A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris

Phase 3

Completed

Conditions: Acne Vulgaris

Interventions: Drug: Sarecycline

Registration Number: NCT02413346

Lead Sponsor: Almirall, S.A.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 490

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo/Sarecycline	Sarecycline	Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 milligram(mg)/kilogram(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).
Sarecycline/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).

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (55): Actavis Investigational Study Site #212
🇺🇸
West Jordan, Utah, United States
Actavis Investigational Study Site #129
🇺🇸
Encino, California, United States
Actavis Investigational Study Site #113
🇺🇸
South Bend, Indiana, United States
Actavis Investigational Study Site #230
🇺🇸
Stony Brook, New York, United States
Actavis Investigational Study Site #251
🇺🇸
Clarkston, Michigan, United States
Actavis Investigational Study Site #151
🇺🇸
Orange, Florida, United States
Actavis Investigational Study Site #206
🇺🇸
Mobile, Alabama, United States
Actavis Investigational Study Site #104
🇺🇸
Dallas, Texas, United States
Actavis Investigational Study Site #106
🇺🇸
Chicago, Illinois, United States
Actavis Investigational Study Site #124
🇺🇸
Boise, Idaho, United States
Actavis Investigational Study Site #223
🇺🇸
Pflugerville, Texas, United States
Actavis Investigational Study Site #226
🇺🇸
Clearwater, Florida, United States
Actavis Investigational Study Site #128
🇺🇸
Knoxville, Tennessee, United States
Actavis Investigational Study Site #208
🇺🇸
New York, New York, United States
Actavis Investigational Study Site #142
🇺🇸
Houston, Texas, United States
Actavis Investigational Study Site #229
🇺🇸
Raleigh, North Carolina, United States
Actavis Investigational Study Site #240
🇺🇸
Rochester, New York, United States
Actavis Investigational Study Site #216
🇺🇸
Knoxville, Tennessee, United States
Actavis Investigational Study Site #220
🇺🇸
College Station, Texas, United States
Actavis Investigational Study Site #252
🇺🇸
Arlington, Texas, United States
Actavis Investigational Study Site #257
🇺🇸
Philadelphia, Pennsylvania, United States
Actavis Investigational Study Site #211
🇺🇸
Miramar, Florida, United States
Actavis Investigation Study Site # 140
🇺🇸
North Miami Beach, Florida, United States
Actavis Investigational Study Site #242
🇺🇸
Snellville, Georgia, United States
Actavis Investigational Study Site #217
🇺🇸
Rockville, Maryland, United States
Actavis Investigational Study Site #150
🇺🇸
San Diego, California, United States
Actavis Investigational Study Site #125
🇺🇸
San Diego, California, United States
Actavis Investigational Study Site #204
🇺🇸
San Diego, California, United States
Actavis Investigational Study Site #207
🇺🇸
San Antonio, Texas, United States
Actavis Investigational Study Site #148
🇺🇸
Wheat Ridge, Colorado, United States
Actavis Investigational Study Site #231
🇺🇸
Omaha, Nebraska, United States
Actavis Investigational Study Site #222
🇺🇸
Denver, Colorado, United States
Actavis Investigational Study Site #238
🇺🇸
Jupiter, Florida, United States
Actavis Investigational Study Site #105
🇺🇸
Houston, Texas, United States
Actavis Investigational Study Site #201
🇺🇸
Katy, Texas, United States
Actavis Investigational Study Site #236
🇺🇸
Hot Springs, Arkansas, United States
Actavis Investigational Study Site #245
🇺🇸
Carlsbad, California, United States
Actavis Investigational Study Site #209
🇺🇸
Fremont, California, United States
Actavis Investigational Study Site #249
🇺🇸
Miami, Florida, United States
Actavis Investigational Study Site #145
🇺🇸
Miami, Florida, United States
Actavis Investigational Study Site #203
🇺🇸
Tampa, Florida, United States
Actavis Investigational Study Site #111
🇺🇸
Warren, Michigan, United States
Actavis Investigational Study Site #221
🇺🇸
Fridley, Minnesota, United States
Actavis Investigational Study Site #146
🇺🇸
New York, New York, United States
Actavis Investigational Study Site #225
🇺🇸
Goodlettsville, Tennessee, United States
Actavis Investigational Study Site #101
🇺🇸
Plano, Texas, United States
Actavis Investigational Study Site #244
🇺🇸
Norfolk, Virginia, United States
Actavis Investigational Study Site #144
🇺🇸
Spokane, Washington, United States
Actavis Investigational Study Site #233
🇺🇸
Walla Walla, Washington, United States
Actavis Investigational Study Site #109
🇺🇸
Nashville, Tennessee, United States
Actavis Investigational Study Site #235
🇺🇸
Clinton Township, Michigan, United States
Actavis Investigational Study Site #227
🇺🇸
Fort Gratiot, Michigan, United States
Actavis Investigational Study Site #149
🇺🇸
Gresham, Oregon, United States
Actavis Investigational Study Site #147
🇺🇸
Sacramento, California, United States
Actavis Investigational Study Site #213
🇺🇸
Louisville, Kentucky, United States