Dupilumab for Allergic Contact Dermatitis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

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 18 years of age

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

+3 more

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

+9 more

Participant Groups

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.

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: