Barzolvolimab for Eczema

Recruiting at 50 trial locations

Overseen By Celldex Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Celldex Therapeutics

Must not be taking: Anti-KIT therapy

Disqualifiers: Other pruritic skin diseases, phototherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 8

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the efficacy and safety of a drug called barzolvolimab for adults with atopic dermatitis, also known as eczema. The trial includes different groups, with some receiving varying doses of barzolvolimab and others starting with a placebo (a substance with no active drug) before switching to barzolvolimab. Participants must have had moderate to severe eczema for at least a year and continue to experience severe itching despite other topical treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in eczema treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that barzolvolimab is generally well-tolerated. In earlier studies, no side effect occurred in more than one person. Some participants noticed a slight darkening of their skin, which was minor and faded over time. Mild changes in hair color also occurred.

Overall, barzolvolimab has a good safety record, indicating it is safe for most people based on current data. While some side effects exist, they are uncommon and not serious for most individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Barzolvolimab is unique because it targets the body's immune response differently from typical eczema treatments like topical steroids and immunosuppressants. Most treatments for eczema aim to reduce inflammation and suppress the immune system broadly, but Barzolvolimab specifically targets and inhibits a protein called KIT, which plays a key role in the activation of mast cells involved in allergic reactions. This targeted approach could potentially offer more precise symptom control with fewer side effects. Additionally, Barzolvolimab is administered via subcutaneous injection on a monthly basis, which might provide a more convenient dosing schedule compared to daily treatments. Researchers are excited about its potential to offer a new, effective option for those who haven't found relief with current therapies.

What evidence suggests that barzolvolimab might be an effective treatment for eczema?

Studies have shown that barzolvolimab can effectively treat skin conditions like eczema. Research indicates that patients using barzolvolimab experienced quick and lasting improvements. Other studies demonstrated significant symptom relief, with a strong reduction in itchiness and hives. Patients often report a meaningful decrease in symptoms, suggesting the treatment works well for those with chronic skin issues. These findings highlight barzolvolimab's potential to help people with atopic dermatitis (eczema), offering a promising new option. Participants in this trial will receive different dosages of barzolvolimab or a placebo followed by barzolvolimab to further evaluate its effectiveness. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

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

I can fill out a daily symptom diary and follow the study schedule.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Barzolvolimab

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06727552?intr=barzolvolimab&rank=1

A Study of Barzolvolimab in Patients With Atopic Dermatitis This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of barzolvolimab ...

2. 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 ... “In this large Phase 2 study, patients on barzolvolimab experienced rapid, profound, durable complete response which correlated with meaningful ...

3. dermatologytimes.com dermatologytimes.com/view/efficacy-results-from-the-barzolvolimab-trial

Efficacy Results From the Barzolvolimab Trial An expert discusses how barzolvolimab demonstrated statistically significant and clinically meaningful reductions in UAS7 scores, with over 50% ...

4. ir.celldex.com ir.celldex.com/news-releases/news-release-details/celldex-presents-data-demonstrating-barzolvolimab-improves

Release Details Key data highlights: Barzolvolimab demonstrated rapid and sustained efficacy in patients with CSU with both low (<40) and normal/high (>40) IgE ...

5. jacionline.org jacionline.org/article/S0091-6749(24)01475-1/pdf

181 Systemic Treatments For Severe Eczema The results of this study highlight a need for clearer data on rates of adverse effects when these medications are used specifically for atopic dermatitis. 182 ...

6. ir.celldex.com ir.celldex.com/news-releases/news-release-details/celldex-initiates-phase-2-study-barzolvolimab-atopic-dermatitis

Celldex Initiates Phase 2 Study of Barzolvolimab in Atopic ... The randomized, double-blind, placebo-controlled Phase 2 study is evaluating the efficacy and safety profile of subcutaneous barzolvolimab in patients with ...

7. dermatologytimes.com dermatologytimes.com/view/safety-results-from-the-barzolvolimab-trial

Safety Results From the Barzolvolimab Trial Additional safety signals included skin hyperpigmentation (1% at 16 weeks, 13% at 52 weeks), which appeared minimal and less pronounced than ...

8. ir.celldex.com ir.celldex.com/news-releases/news-release-details/celldex-presents-additional-positive-data-demonstrating

Release Details Barzolvolimab demonstrated a well tolerated safety profile throughout the study and KIT related tolerability events, mild hair color changes and ...

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

51372 Barzolvolimab demonstrates safety and clinically ... Barzolvolimab was generally well tolerated. No adverse event was reported in more than one barzolvolimab treated patient. One patient (3.0 mg/kg) had ...