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New treatment option for Atopic Dermatitis
Official title Ethnic Differences in Mechanisms of Action of Dupilumab
ClinicalTrials.gov ID: NCT05268107
What this study is testing
What is Dupilumab?
Dupilumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for atopic dermatitis.
Also referred to as Dupixent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Previous research has shown that Asian and African Americans are more likely to develop atopic dermatitis (AD) than their Caucasian counterparts. However, limited information is known about AD in Asian and African American populations because most molecular studies have focused on Caucasians with AD.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Established diagnosis of AD for at least 2 years before the screening visit and confirmed according to the American Academy of Dermatology Consensus...
- Moderate-to-severe AD with involvement \> 10% of body-surface-area (BSA) and investigator global assessment (IGA) score 3 (based on the IGA scale...
- Female people of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree...
- Subject willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol
You likely can't join if
- Body weight less than 30 kilogram
- people meeting 1 or more of the following criteria at screening or baseline:
- Had an exacerbation of asthma requiring hospitalization in the preceding 12 months.
- Reporting asthma that has not been well-controlled (ie, symptoms occurring on \>2 days per week, nighttime awakenings 2 or more times per week, or...
- Asthma Control Test (ACT) \< 19 (only for people with a history of asthma).
- people with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
See the full eligibility criteria
- Established diagnosis of AD for at least 2 years before the screening visit and confirmed according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit
- Moderate-to-severe AD with involvement \> 10% of body-surface-area (BSA) and investigator global assessment (IGA) score 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the...
- Female people of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for 12...
- Subject willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol
- Body weight less than 30 kilogram
- people meeting 1 or more of the following criteria at screening or baseline:
- Had an exacerbation of asthma requiring hospitalization in the preceding 12 months.
- Reporting asthma that has not been well-controlled (ie, symptoms occurring on \>2 days per week, nighttime awakenings 2 or more times per week, or some interference with normal activities) during the preceding 3 months
- Asthma Control Test (ACT) \< 19 (only for people with a history of asthma).
- people with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
- Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.
- Confirmed or suspected coronavirus disease 2019 (COVID-19) infection within 4 weeks before the screening or baseline visit
- Received COVID-19 vaccination within 4 weeks before baseline visit
- Previous treatment with dupilumab
- Pregnant women (positive serum pregnancy test result at the screening visit or positive urine pregnancy test at the baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study
- History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of...
- History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, i.e., monoclonal antibody) or to lidocaine
- Known active or latent tuberculosis (TB) infection
- Known or suspected immunosuppression or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment
- History of or current confounding skin condition (i.e., Netherton syndrome, psoriasis, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], contact dermatitis, chronic actinic dermatitis, dermatitis...
- Planned or expected major surgical procedure during the study
- Currently participating or participated in any other study of a drug or device, within the past 8 weeks before the screening visit, or is in an exclusion period (if verifiable) from a previous study
- History of alcohol or substance abuse within 6 months of the screening
- History of poor wound healing or keloid formation
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.