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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07242638
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abrocitinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 12, 2026
Status verified
Jan 2026
Primary completion
Mar 1, 2027
Completion
Mar 3, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open Label Abrocitinib
    Participants with DS with either AD or AA will be given Abrocitinib 100mg. In the case where patients is not responsive to treatment at Week 12 per protocol defined non-responder criteria, the treatment dosage will change to Abrocitinib 200 mg.

Primary Outcome Measure

Rate of Serious Adverse Events (SAEs) at Week 24 and Week 60 [ Time Frame: Week 24 and Week 60 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Giselle Singer
[email protected]
212-241-3288
Emma Guttman (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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