Atopic Dermatitis study: Abrocitinib
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?
An investigational daily oral medicine being studied for atopic dermatitis in people with Down Syndrome. is designed to inhibit Janus kinase 1 (JAK1) signaling.
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
- The study wants to see if abrocitinib can improve atopic dermatitis or alopecia areata in this group.
- Who it's for
- It is looking for adults or children with Down syndrome who have at least one of those skin conditions.
- What's involved
- Participants will take 100 mg of abrocitinib every day for 12 weeks. If they do not reach a set improvement level, the dose may be increased to 200 mg for another 12 weeks. After that, they stay on the dose that worked until week 60.
- Time commitment
- The study lasts about 60 weeks, with daily medication and regular check‑ins (exact visit schedule not detailed).
- 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
- 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.
- Participant has a history of ≥6 months AD (≥7%BSA) or AA (≥25% scalp involvement).
You likely can't join if
- 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.
- Participant currently has active forms of other inflammatory skin diseases (eg, psoriasis, seborrheic dermatitis, lupus) at the time of Day 1 that...
- 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...
See the full eligibility criteria
- 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.
- 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.
- 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 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.