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NCT02299297 · ClinicalTrials.gov registry record · Phase 2
Study To Evaluate The Efficacy Of Tofacitinib In Moderate To Severe Alopecia Areata, Totalis And Universalis
A Phase 2 study of Alopecia Areata, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT02299297: Completed Phase 2 study of Alopecia Areata, sponsored by Columbia University.
NCT02299297 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. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02299297, 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
This is an open-label pilot study of tofacitinib taken daily for 6 months in the treatment of moderate to severe AA, and alopecia totalis or universalis, followed by 6 months follow-up off drug to assess the incidence and timing of recurrence of disease or documentation of delayed response to treatment. There will be the option of increasing the treatment duration up to an additional 6 months beyond the initially scheduled 6 months of treatment, if clinically indicated, and at the discretion of the investigator.
Primary Outcome
This is defined as 50% or greater hair re-growth from baseline as assessed by the Severity of ALopecia Tool (SALT) score after up to 24 weeks/6 months to 72 weeks/18 months of treatment. This is a relatively strict definition for defining responders and non-responders and was chosen to minimize the potential for spontaneous remission, in which fewer than 10% are expected to achieve this magnitude of hair regrowth spontaneously.
Conditions Studied
Interventions
- DRUG Tofacitinib
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2015-01 |
| Est. Completion | 2017-12 |
| Phase | Phase 2 |
What the finished NCT02299297 record still lists
NCT02299297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,955-participant average among 26 other Alopecia Areata trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Alopecia Areata appearing as the primary indexed condition, and to 1 intervention - of which Tofacitinib is the first listed.
NCT02299297 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02299297 about?
NCT02299297 is a clinical study titled "Study To Evaluate The Efficacy Of Tofacitinib In Moderate To Severe Alopecia Areata, Totalis And Universalis". This is an open-label pilot study of tofacitinib taken daily for 6 months in the treatment of moderate to severe AA, and alopecia totalis or universalis, followed by 6 months follow-up off drug to assess the incidence and timing of recurrence of disease or documentation of delayed response to treatm...
What is the current status of trial NCT02299297?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2015-01. Estimated completion is 2017-12.
What conditions does trial NCT02299297 study?
This clinical trial studies the following conditions: Alopecia Areata.
What interventions are being tested in trial NCT02299297?
The interventions under investigation include: Tofacitinib (DRUG).
Who is sponsoring clinical trial NCT02299297?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02299297 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02299297's enrollment target sits among peer trials
12 23rd of 26 higher than 2 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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