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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sarecycline
Sponsored by
Almirall, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Actavis Investigational Study Site #206
  • Actavis Investigational Study Site #236
  • Actavis Investigational Study Site #245
  • Actavis Investigational Study Site #129
  • Actavis Investigational Study Site #209
  • Actavis Investigational Study Site #147
  • Actavis Investigational Study Site #150
  • Actavis Investigational Study Site #125
  • Actavis Investigational Study Site #204
  • Actavis Investigational Study Site #222
  • Actavis Investigational Study Site #148
  • Actavis Investigational Study Site #226
  • Actavis Investigational Study Site #238
  • Actavis Investigational Study Site #249
  • Actavis Investigational Study Site #145
  • Actavis Investigational Study Site #211
  • Actavis Investigation Study Site # 140
  • Actavis Investigational Study Site #151
  • Actavis Investigational Study Site #203
  • Actavis Investigational Study Site #242
  • Actavis Investigational Study Site #124
  • Actavis Investigational Study Site #106
  • Actavis Investigational Study Site #113
  • Actavis Investigational Study Site #213
  • Actavis Investigational Study Site #217
  • Actavis Investigational Study Site #251
  • Actavis Investigational Study Site #235
  • Actavis Investigational Study Site #227
  • Actavis Investigational Study Site #111
  • Actavis Investigational Study Site #221
  • Actavis Investigational Study Site #231
  • Actavis Investigational Study Site #146
  • Actavis Investigational Study Site #208
  • Actavis Investigational Study Site #240
  • Actavis Investigational Study Site #230
  • Actavis Investigational Study Site #229
  • Actavis Investigational Study Site #149
  • Actavis Investigational Study Site #257
  • Actavis Investigational Study Site #225
  • Actavis Investigational Study Site #128
  • Actavis Investigational Study Site #216
  • Actavis Investigational Study Site #109
  • Actavis Investigational Study Site #223
  • Actavis Investigational Study Site #252
  • Actavis Investigational Study Site #220
  • Actavis Investigational Study Site #104
  • Actavis Investigational Study Site #142
  • Actavis Investigational Study Site #105
  • Actavis Investigational Study Site #201
  • Actavis Investigational Study Site #223
  • Actavis Investigational Study Site #101
  • Actavis Investigational Study Site #207
  • Actavis Investigational Study Site #212
  • Actavis Investigational Study Site #244
  • Actavis Investigational Study Site #144
  • Actavis Investigational Study Site #233

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Placebo/Sarecycline

Sarecycline/Sarecycline

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 2, 2015
Last Updated
January 31, 2019
Sponsor
Almirall, S.A.
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02413346
Brief Title
A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris
Official Title
A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 20, 2015 (Actual)
Primary Completion Date
August 26, 2016 (Actual)
Study Completion Date
August 26, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo/Sarecycline
Arm Type
Experimental
Arm Description
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).
Arm Title
Sarecycline/Sarecycline
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Sarecycline
Intervention Description
Administered based on participant's body weight.
Primary Outcome Measure Information:
Title
Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Berk, MD
Organizational Affiliation
Allergan, plc
Official's Role
Study Director
Facility Information:
Facility Name
Actavis Investigational Study Site #206
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Actavis Investigational Study Site #236
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Actavis Investigational Study Site #245
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States
Facility Name
Actavis Investigational Study Site #129
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Actavis Investigational Study Site #209
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Actavis Investigational Study Site #147
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Actavis Investigational Study Site #150
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Actavis Investigational Study Site #125
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Actavis Investigational Study Site #204
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Actavis Investigational Study Site #222
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Actavis Investigational Study Site #148
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Actavis Investigational Study Site #226
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Actavis Investigational Study Site #238
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Actavis Investigational Study Site #249
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Actavis Investigational Study Site #145
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Actavis Investigational Study Site #211
City
Miramar
State/Province
Florida
ZIP/Postal Code
33207
Country
United States
Facility Name
Actavis Investigation Study Site # 140
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Actavis Investigational Study Site #151
City
Orange
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Actavis Investigational Study Site #203
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Actavis Investigational Study Site #242
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Actavis Investigational Study Site #124
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Actavis Investigational Study Site #106
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Actavis Investigational Study Site #113
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Actavis Investigational Study Site #213
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Actavis Investigational Study Site #217
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Actavis Investigational Study Site #251
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Actavis Investigational Study Site #235
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Actavis Investigational Study Site #227
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Actavis Investigational Study Site #111
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Actavis Investigational Study Site #221
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Actavis Investigational Study Site #231
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Actavis Investigational Study Site #146
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Actavis Investigational Study Site #208
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
Actavis Investigational Study Site #240
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Actavis Investigational Study Site #230
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Actavis Investigational Study Site #229
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Actavis Investigational Study Site #149
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Actavis Investigational Study Site #257
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Actavis Investigational Study Site #225
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Actavis Investigational Study Site #128
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917
Country
United States
Facility Name
Actavis Investigational Study Site #216
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Actavis Investigational Study Site #109
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Actavis Investigational Study Site #223
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Actavis Investigational Study Site #252
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Actavis Investigational Study Site #220
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Actavis Investigational Study Site #104
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Actavis Investigational Study Site #142
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Actavis Investigational Study Site #105
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Actavis Investigational Study Site #201
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Actavis Investigational Study Site #223
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Actavis Investigational Study Site #101
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Actavis Investigational Study Site #207
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Actavis Investigational Study Site #212
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Actavis Investigational Study Site #244
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Actavis Investigational Study Site #144
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Actavis Investigational Study Site #233
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32038757
Citation
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.
Results Reference
derived

Learn more about this trial

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

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