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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Sarecycline

• Study Type: Interventional
• Enrollment (Actual): 490
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Actavis Investigational Study Site #206
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Actavis Investigational Study Site #236
  • California
    • Carlsbad, California, United States, 92008
      • Actavis Investigational Study Site #245
    • Encino, California, United States, 91436
      • Actavis Investigational Study Site #129
    • Fremont, California, United States, 94538
      • Actavis Investigational Study Site #209
    • Sacramento, California, United States, 95819
      • Actavis Investigational Study Site #147
    • San Diego, California, United States, 92120
      • Actavis Investigational Study Site #150
    • San Diego, California, United States, 92123
      • Actavis Investigational Study Site #125
    • San Diego, California, United States, 92123
      • Actavis Investigational Study Site #204
  • Colorado
    • Denver, Colorado, United States, 80220
      • Actavis Investigational Study Site #222
    • Wheat Ridge, Colorado, United States, 80033
      • Actavis Investigational Study Site #148
  • Florida
    • Clearwater, Florida, United States, 33761
      • Actavis Investigational Study Site #226
    • Jupiter, Florida, United States, 33458
      • Actavis Investigational Study Site #238
    • Miami, Florida, United States, 33142
      • Actavis Investigational Study Site #249
    • Miami, Florida, United States, 33175
      • Actavis Investigational Study Site #145
    • Miramar, Florida, United States, 33207
      • Actavis Investigational Study Site #211
    • North Miami Beach, Florida, United States, 33162
      • Actavis Investigation Study Site # 140
    • Orange, Florida, United States, 32073
      • Actavis Investigational Study Site #151
    • Tampa, Florida, United States, 33609
      • Actavis Investigational Study Site #203
  • Georgia
    • Snellville, Georgia, United States, 30078
      • Actavis Investigational Study Site #242
  • Idaho
    • Boise, Idaho, United States, 83704
      • Actavis Investigational Study Site #124
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Actavis Investigational Study Site #106
  • Indiana
    • South Bend, Indiana, United States, 46617
      • Actavis Investigational Study Site #113
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Actavis Investigational Study Site #213
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Actavis Investigational Study Site #217
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Actavis Investigational Study Site #251
    • Clinton Township, Michigan, United States, 48038
      • Actavis Investigational Study Site #235
    • Fort Gratiot, Michigan, United States, 48059
      • Actavis Investigational Study Site #227
    • Warren, Michigan, United States, 48088
      • Actavis Investigational Study Site #111
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Actavis Investigational Study Site #221
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Actavis Investigational Study Site #231
  • New York
    • New York, New York, United States, 10016
      • Actavis Investigational Study Site #146
    • New York, New York, United States, 10155
      • Actavis Investigational Study Site #208
    • Rochester, New York, United States, 14623
      • Actavis Investigational Study Site #240
    • Stony Brook, New York, United States, 11790
      • Actavis Investigational Study Site #230
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Actavis Investigational Study Site #229
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Actavis Investigational Study Site #149
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Actavis Investigational Study Site #257
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Actavis Investigational Study Site #225
    • Knoxville, Tennessee, United States, 37917
      • Actavis Investigational Study Site #128
    • Knoxville, Tennessee, United States, 37922
      • Actavis Investigational Study Site #216
    • Nashville, Tennessee, United States, 37215
      • Actavis Investigational Study Site #109
  • Texas
    • Arlington, Texas, United States, 76011
      • Actavis Investigational Study Site #223
    • Arlington, Texas, United States, 76011
      • Actavis Investigational Study Site #252
    • College Station, Texas, United States, 77845
      • Actavis Investigational Study Site #220
    • Dallas, Texas, United States, 75234
      • Actavis Investigational Study Site #104
    • Houston, Texas, United States, 77004
      • Actavis Investigational Study Site #142
    • Houston, Texas, United States, 77056
      • Actavis Investigational Study Site #105
    • Katy, Texas, United States, 77494
      • Actavis Investigational Study Site #201
    • Pflugerville, Texas, United States, 78660
      • Actavis Investigational Study Site #223
    • Plano, Texas, United States, 75093
      • Actavis Investigational Study Site #101
    • San Antonio, Texas, United States, 78218
      • Actavis Investigational Study Site #207
  • Utah
    • West Jordan, Utah, United States, 84088
      • Actavis Investigational Study Site #212
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Actavis Investigational Study Site #244
  • Washington
    • Spokane, Washington, United States, 99202
      • Actavis Investigational Study Site #144
    • Walla Walla, Washington, United States, 99362
      • Actavis Investigational Study Site #233

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo/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).	Drug: Sarecycline; Administered based on participant's body weight.
Experimental: 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).	Drug: Sarecycline; Administered based on participant's body weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 40 Weeks

Collaborators and Investigators

• Sponsor: Almirall, S.A.
• Collaborators: Allergan
• Investigators: Study Director: David Berk, MD, Allergan, plc

Publications and helpful links

General Publications

• Pariser DM, Green LJ, Lain EL, Schmitz C, Chinigo AS, McNamee B, Berk DR. Safety and Tolerability of Sarecycline for the Treatment of Acne Vulgaris: Results from a Phase III, Multicenter, Open-Label Study and a Phase I Phototoxicity Study. J Clin Aesthet Dermatol. 2019 Nov;12(11):E53-E62. Epub 2019 Nov 1.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2015
• Primary Completion (Actual): August 26, 2016
• Study Completion (Actual): August 26, 2016

Study Registration Dates

• First Submitted: April 2, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 9, 2015

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Infective Agents; Dermatologic Agents; Anti-Bacterial Agents; Sarecycline
• Other Study ID Numbers: SC1403