Actively Recruiting
Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-02-02
56
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
C
Columbia University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Responders (defined as achieving Eczema Area and Severity Index (EASI) 75 response for AD, or SALT \<= 20 for AA) will be kept on this dose, and non-responders based on these definitions, will initiate 200 mg daily for another 12 weeks. All AD and AA patients will be maintained on the respective dose of Abrocitinib from Week 24 through week 60.
CONDITIONS
Official Title
Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 12 years or older with signed informed consent by parent or legal guardian
- Diagnosis of Trisomy 21 or translocation Down Syndrome
- Ability to follow the study visit schedule and protocol requirements
- Females of childbearing potential must have negative pregnancy tests at screening and baseline and use approved contraception during and 28 days after treatment
- History of at least 6 months of Atopic Dermatitis with 7% or more body surface area, or Alopecia Areata with 25% or more scalp involvement
- Good overall health based on medical history, physical exam, and lab tests
You will not qualify if you...
- Inability or unwillingness of parent or guardian to provide consent or comply with the study
- Current pregnancy or breastfeeding
- For AA patients: unclear cause of hair loss or other types of alopecia; no hair regrowth for 7 or more years since last episode
- Increased risk of venous thromboembolism due to personal or family history
- Active other inflammatory skin diseases that interfere with AD or AA evaluation
- Recent vaccination or exposure to live or attenuated vaccines within 6 weeks prior to baseline
- Suspected or active lymphoproliferative disorder or malignancy within 5 years, except certain treated skin or cervical cancers
- Active or recent serious infections including bacterial, viral, parasitic, or skin infections
- History of herpes infections as specified
- History of alcohol or substance abuse within 6 months
- Known or suspected immune deficiency
- Severe or uncontrolled major organ diseases or abnormal renal or liver test results
- Active hepatitis B, C, or HIV infection
- Positive or unclear tuberculosis screening
- Other medical issues deemed unsafe or interfering by investigator
- History of allergic reactions to study drug components or JAK inhibitors
- Use of systemic immunosuppressive drugs, monoclonal antibodies, or certain topical treatments within specified recent time frames
- Diagnosis of Translocation or Mosaic Down Syndrome
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
G
Giselle Singer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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