., et al.[2023]

Nemolizumab, a monoclonal antibody targeting interleukin 31 receptor α, shows promise as a treatment for moderate to severe prurigo nodularis (PN), significantly reducing itch and skin lesions in patients who experienced a notable decrease in pruritus after treatment.

In a study of 38 patients, nemolizumab treatment was associated with downregulation of inflammatory and neural signaling pathways, as well as changes in tissue remodeling and epidermal differentiation, indicating its potential mechanism of action in alleviating symptoms of PN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of Neuroimmune and Epithelial Dysregulation in Patients With Moderate to Severe Prurigo Nodularis Treated With Nemolizumab. Deng, J., Liao, V., Parthasarathy, V., et al.[2023]

In a phase 2a trial involving 50 patients with prurigo nodularis, vixarelimab significantly reduced itch severity by 50.6% compared to 29.4% in the placebo group after 8 weeks, indicating its efficacy in managing this chronic skin condition.

Vixarelimab also led to clearer skin in 30.4% of patients, with no serious adverse events reported, suggesting it is a safe and effective treatment option for reducing both pruritus and skin nodules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of vixarelimab, a human monoclonal oncostatin M receptor β antibody, in moderate-to-severe prurigo nodularis: a randomised, double-blind, placebo-controlled, phase 2a study. Sofen, H., Bissonnette, R., Yosipovitch, G., et al.[2023]

In a phase 2 trial involving 70 patients with moderate-to-severe prurigo nodularis, nemolizumab significantly reduced itch within 48 hours compared to placebo, demonstrating a 19.5% reduction in peak pruritus.

Patients treated with nemolizumab also experienced significant improvements in sleep disturbances by Day 4, with a 24.0% reduction in sleep disturbance scores, indicating its potential to enhance quality of life for those suffering from this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nemolizumab efficacy in prurigo nodularis: onset of action on itch and sleep disturbances. Ständer, S., Yosipovitch, G., Lacour, JP., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40840687/

A randomized phase 1b intravenous single-dose study Safety and efficacy of barzolvolimab, an anti-KIT monoclonal antibody, in adults with moderate-to-severe prurigo nodularis: A randomized phase ...

2. ir.celldex.com ir.celldex.com/news-releases/news-release-details/celldex-therapeutics-presents-positive-data-prurigo-nodularis

Celldex Therapeutics Presents Positive Data from Prurigo ... This study is the first to demonstrate that barzolvolimab, a mast cell depleting agent, can potentially be used to treat PN and other chronic itch indications.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06366750?intr=CDX-0159&rank=9

A Study of Barzolvolimab in Patients With Prurigo Nodularis The purpose of this study is to assess the efficacy and safety of barzolvolimab (CDX-0159) in adults with prurigo nodularis. There is a screening period of ...

4. ir.celldex.com ir.celldex.com/news-releases/news-release-details/celldex-presents-unprecedented-76-week-results-barzolvolimab

Celldex Presents Unprecedented 76 Week Results from ... Celldex (NASDAQ:CLDX) announced today new data demonstrating profound, sustained complete response and improved quality of life at 76 weeks.

5. biomedres.us biomedres.us/fulltexts/BJSTR.MS.ID.009685.php

Monoclonal Antibodies for Prurigo Nodularis This analysis examines dupilumab, nemolizumab, vixarelimab, and CDX-0159 (barzolvolimab) through information sourced from PubMed, Embase, Web of Science, and ...

6. celldex.com celldex.com/wp-content/uploads/2025/06/Barzolvolimab-Demonstrates-Safety-and-Clinically-Meaningful-Activity-in-Moderate-Severe-Prurigo-Nodularis_WCI2024.pdf

Barzolvolimab-Demonstrates-Safety-and-Clinically- ... • Barzolvolimab (CDX-0159), an anti-KIT monoclonal antibody, was well-tolerated, and demonstrated improvement in itch and urticarial lesions accompanied by ...

7. jaad.org jaad.org/article/S0190-9622(24)01603-7/fulltext

51372 Barzolvolimab demonstrates safety and clinically ... Conclusion: A single dose of barzolvolimab was generally well tolerated and accompanied by clinically meaningful improvements in itch and PN lesion healing ...