Acne Vulgaris
Conditions
Brief summary
Open-label study will evaluate the safety of an approximate 1.5 mg/kg/day dose of oral sarecycline in the long-term treatment of participants with moderate to severe facial acne vulgaris.
Interventions
DRUGSarecycline
Administered based on participant's body weight.
Sponsors
Allergan
Almirall, S.A.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successfully completed participation in Phase 3 study of sarecycline (SC1401 or SC1402) * Signed informed consent or assent form * Body weight between 33 kg and 136 kg, inclusive * Negative urine pregnancy test for females of childbearing potential * Agrees to use effective method of contraception throughout study, if applicable. * Able to fulfill protocol requirements, indicated willingness to participate in study and agrees to all study procedures by providing written informed consent/assent and authorization to disclose (personal health information)
Exclusion criteria
* Currently participating in another clinical study, unless it is a pharmacokinetic sarecycline study and participation approved by medical monitor; has received investigational medication (except sarecycline) within 30 days of enrollment. * Discontinued participation in a Phase 3 study with sarecycline for any reason * Had poor compliance wtih study requirements/study drug dosing in a Phase 3 study with sarecycline * Is receiving/planning to receive any systemic acne medication, systemic retinoids, systemic corticosteroids or any androgen/anti-androgenic therapy (eg, testosterone, spironolactone) * Is pregnant, lactating or planning a pregnancy during the study period * Has a significant intercurrent illness (including clinically significant abnormality in clinical laboratory tests), psychiatric disorder, or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study * Is judged by the Investigator to be unsuitable for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE) | Up to 40 Weeks | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. A TEAE is an AE that occurs after the first dose of study drug. |
Countries
United States
Participant flow
Recruitment details
Long-term safety study for participants who were treated for moderate to severe facial acne vulgaris in the double-blind studies SC1401 \[NCT02320149\] or SC1402 \[NCT02322866\].
Participants by arm
| Arm | Count |
|---|---|
| Placebo/Sarecycline Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks). | 236 |
| Sarecycline/Sarecycline Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks). | 247 |
| Total | 483 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 6 |
| Overall Study | Lost to Follow-up | 17 | 21 |
| Overall Study | Other Miscellaneous Reasons | 4 | 3 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 30 | 40 |
Baseline characteristics
| Characteristic | Placebo/Sarecycline | Sarecycline/Sarecycline | Total |
|---|---|---|---|
| Age, Customized ≥12 and <18 years | 138 participants | 152 participants | 290 participants |
| Age, Customized ≥18 years | 96 participants | 92 participants | 188 participants |
| Age, Customized ≥9 and <12 years | 2 participants | 3 participants | 5 participants |
| Sex: Female, Male Female | 122 Participants | 125 Participants | 247 Participants |
| Sex: Female, Male Male | 114 Participants | 122 Participants | 236 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 236 | 0 / 247 |
| other Total, other adverse events | 13 / 236 | 5 / 247 |
| serious Total, serious adverse events | 2 / 236 | 2 / 247 |
Outcome results
Primary
Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. A TEAE is an AE that occurs after the first dose of study drug.
Time frame: Up to 40 Weeks
Population: Safety Population included all participants among the screened population who were exposed to study treatment (sarecycline) in either the double-blind lead-in study or this open-label extension study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo/Sarecycline | Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE) | 94 participants |
| Sarecycline/Sarecycline | Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE) | 94 participants |