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Monoclonal Antibodies
Transcriptomic Skin Analysis for Atopic Dermatitis (LEADS Trial)
Phase 4
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant and/or parent guardian must be able to understand and provide informed consent and assent (if applicable)
Participants must agree to apply a stable dose of a study provided topical moisturizer (Vanicream (TM)) at least twice daily between the Baseline Assessment and Day 7 Visits to a specified skin target area
Timeline
Screening 1 day
Treatment 6 months
Follow Up 0 days
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Approved for 10 Other Conditions
Pivotal Trial
Summary
This trial will help researchers understand the different ways atopic dermatitis manifests, in order to better tailor treatments.
Who is the study for?
This trial is for individuals with mild to moderate-severe Atopic Dermatitis (AD). Eligible participants must understand and consent to the study, use FDA-approved birth control if applicable, apply Vanicream moisturizer twice daily, and adhere to asthma medications if they have asthma. Participants should not be pregnant or breastfeeding, have a history of certain cancers or keloids (adults), require systemic immunosuppressants recently, or have used other biologics or phototherapy close to the baseline visit.
What is being tested?
The study aims to analyze gene expression in skin samples from AD patients responding to standard treatments like topical steroids and Dupilumab. It will compare these profiles between mild and severe cases over ten visits. Non-AD participants are controls. The primary goal is seeing if a specific skin endotype correlates with AD severity.
What are the potential side effects?
Potential side effects may include irritation at the cream application site for Vanicream users; Triamcinolone could cause skin thinning or hormonal changes; Dupilumab might lead to injection site reactions, eye issues, or cold sores.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to regularly apply a specific moisturizer provided by the study.
Select...
I will continue my asthma medication throughout the study.
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I am not pregnant, as confirmed by tests at my first and second visits.
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I agree to use approved birth control methods during the study.
Timeline
Screening ~ 1 day1 visit
Treatment ~ 6 months6 visits
Follow Up ~ 0 days1 visit
Screening ~ 1 day
Treatment ~ 6 months
Follow Up ~0 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Non-lesional skin tape transcriptome at Day 7
Secondary study objectives
Non-lesional and lesional skin tape transcriptome at Day 7 and Days 168-224
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
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.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Experienced Dupilumab atopic dermatitis participantsExperimental Treatment1 Intervention
AD participants already on dupilumab (for >= 4 months prior to study entry (20 children, 40 adults)) at the start of the study will continue dupilumab treatment as prescribed by their physician outside of the study.
After Day 7, long-term dupilumab participants may continue to apply topical steroids/moisturizer body-wide as needed per their physician's orders and will return for assessments and sampling at Days 63 and 140. At Day 140, participants will discontinue applying topical steroids to the specified target area and begin to apply Vanicream™ at least twice daily on the target skin area until their End of Study Assessment visit (Day 168)
Group II: Dupilumab-naïve atopic dermatitis participantsExperimental Treatment2 Interventions
On Day 7, dupilumab-naïve AD participants will begin applying triamcinolone 0.1% ointment (provided by the study) twice daily to the specified target area. Additionally, dupilumab-naïve AD participants will apply triamcinolone 0.1% ointment (non-sensitive regions)/ hydrocortisone 2.5% ointment (sensitive regions) twice daily to active lesions on non-target skin.
Dupilumab-naïve AD participants will return for a Steroid Assessment Visit at Day 35, when response to triamcinolone will be evaluated at the target site by TAA and targeted EASI scoring, and overall management of AD body-wide by topical steroid/moisturizer treatment will be evaluated by EASI score.
Group III: Non-atopic dermatitis participantsActive Control1 Intervention
Approximately 150 will be non-AD controls (including approximately 50 children, 6-17 years of age, and 100 adults, = 18 years of age)
Non-AD control participants will return for assessment visits at Days 0, 7, 35, 91, 140, and 168. Non-AD participants will apply Vanicream (TM) at least twice daily to the specified target skin area starting at Day 140 through the End of Study Assessment Visit (Day 168)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
FDA approved
Triamcinolone
FDA approved
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,322 Previous Clinical Trials
5,364,138 Total Patients Enrolled
Donald Leung, M.D., Ph.D.Study ChairNational Jewish Health: Division of Pediatric Allergy and Clinical Immunology
2 Previous Clinical Trials
131 Total Patients Enrolled
Max A. Seibold, Ph.D.Study ChairNational Jewish Health: Division of Pediatric Allergy and Clinical Immunology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Parent or guardian must be able to understand and complete study-related questionnaires.I only have Atopic Dermatitis and no other skin conditions affecting my skin's outer layer.You have a history of heavy drinking or drug abuse within the past 2 years.I have never had keloids form after an injury or surgery.You have other medical issues or conditions that the researcher thinks might make it risky for you to participate in the study, that could make it hard for you to follow the study requirements, or could affect the study results. This includes having a known allergy to certain anesthetics, bleeding disorders, taking blood thinning medication, or having other conditions that make having a biopsy unwise.I haven't been in a drug trial or taken experimental drugs for the longer of 8 weeks or 5 half-lives before my first visit.I have not used phototherapy or visited a tanning booth in the last 4 weeks.I have not taken a bleach bath in the week before my first visit.I have not used a chlorinated hot tub in the week before my first check-up.I can start using certain moisturizers during the study if I haven't before.I weigh less than 15 kg.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that were fully treated.I will continue my asthma medication throughout the study.I haven't taken any cell-depleting drugs, like rituximab, in the last 6 months or until my lymphocyte counts returned to normal.I have been diagnosed with HIV.I have a history of non-cancerous conditions that affect my lymph nodes.I agree to use approved birth control methods during the study.I agree to regularly apply a specific moisturizer provided by the study.I haven't had a parasitic infection (other than vaginal trichomoniasis) in the last year and am not at high risk for one.I am not planning any major surgeries that could interfere with the study.I have not taken antibiotics or antivirals for an infection in the last 4 weeks.I haven't taken any immune system altering drugs in the last 4 weeks.I agree to use approved birth control methods during the study.I agree to regularly apply a specific moisturizer provided by the study.I have asthma and needed steroids recently or take a high dose of inhaled steroids.I have not had a live vaccine in the last 6 weeks and won't get one during the study.I haven't taken specific immune treatments in the last 16 weeks.I have skin lesions large enough for testing and have never used Dupilumab.I have been on dupilumab for at least 4 months.I am not pregnant, as confirmed by tests at my first and second visits.I haven't taken any biologic drugs for at least 16 weeks or 5 half-lives, whichever is longer.I agree not to use steroid creams on a specific area until after Day 7.I have had chronic atopic dermatitis for at least 1 year.I am not pregnant, as confirmed by tests at my first and second visits.I will continue my asthma medication throughout the study.You have had a severe and life-threatening reaction to medical tape or adhesives in the past.You are allergic to any of the ingredients in the study treatments, including Vanicream (TM), hydrocortisone, triamcinolone, or dupilumab.You have an eye condition that could put you at risk during the study, such as a history of herpes keratitis, Sjogren's Syndrome, Keratoconjunctivitis Sicca or Dry Eye Syndrome that requires daily use of additional lubrication or the regular use of ocular corticosteroids or cyclosporine.
Research Study Groups:
This trial has the following groups:- Group 1: Dupilumab-naïve atopic dermatitis participants
- Group 2: Experienced Dupilumab atopic dermatitis participants
- Group 3: Non-atopic dermatitis participants
Awards:
This trial has 5 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.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
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