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Monoclonal Antibodies

Dupilumab for Allergic Skin Reactions

Phase 4

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0, week 24

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0, 24weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Th2 immune cell population in lesional Dermal hypersensitivity reaction (DHR) skin at week 16 compared to week 0.

Secondary outcome measures

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

12%

Accidental Overdose

Conjunctivitis

Nasopharyngitis

Headache

Dermatitis Atopic

Fall

Multiple Fractures

100%

80%

60%

40%

20%

Study treatment Arm

DB Period: Placebo

OLE Period: Dupilumab/Dupilumab

DB Period: Dupilumab

OLE Period: Placebo/Dupilumab

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

~12230

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,378,128 Total Patients Enrolled

Regeneron PharmaceuticalsIndustry Sponsor

622 Previous Clinical Trials

380,721 Total Patients Enrolled

Mio Nakamura, MD, MSPrincipal InvestigatorUniversity of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has regulatory approval been granted for the use of Dupilumab?

"Dupilumab's safety is well-understood due to its Phase 4 trial status, earning it a score of 3."

Answered by AI

Is this research endeavor still accessible to participants?

"As per the information stored on clinicaltrials.gov, this medical experiment is not currently accepting patients. Though it was first posted on September 1st 2023 and last edited August 21st 2021, no new participants are required at present. Fortunately there are 279 other trials that presently require candidates to join their study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Immunologic Effects of Dupilumab in the Treatment of Dermal Hypersensitivity Reaction

Mio Nakamura 2023. "The Immunologic Effects of Dupilumab in the Treatment of Dermal Hypersensitivity Reaction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06012448.