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Ruxolitinib for Hair Regrowth in APECED-Associated Alopecia Areata

This study is testing if ruxolitinib (Jakafi) can help hair regrow in people with Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED) who also have severe alopecia areata (AA), a type of hair loss. APECED is an immune system problem where the body mistakenly attacks itself. Ruxolitinib is already approved for other conditions. The study will also look at how safe ruxolitinib is. To be eligible, you must be between 12 and 75 years old, have APECED and severe AA (meaning at least 50% scalp hair loss), and have had hair loss for over six months. The main goal is to see if participants have at least a 30% improvement in their hair loss score after 32 weeks.

Study design
This is an open-label study, meaning you and your doctors will know you are receiving ruxolitinib. It plans to enroll 70 participants.
What's involved
You will be in the study for up to 10 months, with 5 in-person visits and 6 virtual visits. One in-person visit may involve a hospital stay of up to 10 days.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome for hair regrowth is measured at 32 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05398809

Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata

Recruiting
PHASE2Ages 12–75InterventionalTreatment
National Institute of Allergy and Infectious Diseases (NIAID)
~70 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Ruxolitinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response defined as a 30% improvement from baseline in the Severity of Alopecia Tool (SALT) score at 32 weeks.
Measured over 32 weeks

Conditions

Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced)
Alopecia Areata

Explore related trials

AlopeciaAutoimmune Polyglandular Syndrome Type 1

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Michail S Lionakis, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

Who to contact

Michail S Lionakis, M.D.
[email protected]
Not Listed
Email the study team

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What this trial measures

  • Response defined as a 30% improvement from baseline in the Severity of Alopecia Tool (SALT) score at 32 weeks.32 weeks

    To evaluate the efficacy of ruxolitinib on hair regrowth in participants with APECED-associated AA