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NCT05398809 · ClinicalTrials.gov registry record · Phase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
A Phase 2 study of Alopecia Areata and Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT05398809: Recruiting Phase 2 study of Alopecia Areata and Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05398809 is a Phase 2 study of Alopecia Areata and Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced) that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 70 participants, below the 1,953-participant average among 26 other Alopecia Areata trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05398809, a Phase 2 study of Alopecia Areata and Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (APECED) is a problem of the immune system. In people with APECED, the immune system makes a mistake and attacks the body. Some people with APECED have a type of hair loss called alopecia areata (AA). No drugs are approved to treat AA. Objective: To see if a study drug (ruxolitinib) can help hair regrowth in people with APECED-associated AA and if it can improve other symptoms caused by the immune system s attack to the body. Eligibility: People aged 12 to 65 years with APECED and severe AA. Design: Participants will be in this study for up to 10 months. They will have 5 in-person visits and 6 televisits, each about 4 weeks apart. One in-person visit may be up to a 10-day stay in the hospital. The first in-person visit will include screening. Participants will have a physical exam. They will have blood tests. Photographs may be taken of their skin. They will answer questions about their quality of life. Participants will begin taking the study drug during their hospital stay. They will take the pills by mouth twice a day for 8 months. Researchers may take tissue samples from participants scalp, gums, and lower lip. Participants may provide samples of urine, stool, nail clippings, and saliva. They may have an eye exam and an ultrasound exam of their abdomen. Some tests may be repeated in subsequent in-person visits. In telehealth visits, participants will answer questions about how they are feeling. They will describe and send photos of hair regrowth. They will be asked to have blood drawn and the results sent to the researchers.
Primary Outcome
To evaluate the efficacy of ruxolitinib on hair regrowth in participants with APECED-associated AA
Conditions Studied
Interventions
- DRUG Ruxolitinib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-01-18 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 2 |
What NCT05398809 shows while recruiting
NCT05398809 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,953-participant average among 26 other Alopecia Areata trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Alopecia Areata appearing as the primary indexed condition, and to 1 intervention - of which Ruxolitinib is the first listed.
NCT05398809 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05398809 about?
NCT05398809 is a clinical study titled "Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata". Background: Autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (APECED) is a problem of the immune system. In people with APECED, the immune system makes a mistake and attacks the body. Some people with APECED have a type of hair loss called alopecia areata (AA). No drugs are approved t...
What is the current status of trial NCT05398809?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2023-01-18. Estimated completion is 2027-12-01.
What conditions does trial NCT05398809 study?
This clinical trial studies the following conditions: Alopecia Areata, Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced).
What interventions are being tested in trial NCT05398809?
The interventions under investigation include: Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT05398809?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05398809 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05398809's enrollment target sits among peer trials
70 18th of 26 higher than 9 of 26 other Alopecia Areata trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alopecia Areata trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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