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Monoclonal Antibodies
Dupilumab for Eczema
Phase 4
Recruiting
Led By Wilson Liao, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age
10% body surface area (BSA) or greater
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Study Summary
This trial will study the effects of the drug dupilumab on people with atopic dermatitis.
Who is the study for?
Adults with chronic atopic dermatitis (eczema) for over 3 years, severe enough to need phototherapy or systemic treatment. They must have a significant area of their body affected and a certain severity score. Participants should be able to consent, follow the study plan, and not likely to get pregnant or are using effective contraception.Check my eligibility
What is being tested?
The trial is testing Dupilumab's effects on the immune system and genes in skin lesions caused by atopic dermatitis. It's an open-label study where everyone gets Dupilumab; there’s no comparison group.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed, common ones from Dupilumab include injection site reactions, eye problems like redness or itching, cold sores in your mouth or on your lips.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
At least 10% of my body is affected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CD4+ T effector cells expressing IL-4
Secondary outcome measures
Microbiome
Number of differentially expressed genes and pathways
Side 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
OLE Period: Placebo/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Dupilumab/Dupilumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dupilumab treatmentExperimental Treatment1 Intervention
15 subjects will receive dupilumab for a treatment period of 52 weeks (i.e. last injection on week 50). All subjects will undergo skin biopsies for molecular profiling.
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
626 Previous Clinical Trials
381,933 Total Patients Enrolled
35 Trials studying Eczema
13,353 Patients Enrolled for Eczema
SanofiIndustry Sponsor
2,167 Previous Clinical Trials
3,516,398 Total Patients Enrolled
42 Trials studying Eczema
15,916 Patients Enrolled for Eczema
University of California, San FranciscoLead Sponsor
2,514 Previous Clinical Trials
15,244,404 Total Patients Enrolled
3 Trials studying Eczema
68 Patients Enrolled for Eczema
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any cell-depleting drugs or other biologics recently.I have other health conditions that won't affect my participation in this study.I have used a topical corticosteroid or calcineurin inhibitor within the last week.I am under 18 years old.My eczema is mild and I can't have light therapy or systemic treatments.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that were fully treated.Your eczema is very severe, with a score of 16 or higher on a special test.You have a history of weakened immune system, including HIV.I have severe health conditions alongside my main illness.At least 10% of my body is affected.My recent physical exam showed no major health issues.I haven't used any immune system affecting drugs or phototherapy in the last 4 weeks.I have had chronic atopic dermatitis for 3 years or more.I am 18 years old or older.I am eligible for light or systemic treatment.I have a serious infection.Your skin condition is rated as moderate or severe by the investigator.I cannot become pregnant due to being male, post-menopausal, or using effective birth control.I have had atopic dermatitis for less than 3 years.My severe atopic dermatitis is well controlled with my current treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Dupilumab treatment
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
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.
What other experimental studies have included Dupilumab in their research?
"Currently, 49 clinical trials are underway assessing the efficacy of Dupilumab. Of these experiments, 13 have entered Phase 3 testing. Palo Alto is hosting a large amount of this research; however, across the world there are 2603 different sites devoted to studying Dupilumab's effects."
Answered by AI
Has Dupilumab managed to pass the necessary regulatory requirements to become officially sanctioned?
"The safety of Dupilumab, which has been approved by medical authorities, was rated as a 3 on our team's scale."
Answered by AI
Are there any open spots left for participants in this experiment?
"Affirmative. According to clinicaltrials.gov, this medical research is presently recruiting participants which were initially posted on October 22nd 2018 and modified most recently on August 4th 2021. Approximately 15 individuals need to be gathered from 1 location."
Answered by AI
What is the total enrollment number for this clinical trial?
"Affirmative. Information hosted on clinicaltrials.gov reveals that this medical experiment has been recruiting since October 22nd 2018, with the latest amendment made on August 4th 2021. To complete their research objectives, they need 15 subjects from one site to participate in their trial."
Answered by AI
What medical disorders is Dupilumab commonly employed to treat?
"Dupilumab can be prescribed to individuals with atopic dermatitis, eosinophilia, and an intolerance of corticosteroid treatment."
Answered by AI
Does this clinical trial represent a pioneering approach to treatment?
"Since 2015, Dupilumab has been the subject of multiple research trials sponsored by Sanofi. Initially trialling 880 people in that year, the drug was approved for Phase 3 use shortly after. Currently there are 49 active clinical studies taking place across 436 cities and 43 nations worldwide."
Answered by AI
Who else is applying?
What site did they apply to?
UCSF Psoriasis and Skin Treatment Center
What portion of applicants met pre-screening criteria?
Met criteria
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