Trial Outcomes & Findings for Tofacitnib for the Treatment of Alopecia Areata and Variants (NCT NCT02197455)

NCT ID: NCT02197455

Last Updated: 2017-04-04

Results Overview

SALT score range is from 0 (no hair loss) to 100 (100% hair loss)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2017-04-04

Participant Flow

Participant milestones

Measure	Tofacitinib Administration 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tofacitnib for the Treatment of Alopecia Areata and Variants

Baseline characteristics by cohort

Measure	Tofacitinib Administration n=30 Participants 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Age, Continuous	37.9 years STANDARD_DEVIATION 15.12 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

SALT score range is from 0 (no hair loss) to 100 (100% hair loss)

Outcome measures

Measure	Tofacitinib Administration n=30 Participants 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Mean Change in Severity of Alopecia Tool (SALT) Score	22.8 percent change in SALT score Standard Deviation 30.3

SECONDARY outcome

Timeframe: 3 months

Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition

Outcome measures

Measure	Tofacitinib Administration n=30 Participants 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Mean Change in Skindex 16 Scores	-20.3 units on a scale Interval -61.6 to 7.3

Adverse Events

Tofacitinib Administration

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tofacitinib Administration n=30 participants at risk 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Infections and infestations cold	10.0% 3/30
Infections and infestations sinus infection	6.7% 2/30
Nervous system disorders headache	10.0% 3/30
Gastrointestinal disorders abdominal pain	6.7% 2/30
Skin and subcutaneous tissue disorders acne	13.3% 4/30
General disorders fatigue	6.7% 2/30
Skin and subcutaneous tissue disorders night sweats	6.7% 2/30

Additional Information

Brett King, MD

Yale Univ School of Medicine

Phone: 2037854092

Email: brett.king@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place