NCT07242638

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

Use of Specific JAK Inhibition on Inflammatory Skin and Scalp Diseases in Down Syndrome R61AR084210

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a single-center, open-label, basket phase 2b trial that will enroll DS subjects with at least one inflammatory skin condition (Atopic Dermatitis \[AD\] and/or Alopecia Areata \[AA\]). As our goal is to have 51 patients complete the study, with an estimated dropout rate of \~10%, we will enroll a total of n=56 patients. Patients will receive abrocitinib 100 mg daily for 12 weeks. Responders (defined as achieving EASI75 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 their respective dose of abrocitinib from Week 24 through week 60. Patients with AD and AA will have clinical evaluations as well as skin and blood specimens collected for molecular analysis at multiple time points. For AD patients, lesional and non-lesional tape strips will be collected at weeks 0, 12, 24, 48 and 60, and processed as we previously published. For AA patients, optional 2mm biopsies will be collected from lesional and non-lesional scalp at baseline and from lesional scalp at weeks 24 and 48. Blood samples (a total of 17mL at each visit, with 12mL dedicated to mechanistic analyses), will be collected at weeks 0, 12, 24, 36, 48, and 60.

Conditions

• Atopic Dermatitis
• Alopecia Areata

Interventions

Type	Name	Description
DRUG	Abrocitinib	All participants will be started on 100mg Abrocitinib daily. Based on clinical response, non-responders will be increased to 200mg daily at week 12. Responders will continue to receive 100 mg dose of Abrocitinib. All AA and AD participants will be maintained on their dose of Abrocitinib through week 60.

Timeline

• Start date: 2026-01-12
• Primary completion: 2027-03-01
• Completion: 2028-03-03
• First posted: 2025-11-21
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study