Dupilumab for Allergic Contact Dermatitis

Overseen By Liset Chacin, BA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Brigham and Women's Hospital

Must not be taking: Systemic immunosuppressants, Biologics

Disqualifiers: Psoriasis, HIV, Hepatitis, Malignancy, 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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of dupilumab for individuals with allergic contact dermatitis, a skin condition that flares up upon exposure to certain allergens. The study tests the effects of dupilumab, administered by injection, on skin reactions and overall symptoms. Individuals with persistent allergic contact dermatitis who have not improved with topical treatments and allergen avoidance may be suitable candidates. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before joining. You cannot have used systemic immune-regulating medications like azathioprine or methotrexate within 3 months, or biologic agents like TNF inhibitors within 4 months before the trial starts. Additionally, you must not have used cyclosporine or prednisone within 1 month, or topical corticosteroids within 1 week before the trial.

What is the safety track record for dupilumab?

Research has shown that dupilumab has been thoroughly studied for safety, with most patients tolerating it well. One study examined dupilumab in combination with skin creams and found it safe for individuals with moderate to severe skin issues. Another study confirmed its safety when used alone, without additional treatments. Some patients might experience mild side effects, such as redness at the injection site or slight eye irritation, but these are usually not serious.

Dupilumab is already approved by the FDA for other conditions, indicating a strong safety record. Overall, the evidence supports dupilumab as a safe option for many patients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dupilumab is unique because it targets interleukin-4 and interleukin-13 signaling pathways, which play a crucial role in the immune response that leads to allergic contact dermatitis. Unlike traditional treatments like corticosteroids, which broadly suppress inflammation, Dupilumab specifically blocks these pathways, potentially reducing side effects and offering a more targeted approach. Researchers are excited about this treatment because it promises a more precise mechanism of action, which could result in better long-term control of symptoms for patients suffering from this irritating skin condition.

What is the effectiveness track record for dupilumab in treating allergic contact dermatitis?

Research has shown that dupilumab effectively treats skin conditions like atopic dermatitis. Studies have found that it greatly improves symptoms in people with moderate-to-severe atopic dermatitis. Dupilumab blocks certain proteins in the body that cause inflammation. Although allergic contact dermatitis differs from atopic dermatitis, dupilumab has shown promise in treating various skin conditions, including allergic contact dermatitis. Many patients experience better skin and less itchiness with dupilumab. This treatment is already approved for other skin issues, which supports its potential effectiveness for allergic contact dermatitis. Participants in this trial will receive dupilumab to evaluate its effectiveness specifically for allergic contact dermatitis. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Adults with strong allergic reactions to contact allergens, diagnosed with allergic contact dermatitis not responding well to topical treatments and avoidance. They must be able to consent and participate fully in the study. Excluded are those on recent immune medications, pregnant or breastfeeding women not using birth control, residents outside certain states, unable to use Zoom, prior dupilumab users, or with conditions that could affect the trial.

Inclusion Criteria

At least one contact allergen with a 2+ (strong) or 3+ (extreme reaction) confirmed by patch testing within 6 months of the baseline visit that can be duplicated at the initiation of the study (placement at Week 0 and patch test reaction read at Week 0 +72-120 hours)

Allergic contact dermatitis diagnosed clinically by the principle investigators who have expertise in allergic contact dermatitis

Documented recent history (within 18 months of patch testing) of inadequate response to treatment with topical medications and allergen avoidance

Exclusion Criteria

Treatment with a systemic immune-regulating medication within 3 months of the baseline visit or the patient's prior patch testing, whichever is longer

Treatment with other biologic agents, such as TNF inhibitors, anti-IL 17 agents, anti-IL 12/23 agents, or anti-IL 23 agents, within 4 months of baseline visit or the patient's prior patch testing, whichever is longer

Treatment with topical corticosteroids or topical calcineurin inhibitors within 1 week before the baseline visit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dupilumab for 10 weeks, with initial dose of 600 mg followed by 300 mg every 2 weeks

10 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab

Trial Overview The trial is testing Dupilumab's effectiveness for treating allergic contact dermatitis in adults who haven't responded well to other treatments. Participants will receive Dupilumab and their skin condition will be monitored to assess improvements.

How Is the Trial Designed?

Group I: Subjects with Allergic Contact Dermatitis Experimental Treatment 1 Intervention

Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks

Dupilumab is already approved in United States, European Union for the following indications:

Approved in United States as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Approved in European Union as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Published Research Related to This Trial

In a study of 818 adults with moderate-to-severe atopic dermatitis treated with dupilumab for at least 16 weeks, 12% of patients successfully spaced their doses or withdrew treatment while still maintaining effectiveness.

Key predictors for successful dose spacing or treatment withdrawal included having non-cutaneous atopic manifestations, a prurigo nodularis phenotype, and being older at the start of treatment, suggesting specific patient profiles can benefit from adjusted treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. Chiricozzi, A., Dal Bello, G., Gori, N., et al.[2023]

Dupilumab is an effective treatment for atopic dermatitis, showing significant improvements in skin symptoms and overall disease control in clinical trials.

