Alopecia Areata
Conditions
Keywords
Alopecia areata
Brief summary
Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can fall out on the scalp or elsewhere on the face and body. Alopecia areata is an autoimmune skin disease, which means that the immune system is recognizing the hair follicles as foreign and attacking them, causing round patches of hair loss. It can progress to total scalp hair loss (alopecia totalis) or complete body hair loss (alopecia universalis). The scalp is the most commonly affected area, but the beard or any hair-bearing site can be affected alone or together with the scalp. Alopecia areata occurs in males and females of all ages, and is a highly unpredictable condition that tends to recur. Alopecia areata can cause significant distress to both patients and their families. Aim: To assess the effects of a new treatment called secukinumab in patients with alopecia areata. A total of 30 patients will be included in the study, which will run for a total of 28 weeks.
Interventions
DRUGSecukinumab
subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
DRUGPlacebo
subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
Sponsors
Novartis
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subject at least 18 years of age * If female, the subject is not pregnant or nursing * Subject is able to provide written informed consent and comply with the requirements of this study protocol. * Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 30 days before Day 0 and at least 6 months after the last study drug administration. Acceptable methods of birth control include intrauterine device (IUD); oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence and barrier methods with spermicide. Otherwise, if not of childbearing potential, subjects must: have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year. * Subject with AA (unequivocal cases of AA), affecting at least 60% of the scalp, and present for at least 6 months. * Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) negative at the time of screening, or if patient has a history of positive PPD or QuantiFERON, he/she has completed the appropriate prophylaxis. * Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, and physical examination.
Exclusion criteria
* Other concomitant types of alopecia (androgenetic, female pattern, traction, scarring and others) * Any subject who is pregnant or refuses to practice an acceptable method of birth control (as stated in inclusion criterion # 4) * History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) at screening. Subjects with a positive or indeterminate PPD or QFT test may participate in the study if a full tuberculosis work up (according to local practice/guidelines) is completed within 12 weeks prior to randomization and establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated at least for 4 weeks prior to randomization and the course of prophylaxis is planned to be completed. * Active Crohn's disease * Known hypersensitivity to latex * Subjects with a history of HIV, or history of positive HCV or HBV * Previous exposure to Secukinumab or other drug targeting IL-17A or its receptor; use of sensitizing therapy for alopecia areata including DPCP, squaric acid, DNCB within 1 month; PUVA, or any form of phototherapy within 1 month; use of any immunosuppressive therapies (systemic corticosteroids, methotrexate, azathioprine, mycophenolate mofetil, cyclosporine) within 1 month; or use of topical therapies (two weeks). All the above therapies will not be allowed during this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Achieving Severity of Alopecia Tool (SALT) Score of 50 | Week 24 | Number of subjects achieving a Severity of Alopecia Tool (SALT) score of 50 at Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Achieving a SALT Score of 90 at Week 28 | week 28 | We assessed the Number of subjects that achieved a SALT score of 90 at Week 28 |
| Number of Subjects Achieving a SALT Score of 90 at Week 24 | week 24 | We assessed the Number of subjects that achieved a SALT score of 90 at week 24 |
| Number of Subjects Acheiving Physician's Global Assessment (PGA) Score of 3 or Above | 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). |
| Number of Subjects With Dermatology Life Quality Index (DLQI) of 3 or Above | 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). |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled from November 2015 to March 2016.
Participants by arm
| Arm | Count |
|---|---|
| Secukinumab Secukinumab: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20. | 7 |
| Placebo Placebo: subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20. | 4 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 2 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Secukinumab | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 31.9 years STANDARD_DEVIATION 14.3 | 39.3 years STANDARD_DEVIATION 16.3 | 52.2 years STANDARD_DEVIATION 11.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 8 Participants | 3 Participants |
| Severity of Alopecial Tool (SALT) Score Left profile of scalp | 83.6 percent hair loss STANDARD_DEVIATION 16.5 | 87.7 percent hair loss STANDARD_DEVIATION 15.1 | 95.0 percent hair loss STANDARD_DEVIATION 10 |
| Severity of Alopecial Tool (SALT) Score Posterior profile of scalp | 84.3 percent hair loss STANDARD_DEVIATION 22.1 | 86.4 percent hair loss STANDARD_DEVIATION 19 | 90.0 percent hair loss STANDARD_DEVIATION 14.1 |
| Severity of Alopecial Tool (SALT) Score Right profile of scalp | 87.9 percent hair loss STANDARD_DEVIATION 12.9 | 90.5 percent hair loss STANDARD_DEVIATION 11.9 | 95.0 percent hair loss STANDARD_DEVIATION 10 |
| Severity of Alopecial Tool (SALT) Score SALT Score | 82.5 percent hair loss STANDARD_DEVIATION 19.3 | 87.1 percent hair loss STANDARD_DEVIATION 8.6 | 95.3 percent hair loss STANDARD_DEVIATION 7.9 |
| Severity of Alopecial Tool (SALT) Score Vertex (Top) profile of scalp | 78.4 percent hair loss STANDARD_DEVIATION 27.2 | 85.8 percent hair loss STANDARD_DEVIATION 23.5 | 98.75 percent hair loss STANDARD_DEVIATION 2.5 |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 4 |
| other Total, other adverse events | 1 / 7 | 1 / 4 |
| serious Total, serious adverse events | 0 / 7 | 0 / 4 |
Outcome results
Primary
Number of Subjects Achieving Severity of Alopecia Tool (SALT) Score of 50
Number of subjects achieving a Severity of Alopecia Tool (SALT) score of 50 at Week 24
Time frame: Week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab | Number of Subjects Achieving Severity of Alopecia Tool (SALT) Score of 50 | 0 Participants |
| Placebo | Number of Subjects Achieving Severity of Alopecia Tool (SALT) Score of 50 | 0 Participants |
Secondary
Number of Subjects Acheiving Physician's Global Assessment (PGA) Score of 3 or Above
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).
Time frame: Week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab | Number of Subjects Acheiving Physician's Global Assessment (PGA) Score of 3 or Above | 0 Participants |
| Placebo | Number of Subjects Acheiving Physician's Global Assessment (PGA) Score of 3 or Above | 0 Participants |
Secondary
Number of Subjects Achieving a SALT Score of 90 at Week 24
We assessed the Number of subjects that achieved a SALT score of 90 at week 24
Time frame: week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab | Number of Subjects Achieving a SALT Score of 90 at Week 24 | 0 Participants |
| Placebo | Number of Subjects Achieving a SALT Score of 90 at Week 24 | 0 Participants |
Secondary
Number of Subjects Achieving a SALT Score of 90 at Week 28
We assessed the Number of subjects that achieved a SALT score of 90 at Week 28
Time frame: week 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab | Number of Subjects Achieving a SALT Score of 90 at Week 28 | 0 Participants |
| Placebo | Number of Subjects Achieving a SALT Score of 90 at Week 28 | 0 Participants |
Secondary
Number of Subjects With Dermatology Life Quality Index (DLQI) of 3 or Above
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).
Time frame: Week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab | Number of Subjects With Dermatology Life Quality Index (DLQI) of 3 or Above | 0 Participants |
| Placebo | Number of Subjects With Dermatology Life Quality Index (DLQI) of 3 or Above | 0 Participants |