Trial Outcomes & Findings for A Study of Secukinumab for the Treatment of Alopecia Areata (NCT NCT02599129)

NCT ID: NCT02599129

Last Updated: 2021-03-11

Results Overview

Number of subjects achieving a Severity of Alopecia Tool (SALT) score of 50 at Week 24

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: Week 24
• Results posted on: 2021-03-11

Participant Flow

Subjects were enrolled from November 2015 to March 2016.

Participant milestones

Measure	Secukinumab Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.	Placebo Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
Overall Study STARTED	7	4
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Measure	Secukinumab Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.	Placebo Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
Overall Study Lack of Efficacy	2	2
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

A Study of Secukinumab for the Treatment of Alopecia Areata

Baseline characteristics by cohort

Measure	Secukinumab n=7 Participants Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.	Placebo n=4 Participants Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.	Total n=11 Participants Total of all reporting groups
Age, Continuous	31.9 years STANDARD_DEVIATION 14.3 • n=5 Participants	52.2 years STANDARD_DEVIATION 11.3 • n=7 Participants	39.3 years STANDARD_DEVIATION 16.3 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Severity of Alopecial Tool (SALT) Score SALT Score	82.5 percent hair loss STANDARD_DEVIATION 19.3 • n=5 Participants	95.3 percent hair loss STANDARD_DEVIATION 7.9 • n=7 Participants	87.1 percent hair loss STANDARD_DEVIATION 8.6 • n=5 Participants
Severity of Alopecial Tool (SALT) Score Left profile of scalp	83.6 percent hair loss STANDARD_DEVIATION 16.5 • n=5 Participants	95.0 percent hair loss STANDARD_DEVIATION 10.0 • n=7 Participants	87.7 percent hair loss STANDARD_DEVIATION 15.1 • n=5 Participants
Severity of Alopecial Tool (SALT) Score Right profile of scalp	87.9 percent hair loss STANDARD_DEVIATION 12.9 • n=5 Participants	95.0 percent hair loss STANDARD_DEVIATION 10.0 • n=7 Participants	90.5 percent hair loss STANDARD_DEVIATION 11.9 • n=5 Participants
Severity of Alopecial Tool (SALT) Score Posterior profile of scalp	84.3 percent hair loss STANDARD_DEVIATION 22.1 • n=5 Participants	90.0 percent hair loss STANDARD_DEVIATION 14.1 • n=7 Participants	86.4 percent hair loss STANDARD_DEVIATION 19.0 • n=5 Participants
Severity of Alopecial Tool (SALT) Score Vertex (Top) profile of scalp	78.4 percent hair loss STANDARD_DEVIATION 27.2 • n=5 Participants	98.75 percent hair loss STANDARD_DEVIATION 2.5 • n=7 Participants	85.8 percent hair loss STANDARD_DEVIATION 23.5 • n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Number of subjects achieving a Severity of Alopecia Tool (SALT) score of 50 at Week 24

Outcome measures

Measure	Secukinumab n=2 Participants Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.	Placebo n=1 Participants Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
Number of Subjects Achieving Severity of Alopecia Tool (SALT) Score of 50	0 Participants	0 Participants

SECONDARY outcome

Timeframe: week 24

We assessed the Number of subjects that achieved a SALT score of 90 at week 24

Outcome measures

Measure	Secukinumab n=2 Participants Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.	Placebo n=1 Participants Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
Number of Subjects Achieving a SALT Score of 90 at Week 24	0 Participants	0 Participants

SECONDARY outcome

Timeframe: week 28

We assessed the Number of subjects that achieved a SALT score of 90 at Week 28

Outcome measures

Measure	Secukinumab n=2 Participants Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.	Placebo n=1 Participants Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
Number of Subjects Achieving a SALT Score of 90 at Week 28	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 24

Number of subjects achieving a Physician's Global Assessment (PGA) score of 3 or above at week 24 (0, no regrowth; 1, <25% of regrowth; 2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% of re- growth; 5, 100% of regrowth).

Outcome measures

Measure	Secukinumab n=2 Participants Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.	Placebo n=1 Participants Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
Number of Subjects Acheiving Physician's Global Assessment (PGA) Score of 3 or Above	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 24

Number of subjects achieving a DLQI (Dermatology Life Quality Index), patient global assessment score of 3 or above at week 24 (0, no regrowth; 1, <25% of regrowth; 2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% of re- growth; 5, 100% of regrowth).

Outcome measures

Measure	Secukinumab n=2 Participants Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.	Placebo n=1 Participants Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
Number of Subjects With Dermatology Life Quality Index (DLQI) of 3 or Above	0 Participants	0 Participants

Adverse Events

Secukinumab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Secukinumab n=7 participants at risk Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.	Placebo n=4 participants at risk Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
Surgical and medical procedures Wisdom Tooth Extraction	14.3% 1/7 • Number of events 1	0.00% 0/4
Skin and subcutaneous tissue disorders Plaque Psoriasis	0.00% 0/7	25.0% 1/4 • Number of events 1

Additional Information

Dr. Mark Lebwohl

Icahn School of Medicine at Mount Sinai

Phone: 2122413288

Email: giselle.singer@mssm.edu

Results disclosure agreements

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