The medication works by inhibiting specific pathways in the immune system, which helps reduce inflammation and alleviate the symptoms of atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. D'Ippolito, D., Pisano, M.[2020]

In a study of 46 adult patients with moderate-to-severe atopic dermatitis treated with dupilumab, 34.8% experienced ocular adverse events (OAEs), primarily mild to moderate dry eye disease and superficial punctate keratitis.

Patients with pre-existing conditions such as dry eye disease, eyelid eczema, or high IgE levels were more likely to develop OAEs, suggesting that these factors should be considered before starting dupilumab treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for dupilumab associated ocular adverse events: a real-life prospective study. Touhouche, AT., Cassagne, M., Bérard, E., et al.[2021]

Dupilumab is an effective treatment for type 2 inflammatory diseases like atopic dermatitis, asthma, and nasosinusal polyposis, as it inhibits the IL-4 receptor, blocking the action of key cytokines involved in these conditions.

The drug has a favorable safety profile, with few and reversible side effects, making it a promising option for patients who do not respond well to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dupilumab: beyond atopic dermatitis, off-label use in dermatology]. Russo, G., Laffitte, E.[2023]

Dupilumab is a monoclonal antibody that targets the IL-4 receptor, effectively inhibiting the action of IL-4 and IL-13, which are key players in allergic diseases.

It received its first approval in March 2017 for treating moderate-to-severe atopic dermatitis in adults who do not respond well to topical treatments, and is also being developed for asthma, nasal polyps, and eosinophilic esophagitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab: First Global Approval. Shirley, M.[2022]

Dupilumab is the first biological medication approved for treating moderate-to-severe atopic dermatitis, demonstrating significant effectiveness and a favorable safety profile.

Despite its overall safety, there have been rare cases of local Staphylococcus aureus infections reported in patients undergoing dupilumab treatment for atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: Dupilumab leads to an increased chance of head and neck Staphylococcus aureus infection in atopic dermatitis patients. Chen, M., Gao, K., Ali, K., et al.[2023]

In a study of 100 patients with atopic dermatitis, 36% of those treated with dupilumab developed ocular diseases, significantly higher than the 10% in the reference group.

Severe allergic conjunctivitis and blepharitis were notably more common in the dupilumab group, with 30% and 22% of patients affected, respectively, indicating a need for careful monitoring and potential ophthalmologist consultation before starting treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. Barbé, J., Poreaux, C., Remen, T., et al.[2021]

In a study of 60 patients with atopic dermatitis treated with dupilumab, serum TARC and LDH levels were strongly associated with changes in disease activity, indicating their potential as effective markers for monitoring treatment response.

The study highlights that the relevance of laboratory markers, such as IgE and eosinophil counts, varies depending on the treatment used, suggesting that dupilumab alters the relationship between these markers and disease activity compared to untreated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association study of transition of laboratory marker levels and transition of disease activity of atopic dermatitis patients treated with dupilumab. Mizuno, M., Horiguchi, G., Teramukai, S., et al.[2022]

Dupilumab (Dupixent) has been associated with a risk of ocular adverse reactions, highlighting the importance of monitoring patients for eye-related side effects during treatment.

Prompt management of any ocular issues is essential for patients receiving dupilumab, ensuring their safety and well-being while benefiting from the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety update: dupilumab and ocular adverse reactions. [2022]

Citations

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NCT02277769 | Study of Dupilumab (REGN668/ ... This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01548404

NCT01548404 | Study of Dupilumab in Adult Patients With ... The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK565242/table/cl.app1.tab3/

Clinical Review Report: Dupilumab (Dupixent) - NCBI Bookshelf Indicated for the treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with ...

4. investor.regeneron.com investor.regeneron.com/news-releases/news-release-details/sanofi-and-regeneron-report-positive-proof-concept-data

Sanofi and Regeneron Report Positive Proof-of-Concept ... Treatment with four weekly subcutaneous injections of dupilumab at either 150 milligrams (mg) or 300mg per week, significantly improved the signs and symptoms ...

5. annallergy.org annallergy.org/article/S1081-1206(25)00203-0/fulltext

Patient outcomes and safety of combination biologic ... Dupilumab has also exhibited efficacy in conditions not approved by Food and Drug Administration, including allergic contact dermatitis, hand dermatitis, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01639040

NCT01639040 | Study to Assess the Safety of Dupilumab ... The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to- ...

7. clinicaltrials.regeneron.com clinicaltrials.regeneron.com/clinical-trials/a0Mdy00000019m2EAA/nct01639040

Study to Assess the Safety of Dupilumab (REGN668 ... The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to- ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2017/761055Orig1s000PharmR.pdf

761055Orig1s000 - accessdata.fda.gov A Carcinogenicity Risk Assessment for Dupilumab (REGN668/ SAR231893). 2. Ex-Vivo Cross-Reactivity Study of REGN668 Monoclonal Antibody with a ...