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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 to week 16
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My skin condition affects more than 10% of my body and is moderately to severely bad.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0 to week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 to week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in inflammatory response to dupilumab between Caucasian, Asian and African American patients with atopic dermatitis as measured by change in expression of interleukin4 (IL4) from week 0 to 2.
Secondary outcome measures
Dermatitis, Atopic
Difference in inflammatory response to dupilumab between Caucasian, Asian and African American patients with atopic dermatitis as measured by change in expression of Interferon (IFN) from week 0 to 2.
Difference in inflammatory response to dupilumab between Caucasian, Asian and African American patients with atopic dermatitis as measured by change in expression of interleukin13 from week 0 to 16.
+4 moreSide effects data
From 2021 Phase 4 trial • 188 Patients • NCT040333679%
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
OLE Period: Placebo/Dupilumab
DB Period: Dupilumab
OLE Period: Dupilumab/Dupilumab
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
620 Previous Clinical Trials
380,355 Total Patients Enrolled
University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,378,028 Total Patients Enrolled
Johann Gudjonsson, MDPrincipal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
38 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My skin condition affects more than 10% of my body and is moderately to severely bad.I have a history of poor wound healing or keloid formation.I have or might have had COVID-19 in the last 4 weeks.I have been diagnosed with atopic dermatitis for over 2 years.I haven't had cancer, except for specific skin or cervical cancers, in the last 5 years.I have chronic obstructive pulmonary disease or chronic bronchitis.I have been treated with dupilumab before.I have a skin condition that might affect the study.My asthma has been poorly controlled for the last 3 months.I received a COVID-19 vaccine within the last 4 weeks.I agree to not get pregnant or use birth control during and for 12 weeks after the study.I was hospitalized for asthma in the last year.You have a weakened immune system or get sick very often.You have had a severe allergic reaction to a type of medication made from plasma or through genetic engineering, or to lidocaine.I have an active or latent TB infection.My body weight is under 30 kg.You have had issues with alcohol or drug abuse in the past six months.I haven't had a skin infection or needed strong infection medicine in the last 2 weeks.I am scheduled for a major surgery during the study.My asthma control score is below 19.
Research Study Groups:
This trial has the following groups:- Group 1: Dupilumab
Awards:
This trial has 4 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have signed up to take part in this clinical trial?
"Affirmative. Information on clinicaltrials.gov reveals that this trial is currently recruiting patients; the initial post was made October 1st 2022 and it was most recently updated September 7th 2022. Presently, there are 30 openings for subjects at a single site."
Answered by AI
Are there any current opportunities for individuals to participate in this experiment?
"According to clinicaltrials.gov, this research is currently enrolling participants with the initial posting date of October 1st 2022 and last update on September 7th 2022."
Answered by AI
Has the FDA sanctioned Dupilumab?
"Dupilumab is approved for medical use, so it has been given a score of 3 in terms of safety."
Answered by AI
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