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NCT01950780 · ClinicalTrials.gov registry record · Phase 2
Pilot Study to Evaluate the Efficacy of Ruxolitinib in Alopecia Areata
A Phase 2 study of Alopecia Areata, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01950780 is a Phase 2 study of Alopecia Areata that has completed, run by Columbia University. The registered enrollment target is 12 participants, below the 1,955-participant average among 26 other Alopecia Areata trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01950780, a Phase 2 study of Alopecia Areata, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Alopecia areata (AA) is a common disease of the immune system, known as an "autoimmune" disease. In the disease, the immune system mistakenly destroys the hair follicle, causing hair to fall out. Despite many people having this disease, research into its cause and into new, better ways to treat AA has lagged far behind other similar diseases of the immune system. Currently, there are no Federal Drug Administration approved drugs for AA. Ruxolitinib (made by Incyte) is an intervention known to effectively treat a disease of the bone marrow, known as myelofibrosis. It is also being studied in the treatment of rheumatoid arthritis, another "autoimmune" disease, by fighting inflammation. There are some genetic and chemical similarities between those with myelofibrosis, active rheumatoid arthritis and AA, suggesting that treatment with ruxolitinib may be effective in AA. In mice specially designed for testing drugs for the treatment of human alopecia areata, this medication worked to prevent the disease AA from starting in mice that would have otherwise developed the disease. To test Ruxolitinib, we are going to treat 12 patients with moderate to severe AA for a minimum of 3 months up to 6 months. This is an "open-label" study, meaning that there will not be a placebo group; all patients enrolled in the study will receive the active medication. The effectiveness of the medication will be measured by changes in hair re-growth as determined by physical exam and photography, as well as by patient and physician scoring. Patients will be followed for another 3 months off of the drug to see if the effects of treatment last and if there is delayed response. The safety of the medication, ruxolitinib, in patients with alopecia areata will also be evaluated. Blood work will be collected before medication is started, during the treatment period, and after ruxolitinib is stopped, in order to monitor for adverse effects of the medication. Small scalp biopsies and peripheral blood w
Conditions Studied
Interventions
- DRUG Ruxolitinib
Study Locations (1)
New York
- Columbia University Medical Center, Department of Dermatology - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-08 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01950780
The ClinicalTrials.gov registry entry for NCT01950780 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,955-participant average among 26 other Alopecia Areata trials with a reported enrollment target (99% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alopecia Areata appearing as the primary indexed condition, and to 1 intervention - of which Ruxolitinib is the first listed.
NCT01950780 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01950780 about?
NCT01950780 is a clinical study titled "Pilot Study to Evaluate the Efficacy of Ruxolitinib in Alopecia Areata". Alopecia areata (AA) is a common disease of the immune system, known as an "autoimmune" disease. In the disease, the immune system mistakenly destroys the hair follicle, causing hair to fall out. Despite many people having this disease, research into its cause and into new, better ways to treat AA h...
What is the current status of trial NCT01950780?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2013-08. Estimated completion is 2016-04.
What conditions does trial NCT01950780 study?
This clinical trial studies the following conditions: Alopecia Areata.
What interventions are being tested in trial NCT01950780?
The interventions under investigation include: Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT01950780?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01950780 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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