Barzolvolimab for Eczema

Recruiting at 16 trial locations

Overseen By Celldex Therapeutics

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Celldex Therapeutics

Must not be taking: Anti-KIT therapy

Disqualifiers: Other pruritic skin diseases, phototherapy, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with Atopic Dermatitis

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that the use of certain prohibited medications is not allowed during the study. It's best to discuss your current medications with the study doctor to see if they are allowed.

What data supports the effectiveness of the drug Barzolvolimab for eczema?

There is no direct data on Barzolvolimab for eczema, but similar treatments like dupilumab have shown effectiveness in improving eczema symptoms in clinical trials. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with moderate to severe Atopic Dermatitis, characterized by a certain severity score (EASI ≥ 16), at least 10% of body surface affected, and intense itchiness. Participants must have tried topical medications without success or cannot use them for medical reasons. They should be willing to keep a daily symptom diary.

Inclusion Criteria

I have been diagnosed with chronic atopic dermatitis for over a year.

I am 18 years old or older.

Topical treatments have not worked for me or are not suitable due to my health.

Exclusion Criteria

I have not had UV light treatment in the last 4 weeks.

I will not use any medications not allowed in the study.

I have never received barzolvolimab or other anti-KIT therapy.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Double-blind, placebo-controlled treatment

Participants receive either barzolvolimab or placebo by subcutaneous injections every 4 weeks

16 weeks

4 visits (in-person)

Double-blind, active treatment

Participants receive barzolvolimab by subcutaneous injections every 4 weeks

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Treatment Details

Interventions

• Barzolvolimab (Monoclonal Antibodies)

Trial Overview The study tests the effectiveness and safety of Barzolvolimab compared to a placebo in treating Atopic Dermatitis. Patients will randomly receive either the actual drug or an inactive substance to see if there's an improvement in their skin condition.

Participant Groups

Group I: Placebo then barzolvolimab 300 mg Experimental Treatment 2 Interventions

Placebo subcutaneous injection every 4 weeks for 16 weeks and then barzolvolimab loading dose of 450 mg followed by 300 mg administered every 4 weeks for 16 weeks.

Group II: Placebo then barzolvolimab 150 mg Experimental Treatment 2 Interventions

Placebo subcutaneous injection every 4 weeks for 16 weeks and then barzolvolimab loading dose of 450 mg followed by 150 mg administered every 4 weeks for 16 weeks.

Group III: Barzolvolimab 300 mg Experimental Treatment 1 Intervention

Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 300 mg administered every 4 weeks for 32 weeks

Group IV: Barzolvolimab 150 mg Experimental Treatment 1 Intervention

Barzolvolimab loading dose of 450 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 32 weeks

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

The Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT) is a significant study involving 62 children aged 4 to 19 with severe eczema, aiming to evaluate the efficacy of the anti-IgE treatment omalizumab over a 6-month period compared to a placebo.

The study is designed to detect a 33% relative reduction in eczema severity, measured by the SCORAD score, which could provide important insights into the role of IgE in childhood eczema and the potential of omalizumab as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT): the role of anti-IgE in severe paediatric eczema: study protocol for a randomised controlled trial. Chan, S., Cornelius, V., Chen, T., et al.[2021]

In a network meta-analysis of 19 randomized controlled trials involving systemic therapies for moderate-to-severe atopic dermatitis, upadacitinib 30 mg once daily showed the highest efficacy, with 83.6% of patients achieving a significant improvement in eczema severity (EASI-50 response).

Abrocitinib and dupilumab also demonstrated strong efficacy, particularly in combination therapy, but all active treatments had a higher incidence of treatment-emergent adverse events compared to placebo, with no significant differences in safety among the active treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of systemic therapies used in moderate-to-severe atopic dermatitis: a systematic literature review and network meta-analysis. Silverberg, JI., Thyssen, JP., Fahrbach, K., et al.[2021]

The TREAT Registry Taskforce developed a standardized core set of 19 domains and 69 items for measuring outcomes in atopic eczema (AE) research, based on input from 479 participants across 36 countries.

This standardized approach will enhance the comparability of data across different registries, ultimately improving the understanding of the effectiveness, safety, and cost-effectiveness of immunomodulatory therapies for AE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TREatment of ATopic eczema (TREAT) Registry Taskforce: an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema photo- and systemic therapy registries. Gerbens, LAA., Apfelbacher, CJ., Irvine, AD., et al.[2020]

Efalizumab shows potential as a treatment for severe recalcitrant atopic eczema, although its specific therapeutic efficacy and effects on the immune response are still not fully understood.

The study aims to provide insights into clinical outcomes and the nature of inflammatory cells involved during efalizumab treatment, addressing a significant challenge in managing widespread moderate to severe atopic eczema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and immunopathologic findings during treatment of recalcitrant atopic eczema with efalizumab. Hassan, AS., Kaelin, U., Braathen, LR., et al.[2019]

In a 24-week study involving 226 adults with moderate-to-severe atopic dermatitis, nemolizumab (30 mg) significantly improved skin inflammation and itching compared to placebo, showing effects as early as week 4.

The treatment was found to be safe and well-tolerated, with common side effects including nasopharyngitis and upper respiratory infections, indicating a favorable safety profile for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. Silverberg, JI., Pinter, A., Pulka, G., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT): the role of anti-IgE in severe paediatric eczema: study protocol for a randomised controlled trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of systemic therapies used in moderate-to-severe atopic dermatitis: a systematic literature review and network meta-analysis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

TREatment of ATopic eczema (TREAT) Registry Taskforce: an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema photo- and systemic therapy registries. [2020]

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

Clinical and immunopathologic findings during treatment of recalcitrant atopic eczema with efalizumab. [2019]

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

Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. [2020]