Dupilumab for Allergic Skin Reactions

Overseen By Nicole Nechiporchik

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Michigan

Must not be taking: Antibiotics, Antivirals, Antifungals, Antiparasitics

Disqualifiers: Asthma, COPD, Pregnancy, Cancer, 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: Unknown

10 Participants Needed

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.

Research Team

Mio Nakamura, MD, MS

Principal Investigator

University of Michigan

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.

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.

Treatment Details

Interventions

• Dupilumab

Trial Overview 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.

Participant Groups

Group I: Dupilumab Experimental Treatment 1 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:

• 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?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

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