Dupilumab for Allergic Skin Reactions

Recruiting in Palo Alto (17 mi)

Overseen byMio Nakamura, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Michigan

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This research is studying a drug called dupilumab to learn about its safety and its effect as a treatment for participants with dermal hypersensitivity reaction. This study will help better understand why and how dermal hypersensitivity reaction occurs and how dupilumab might help treat this condition.

Eligibility Criteria

This trial is for individuals with a chronic idiopathic dermal hypersensitivity reaction (DHR) lasting at least 6 weeks, covering more than 5% of their body and moderately-to-severely affecting them. Women who can have children must avoid pregnancy during the study. Participants should not have tuberculosis, poorly controlled asthma, certain lung diseases, recent infections or COVID-19, cancer history within 5 years (with exceptions), planned surgeries, drug trials in the last 8 weeks, substance abuse history within 6 months, poor wound healing tendencies or previous dupilumab treatment.

Inclusion Criteria

I agree to use birth control or practice abstinence during and for 12 weeks after the study.

I have been diagnosed with chronic idiopathic DHR for at least 6 weeks.

You have at least 5% body surface area affected with a severity of 3 or more, as determined by the IGA scale.

+1 more

Exclusion Criteria

I was hospitalized for asthma in the last year.

You have had a severe allergic reaction in the past to a medication called immunoglobulin or lidocaine.

I am not planning to undergo any major surgeries during the study.

+13 more

Participant Groups

The trial is testing Dupilumab's safety and effectiveness on treating DHR to understand how it works against this allergic skin condition. It aims to uncover why DHR occurs and how Dupilumab may alleviate it.

1Treatment groups

Experimental Treatment

Group I: DupilumabExperimental Treatment1 Intervention

All patients will receive dupilumab.

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

🇺🇸 Approved in United States as Dupixent for: