Barzolvolimab for Prurigo Nodularis

Recruiting at 51 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

Trial Summary

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.

What data supports the effectiveness of the drug Barzolvolimab for treating prurigo nodularis?

While there is no direct data on Barzolvolimab for prurigo nodularis, similar treatments like nemolizumab and dupilumab, which target related pathways, have shown positive results in reducing itch and improving symptoms in prurigo nodularis patients. ^{1 2 3 4 5}

How is the drug Barzolvolimab different from other drugs for prurigo nodularis?

Barzolvolimab is unique because it targets the KIT receptor, which is different from other treatments like vixarelimab and nemolizumab that focus on cytokine pathways such as interleukin-31. This novel approach may offer a new way to manage prurigo nodularis by addressing different underlying mechanisms of the disease. ^{1 2 3 5 6}

What is the purpose of this trial?

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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 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]

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]

References

1. England 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Dupilumab for prurigo nodularis: Case series and review of the literature. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Nemolizumab efficacy in prurigo nodularis: onset of action on itch and sleep disturbances. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Modulation of Neuroimmune and Epithelial Dysregulation in Patients With Moderate to Severe Prurigo Nodularis Treated With Nemolizumab. [2023]