Your session is about to expire
← Back to Search
Dupilumab for Atopic Dermatitis
Study Summary
This trial is testing whether the drug dupilumab can improve sleep, itchiness, and circadian function in children 6-17 years old.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 4 trial • 188 Patients • NCT04033367Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- You are taking a medication that makes you feel itchy.I can communicate in English.I have used topical steroids within the last week.You haven't taken a shower or used moisturizers within 12 hours before the sleep test.I haven't taken any immune-weakening drugs in the last 30 days.I've had trouble sleeping due to allergies on 2 or more nights last week.You have trouble sleeping, as assessed by a specific test, or if you're under 8 years old, your parent has reported that you have trouble sleeping.I have a condition like sleep apnea or severe depression that affects my sleep.I have been on a stable dose of inhaled or topical steroids and antihistamines for at least 14 days.You have had an allergic reaction to dupilumab or any of its ingredients.I am clinically blind.I am between 6 and 17 years old.My eczema is severe and not controlled by creams or ointments.My skin condition is rated as moderate or severe.My asthma is not well-managed.I have a major medical condition like cancer.
- Group 1: Dupilumab administration
- 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.
- 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
Has Dupilumab been tested in other controlled trials?
"Currently, Dupilumab is the subject of 49 ongoing clinical trials - with 13 in Phase 3. Although most research sites are located in Palo Alto, California; this biologic therapy is being assessed at 2603 other places worldwide."
Is this a pioneering clinical trial?
"Presently, Dupilumab has 49 ongoing trials located in 43 countries and 436 cities. Sanofi initially sponsored the drug's clinical trial which began in 2015 with 880 patients; its Phase 3 stage was completed by conclusion of said year. Subsequently, 54 other studies have been conducted to date."
Is there still room to enroll participants in this trial?
"Affirmative. Details on clinicaltrials.gov verify that this medical trial is presently in search of participants and was initially posted November 1st 2022. An additional update occurred on July 19th 2022, with a goal to recruit 40 patients from two sites."
How many participants have been admitted to this clinical trial thus far?
"Indeed, as per the data hosted on clinicaltrials.gov, this research is presently recruiting individuals to participate in its trials. The study was first posted on November 1st 2022 and had a last update on July 19th 2022 - it seeks 40 people from two different locations."
What conditions is Dupilumab typically employed to address?
"Dupilumab is a viable medical solution for those suffering from dermatitis, atopic conditions, corticosteroid therapy failure and eosinophil."
Has the regulatory agency accepted Dupilumab for public use?
"Dupilumab is deemed a safe treatment, receiving a score of 3 due to its Phase 4 status. This indicates that this intervention has already been approved for medical use."
Does this research endeavor accept applicants aged 20 or older?
"This medical investigation is looking for participants who are between 6 and 17 years in age."
What is the overarching purpose of this clinical experiment?
"Over the course of 12 weeks, this trial will measure Wake After Sleep Onset as its primary outcome. To assess secondary outcomes, changes in PROMIS Pediatric Profile (general QOL), Children's Dermatology Life Quality Index (CDLQI) and percent Sleep Efficiency on PSG will be tracked from baseline to Week 12."
How can I participate in this clinical research?
"This clinical trial is currently recruiting 40 minors, aged 6 to 17, who are suffering from sleep disturbance. In order for patients to be included in the study they must meet a number of criteria including: having moderate or severe atopic dermatitis (as judged by vIGA score), being assessed or have parent-proxy PROMIS Sleep Disturbance T-score ≥60., being on stable regimens of inhaled corticosteroids and antihistamines 14 days prior to enrollment, and willing and able to comply with visits & study related procedures."
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger