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New treatment option for Atopic Dermatitis
Official title Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome
ClinicalTrials.gov ID: NCT07242638
What this study is testing
What is Abrocitinib?
Abrocitinib is an investigational medicine, given as an once-daily, being studied as a potential treatment for atopic dermatitis.
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
- This is a single-center, open-label, basket phase 2b trial that will enroll Down Syndrome (DS) participants with at least one inflammatory skin condition (Atopic Dermatitis (AD) and/or Alopecia Areata (AA)). Patients will receive Abrocitinib 100 mg daily for 12 weeks.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Participants must meet all of the following criteria to be eligible as study participants:
- Male or female participants who are at least 12 years old, for whom signed informed consent can be provided by parent or legal guardian/LAR prior to...
- Diagnosis of Trisomy 21 or translocation Down Syndrome.
- Participant is able to adhere to the study visit schedule and other protocol requirements.
- Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Week 0/Baseline. While on investigational product and...
You likely can't join if
- Participants who meet any of the following criteria are not eligible for randomization as study participants:
- Inability or unwillingness of a participant's parent or legal guardian/LAR to give written informed consent or comply with study protocol.
- Participant is pregnant or breastfeeding.
- Participants with AA: A. cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such as traction, cicatricial...
- Participant has increased risk of developing venous thromboembolism, e.g. deep vein thrombosis or pulmonary embolism (history of venous...
- Participant currently has active forms of other inflammatory skin diseases (eg, psoriasis, seborrheic dermatitis, lupus) at the time of Day 1 that...
See the full eligibility criteria
Who can join
- Participants must meet all of the following criteria to be eligible as study participants:
- Male or female participants who are at least 12 years old, for whom signed informed consent can be provided by parent or legal guardian/LAR prior to participation in any study assessments or procedures.
- Diagnosis of Trisomy 21 or translocation Down Syndrome.
- Participant is able to adhere to the study visit schedule and other protocol requirements.
- Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Week 0/Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational...
- Participant has a history of ≥6 months AD (≥7%BSA) or AA (≥25% scalp involvement). If the participant presents with both conditions, but only one meets the , then the participant can only be enrolled under that...
- Participant is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing.
What rules you out
- Participants who meet any of the following criteria are not eligible for randomization as study participants:
- Inability or unwillingness of a participant's parent or legal guardian/LAR to give written informed consent or comply with study protocol.
- Participant is pregnant or breastfeeding.
- Participants with AA: A. cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such as traction, cicatricial, pregnancy-related, druginduced, telogen effluvium, or advanced androgenetic...
- Participant has increased risk of developing venous thromboembolism, e.g. deep vein thrombosis or pulmonary embolism (history of venous thromboembolism, or first-degree relative with unprovoked venous thromboembolism...
- Participant currently has active forms of other inflammatory skin diseases (eg, psoriasis, seborrheic dermatitis, lupus) at the time of Day 1 that would interfere with evaluation of AD or AA.
- Participant was vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to Baseline visit, or is expected to be vaccinated or to have household exposure to these vaccines during treatment.
- Participant has a suspected or active lymphoproliferative disorder or malignancy; OR a history of malignancy within 5 years before the Week 0/Baseline assessment, except for completely treated in situ non-melanoma skin...
- Infection History: Participant has an active bacterial, viral, or helminth parasitic infection; OR a history of ongoing, recurrent severe infections requiring systemic antibiotics. Participant has active chronic or...
- Participant has a history of alcohol or substance abuse within 6 months prior to Day 1 that in the opinion of the investigator will preclude participation in the study.
- Participant with a known or suspected underlying immunodeficiency or immune-compromised state as determined by the investigator.
- Participant has a concurrent or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, intestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease. ANY of the...
- Participant has active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) prior to Baseline.
- Participant has positive or indeterminable PPD or QFT result including participants that completed standard tuberculosis therapy prior to Baseline.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
- Participant has history of adverse systemic or allergic reactions to any component of the study drug or any safety event deemed "related" to a JAK inhibitor.
- Participant has used systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, oral...
- Participant has used systemic monoclonal antibody treatments (such as the IL-4R antagonist dupilumab) within 12 weeks of Baseline visit.
- Participant has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus within 1 week prior to the Week 0/Baseline visit.
- Participant with Translocation or Mosaic Downs Syndrome.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, 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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, 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.