Trial Outcomes & Findings for Pilot Study to Evaluate the Efficacy of Ruxolitinib in Alopecia Areata (NCT NCT01950780)

NCT ID: NCT01950780

Last Updated: 2019-05-07

Results Overview

Severity of Alopecia Tool Score (SALT) calculation is based on a scoring system. The scalp is divided into the following 4 areas: 1) Vertex: 40% (0.4) of scalp surface area, 2) Right profile of scalp: 18% (0.18) of scalp surface area, 3) Left profile of scalp: 18% (0.18) of scalp surface area, and 4) Posterior aspect of scalp: 24% (0.24) of scalp surface area. The percentage of hair loss in any of these areas is the percentage hair loss multiplied by percent surface area of the scalp in that area. The SALT score is the sum of percentage of hair loss in all the above-mentioned areas, so a lower number indicates a better outcome. The reported SALT score range is from a minimum of 0 (no hair loss) to a maximum of 100 (100% hair loss).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Baseline, 3 months and 6 months

Results posted on

2019-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Ruxolitinib A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects. Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study to Evaluate the Efficacy of Ruxolitinib in Alopecia Areata

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ruxolitinib n=12 Participants A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects. Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months and 6 months

Outcome measures

Outcome measures
Measure	Ruxolitinib n=12 Participants A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects. Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.
Change in SALT Score Baseline	65.8 score on a scale Standard Deviation 28.0
Change in SALT Score 3 months	24.8 score on a scale Standard Deviation 22.9
Change in SALT Score 6 months	7.3 score on a scale Standard Deviation 13.5

SECONDARY outcome

Timeframe: Up to 6 months

Mean percentage of regrowth was calculated at the end of treatment for all subjects.

Outcome measures

Outcome measures
Measure	Ruxolitinib n=12 Participants A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects. Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.
Percentage of Regrowth	68.9 percentage of regrowth Standard Deviation 42.6

Adverse Events

Ruxolitinib

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ruxolitinib n=12 participants at risk A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects. Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.
Infections and infestations upper respiratory infection	41.7% 5/12 • Number of events 7 • 9 months per patient
Blood and lymphatic system disorders low hemoglobin	8.3% 1/12 • Number of events 1 • 9 months per patient
Skin and subcutaneous tissue disorders acne	16.7% 2/12 • Number of events 2 • 9 months per patient
Infections and infestations pneumonia	8.3% 1/12 • Number of events 1 • 9 months per patient

Additional Information

Director of Clinical Research Dermatology

Columbia University Dept of Dermatology

Phone: 2123056953

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place