Alopecia Areata
Conditions
Brief summary
The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, severe alopecia areata. Patients from European sites who previously completed a qualifying CTP-543 clinical trial may participate in this study.
Interventions
DRUGCTP-543
Twice daily dosing
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial
Exclusion criteria
* Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis * Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication * Donation of blood at any point throughout the study and for 30 days after last dose of study medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety | 108 weeks | — |
| Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108 | 108 weeks | SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). This outcome measures the relative Change from Pre-zero Baseline in Total SALT Scores. Relative change from baseline was defined as 100\*(post-baseline value - baseline)/baseline. |
Countries
France, Germany, Hungary, Poland, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CTP-543 8 mg BID Participants received CTP-543 8 mg tablets, orally, twice a day | 255 |
| CTP-543 12 mg BID Participants received CTP-543 12 mg tablets, orally, twice a day | 152 |
| Total | 407 |
Baseline characteristics
| Characteristic | CTP-543 12 mg BID | Total | CTP-543 8 mg BID |
|---|---|---|---|
| Age, Continuous | 38.2 years STANDARD_DEVIATION 12.86 | 38.7 years STANDARD_DEVIATION 12.57 | 38.9 years STANDARD_DEVIATION 12.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 12 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 117 Participants | 303 Participants | 186 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 30 Participants | 92 Participants | 62 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 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 | 30 Participants | 92 Participants | 62 Participants |
| Race (NIH/OMB) White | 121 Participants | 314 Participants | 193 Participants |
| Sex: Female, Male Female | 89 Participants | 270 Participants | 181 Participants |
| Sex: Female, Male Male | 63 Participants | 137 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 367 | 0 / 273 |
| other Total, other adverse events | 176 / 367 | 127 / 273 |
| serious Total, serious adverse events | 16 / 367 | 5 / 273 |
Outcome results
Primary
Number of Participants With Adverse Events as a Measure of Safety
Time frame: 108 weeks
Population: All subjects who received at least 1 dose of CTP-543 in this study. Subjects could be counted in both CTP-543 dose groups due to dose changes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTP-543 8 mg BID | Number of Participants With Adverse Events as a Measure of Safety | 308 Participants |
| CTP-543 12 mg BID | Number of Participants With Adverse Events as a Measure of Safety | 224 Participants |
Primary
Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). This outcome measures the relative Change from Pre-zero Baseline in Total SALT Scores. Relative change from baseline was defined as 100\*(post-baseline value - baseline)/baseline.
Time frame: 108 weeks
Population: Subjects received ≥1 dose of CTP-543 and ≥1 post-baseline SALT score. The 12 mg BID dose was removed per amended protocol; those on it were reduced to 8 mg BID and are shown in the (12→8 mg BID) group. Max 12 mg BID exposure was 81 weeks; by week 108, no subjects remained on it. Participant Flow reflects planned groups based on prior dose (active) or randomization (placebo). Analysis is based on initial treatment, then first new dose if changed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CTP-543 8 mg BID | Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108 | -96.38 Percentage change | Standard Deviation 8.79 |
| CTP-543 12 mg BID | Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108 | -88.57 Percentage change | Standard Deviation 18.715 |
| CTP-543 12 mg BID to CTP-543 8 mg BID | Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108 | -90.25 Percentage change | Standard Deviation 18.86 |