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Monoclonal Antibodies

Dupilumab for Atopic Dermatitis

Phase 4
Recruiting
Led By Johann Gudjonsson, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderate-to-severe AD with involvement > 10% of body-surface-area (BSA) and investigator global assessment (IGA) score 3 at both the screening and baseline visits
Be older than 18 years old
Must not have
History of poor wound healing or keloid formation
Current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will investigate if there are differences in inflammatory responses to dupilumab between Caucasian, Asian, and African American patients with AD.

Who is the study for?
This trial is for adults with moderate-to-severe eczema (AD) covering more than 10% of their body. They must have had AD for at least two years and agree to use contraception or abstain from sex if they can have children. People with recent severe asthma, immune issues, certain infections including COVID-19, a history of cancer (except some skin cancers), substance abuse, or those on other trials can't join.
What is being tested?
The study tests how different ethnic groups (Caucasian, Asian, African American) respond to Dupilumab for treating eczema. It explores whether ethnicity affects inflammation and response to the drug that blocks a specific part of the immune system involved in allergic reactions.
What are the potential side effects?
Dupilumab may cause injection site reactions, eye problems like dryness or irritation, cold sores in your mouth or on your lips; and rarely more serious side effects such as allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My skin condition affects more than 10% of my body and is moderately to severely bad.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of poor wound healing or keloid formation.
Select...
I have chronic obstructive pulmonary disease or chronic bronchitis.
Select...
I have been treated with dupilumab before.
Select...
I have a skin condition that might affect the study.
Select...
My asthma has been poorly controlled for the last 3 months.
Select...
I was hospitalized for asthma in the last year.
Select...
I have an active or latent TB infection.
Select...
My body weight is under 30 kg.
Select...
I haven't had a skin infection or needed strong infection medicine in the last 2 weeks.
Select...
I am scheduled for a major surgery during the study.
Select...
My asthma control score is below 19.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
The 3 groups of patients (Asian, African American, and Caucasian) will all receive the same intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
FDA approved

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor
665 Previous Clinical Trials
385,711 Total Patients Enrolled
University of MichiganLead Sponsor
1,852 Previous Clinical Trials
6,432,712 Total Patients Enrolled
Johann Gudjonsson, MDPrincipal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
38 Total Patients Enrolled

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05268107 — Phase 4
Atopic Dermatitis Research Study Groups: Dupilumab
Atopic Dermatitis Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT05268107 — Phase 4
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05268107 — Phase 4
~0 spots leftby Dec 2024
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