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Monoclonal Antibodies

Dupilumab for Allergic Skin Reactions

Phase 4
Waitlist Available
Led By Mio Nakamura, MD, MS
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female subjects of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for 12 weeks after the last study drug injection, when this is in line with the preferred and usual lifestyle of the subject, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
Be older than 18 years old
Must not have
Had an exacerbation of asthma requiring hospitalization in the preceding 12 months.
Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 24
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is looking at a drug, dupilumab, to treat dermal hypersensitivity reactions and understand how it works.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Dupilumab could potentially cause side effects such as inflammation of organs like the skin or eyes (eczema or conjunctivitis), injection site reactions (redness or swelling), headache, cold sores in your mouth or throat (oral herpes), joint pain (arthralgia), and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use birth control or practice abstinence during and for 12 weeks after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was hospitalized for asthma in the last year.
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I have chronic obstructive pulmonary disease or chronic bronchitis.
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I am not planning to undergo any major surgeries during the study.
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My asthma symptoms have been frequent and disruptive in the last 3 months.
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I have been treated with dupilumab before.
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I do not have a skin condition like eczema, psoriasis, or chronic hives.
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I have an active or latent TB infection.
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I have a history of poor wound healing or keloid formation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, 24weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, 24weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Changes in Investigator Global Assessment (IGA) in patients with DHR treated with dupilumab at week 2 from week 0.
Changes in Investigator Global Assessment in patients with DHR treated with dupilumab at week 16 from week 0.
Changes in Investigator Global Assessment in patients with DHR treated with dupilumab at week 24 from week 0.
+13 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
9%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab
OLE Period: Dupilumab/Dupilumab

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DupilumabExperimental Treatment1 Intervention
All patients will receive dupilumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~11960

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,853 Previous Clinical Trials
6,433,015 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
668 Previous Clinical Trials
386,063 Total Patients Enrolled
Mio Nakamura, MD, MSPrincipal InvestigatorUniversity of Michigan
~4 spots leftby Aug 2025
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