9 Participants Needed

Dupilumab for Allergic Contact Dermatitis

LC
Overseen ByLiset Chacin, BA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the drug Dupilumab for allergic contact dermatitis?

Dupilumab has been shown to be effective in treating atopic dermatitis, a similar skin condition, by targeting specific proteins involved in inflammation. It has a favorable safety profile with few reversible side effects, suggesting potential effectiveness for allergic contact dermatitis as well.12345

Is dupilumab generally safe for humans?

Dupilumab is generally considered safe, but it can cause eye-related side effects like conjunctivitis (eye inflammation) and, in rare cases, more serious eye issues. It may also increase the risk of local skin infections in some patients.16789

How is the drug Dupilumab unique for treating allergic contact dermatitis?

Dupilumab is unique because it is a monoclonal antibody that targets the IL-4 and IL-13 pathways, which are involved in allergic inflammation. This mechanism is different from traditional treatments that often focus on topical therapies, making it a novel option for conditions like allergic contact dermatitis.125810

What is the purpose of this trial?

The aim of this study is to investigate the effects of dupilumab on allergic contact dermatitis.

Eligibility Criteria

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
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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
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Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Subjects with Allergic Contact DermatitisExperimental Treatment1 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

Find a Clinic Near You

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 profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Findings from Research

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

References

Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. [2021]
Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. [2023]
[Dupilumab: beyond atopic dermatitis, off-label use in dermatology]. [2023]
Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. [2020]
Dupilumab: First Global Approval. [2022]
Safety update: dupilumab and ocular adverse reactions. [2022]
Case report: Dupilumab leads to an increased chance of head and neck Staphylococcus aureus infection in atopic dermatitis patients. [2023]
Incidence and risk factors for dupilumab associated ocular adverse events: a real-life prospective study. [2021]
[Ocular symptoms associated with dupilumab in atopic dermatitis]. [2020]
Association study of transition of laboratory marker levels and transition of disease activity of atopic dermatitis patients treated with dupilumab. [2022]
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