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

NCT02413346 | Completed Phase 3 Results

• 1 other identifier: SC1403
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 56

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo/Sarecycline

EXPERIMENTAL

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

Sarecycline/Sarecycline

EXPERIMENTAL

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

Interventions

Sarecycline DRUG

Administered based on participant's body weight.

Placebo/Sarecycline; Sarecycline/Sarecycline

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Almirall, S.A.: lead
• Allergan: collaborator

Study Sites (56)

Actavis Investigational Study Site #206

Mobile, Alabama, 36608, United States

Location

Actavis Investigational Study Site #236

Hot Springs, Arkansas, 71913, United States

Location

Actavis Investigational Study Site #245

Carlsbad, California, 92008, United States

Location

Actavis Investigational Study Site #129

Encino, California, 91436, United States

Location

Actavis Investigational Study Site #209

Fremont, California, 94538, United States

Location

Actavis Investigational Study Site #147

Sacramento, California, 95819, United States

Location

Actavis Investigational Study Site #150

San Diego, California, 92120, United States

Location

Actavis Investigational Study Site #125

San Diego, California, 92123, United States

Location

Actavis Investigational Study Site #204

San Diego, California, 92123, United States

Location

Actavis Investigational Study Site #222

Denver, Colorado, 80220, United States

Location

Actavis Investigational Study Site #148

Wheat Ridge, Colorado, 80033, United States

Location

Actavis Investigational Study Site #226

Clearwater, Florida, 33761, United States

Location

Actavis Investigational Study Site #238

Jupiter, Florida, 33458, United States

Location

Actavis Investigational Study Site #249

Miami, Florida, 33142, United States

Location

Actavis Investigational Study Site #145

Miami, Florida, 33175, United States

Location

Actavis Investigational Study Site #211

Miramar, Florida, 33207, United States

Location

Actavis Investigation Study Site # 140

North Miami Beach, Florida, 33162, United States

Location

Actavis Investigational Study Site #151

Orange, Florida, 32073, United States

Location

Actavis Investigational Study Site #203

Tampa, Florida, 33609, United States

Location

Actavis Investigational Study Site #242

Snellville, Georgia, 30078, United States

Location

Actavis Investigational Study Site #124

Boise, Idaho, 83704, United States

Location

Actavis Investigational Study Site #106

Chicago, Illinois, 60611, United States

Location

Actavis Investigational Study Site #113

South Bend, Indiana, 46617, United States

Location

Actavis Investigational Study Site #213

Louisville, Kentucky, 40202, United States

Location

Actavis Investigational Study Site #217

Rockville, Maryland, 20850, United States

Location

Actavis Investigational Study Site #251

Clarkston, Michigan, 48346, United States

Location

Actavis Investigational Study Site #235

Clinton Township, Michigan, 48038, United States

Location

Actavis Investigational Study Site #227

Fort Gratiot, Michigan, 48059, United States

Location

Actavis Investigational Study Site #111

Warren, Michigan, 48088, United States

Location

Actavis Investigational Study Site #221

Fridley, Minnesota, 55432, United States

Location

Actavis Investigational Study Site #231

Omaha, Nebraska, 68144, United States

Location

Actavis Investigational Study Site #146

New York, New York, 10016, United States

Location

Actavis Investigational Study Site #208

New York, New York, 10155, United States

Location

Actavis Investigational Study Site #240

Rochester, New York, 14623, United States

Location

Actavis Investigational Study Site #230

Stony Brook, New York, 11790, United States

Location

Actavis Investigational Study Site #229

Raleigh, North Carolina, 27612, United States

Location

Actavis Investigational Study Site #149

Gresham, Oregon, 97030, United States

Location

Actavis Investigational Study Site #257

Philadelphia, Pennsylvania, 19103, United States

Location

Actavis Investigational Study Site #225

Goodlettsville, Tennessee, 37072, United States

Location

Actavis Investigational Study Site #128

Knoxville, Tennessee, 37917, United States

Location

Actavis Investigational Study Site #216

Knoxville, Tennessee, 37922, United States

Location

Actavis Investigational Study Site #109

Nashville, Tennessee, 37215, United States

Location

Actavis Investigational Study Site #223

Arlington, Texas, 76011, United States

Location

Actavis Investigational Study Site #252

Arlington, Texas, 76011, United States

Location

Actavis Investigational Study Site #220

College Station, Texas, 77845, United States

Location

Actavis Investigational Study Site #104

Dallas, Texas, 75234, United States

Location

Actavis Investigational Study Site #142

Houston, Texas, 77004, United States

Location

Actavis Investigational Study Site #105

Houston, Texas, 77056, United States

Location

Actavis Investigational Study Site #201

Katy, Texas, 77494, United States

Location

Actavis Investigational Study Site #223

Pflugerville, Texas, 78660, United States

Location

Actavis Investigational Study Site #101

Plano, Texas, 75093, United States

Location

Actavis Investigational Study Site #207

San Antonio, Texas, 78218, United States

Location

Actavis Investigational Study Site #212

West Jordan, Utah, 84088, United States

Location

Actavis Investigational Study Site #244

Norfolk, Virginia, 23507, United States

Location

Actavis Investigational Study Site #144

Spokane, Washington, 99202, United States

Location

Actavis Investigational Study Site #233

Walla Walla, Washington, 99362, United States

Location

Related Publications (1)

• 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.

  PMID: 32038757 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

sarecycline

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• David Berk, MD

  Allergan, plc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 9, 2015
• Study Start: March 20, 2015
• Primary Completion: August 26, 2016
• Study Completion: August 26, 2016
• Last Updated: February 1, 2019
• Results First Posted: May 4, 2018

Record last verified: 2019-01

Locations

US (56)