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

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called dupilumab (also known as Dupixent) to determine its safety and effectiveness in treating ongoing allergic skin reactions, known as dermal hypersensitivity reactions. The goal is to better understand these skin reactions and how dupilumab might alleviate them. Individuals who have experienced these skin issues for at least six weeks without a known cause and have moderate-to-severe symptoms affecting daily life might be suitable candidates. As a Phase 4 trial, this research aims to explore how this already FDA-approved and proven effective treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the safety track record for this treatment?

Research shows that most people tolerate dupilumab well. Common side effects include injection site reactions and eye inflammation, but most people manage these effectively.

Studies have found that allergic reactions can occur, though they are rare. Dupilumab should not be used with live vaccines, so consider this if there are concerns about vaccines.

The FDA has already approved dupilumab for other conditions like eczema, indicating that its safety is well-understood. This trial examines its use for skin allergies to evaluate its effectiveness for this specific condition. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Dupilumab is unique because it targets the interleukin-4 receptor alpha, a key player in the inflammatory process of allergic skin reactions. Unlike traditional treatments like topical steroids or antihistamines, which often provide only temporary relief and can have side effects with prolonged use, dupilumab offers a targeted approach by directly interfering with the proteins responsible for inflammation. Researchers are excited about dupilumab because it has the potential to provide long-lasting relief with fewer side effects, addressing the root cause of allergic skin reactions rather than just managing symptoms.

What is the effectiveness track record for dupilumab in treating dermal hypersensitivity reactions?

Research has shown that dupilumab effectively treats skin conditions like eczema. In studies, over 75% of patients using dupilumab improved by 75% or more. These patients also required fewer additional eczema treatments. Furthermore, long-term evidence suggests that dupilumab continues to enhance skin symptoms and quality of life for several years. This supports the idea that dupilumab can effectively treat allergic skin reactions. ^{6 7 8 9 10}

Who Is on the Research Team?

Mio Nakamura, MD, MS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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.

Currently participating or participated in any other study of a drug or device, within the past 8 weeks before the screening visit, or is in an exclusion period (if verifiable) from a previous study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dupilumab injections to treat dermal hypersensitivity reaction

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10442302/

Long-Term Effectiveness of Dupilumab in Patients with Atopic ... Significant reductions from baseline were reported in concomitant AD therapy use (P < 0.05); 54.4% reported not using other AD medications vs.

2. dupixent.com dupixent.com/atopicdermatitis/dupixent-results/adults

DUPIXENT® (dupilumab) Results in Adults with Eczema Learn about the DUPIXENT® (dupilumab) clinical trial results for uncontrolled moderate-to-severe eczema in adults. Serious side effects can occur.

3. dupixenthcp.com dupixenthcp.com/atopicdermatitis/efficacy-safety/adult-real-world-results

Adult Real-World Data | DUPIXENT® (dupilumab) Real-world results in skin improvement at 4 years ... Long-term effectiveness of dupilumab in patients with atopic dermatitis: results up to 3 years from the ...

4. newsroom.regeneron.com newsroom.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-data-revolutionizing-atopic-dermatitis-rad

Dupixent® (dupilumab) Data at Revolutionizing Atopic ... Dupixent achieved 75% or greater improvement in overall disease severity, the primary endpoint, in more than three-quarters of treated patients.

5. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2820911

Dupilumab in Adults With Moderate to Severe Atopic ... These previous analyses demonstrated that dupilumab treatment for up to 4 years improved AD signs, symptoms, and quality of life, with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02277769

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 ...

7. dupixenthcp.com dupixenthcp.com/copd/efficacy-safety/safety-data

COPD Clinical Trials Safety Data Avoid use of live vaccines during treatment with DUPIXENT. ADVERSE REACTIONS: Most common adverse reactions are: Atopic Dermatitis (incidence ≥1%): injection ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK596600/

Clinical Review - Dupilumab (Dupixent) - NCBI - NIH Finally, it was noted that children on dupilumab cannot be vaccinated with live vaccines, which can pose challenges for children who are not fully immunized.

9. 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 ...

10. regeneron.com regeneron.com/downloads/dupixent_fpi.pdf

DUPIXENT® Full Prescribing Information The pooled safety data below reflects the safety of DUPIXENT ... DUPIXENT can cause allergic reactions, including skin reactions, that can sometimes be severe.