Treatment of Atopic Dermatitis and Alopecia Areata With Abrocitinib in Individuals With Down Syndrome

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Mar 1, 2027 → Feb 23, 2029
See other at-risk trials from Icahn School of Medicine at Mount Sinai

Record History

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  1. Primary completion pushed from Mar 1, 2027 to Feb 23, 2029 Show 4 more changesShow less
    • Study completion pushed from Mar 3, 2028 to Feb 23, 2029
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Study description revised
  2. Start date changed from estimate of Jan 5, 2026 to Jan 12, 2026v3
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07242638
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: Columbia University, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions
(from sponsor)		 Atopic Dermatitis, Alopecia Areata
Related terms Alopecia Areata, Dermatitis, Atopic, Down Syndrome
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov