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Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

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ClinicalTrials.gov Identifier: NCT02322866
Recruitment Status : Completed
First Posted : December 23, 2014
Results First Posted : May 7, 2018
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Almirall, S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Sarecycline
Drug: Placebo
Enrollment 1034
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Sarecycline
Hide Arm/Group Description Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks. Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks.
Period Title: Overall Study
Started 515 519
Completed 444 433
Not Completed 71 86
Reason Not Completed
Adverse Event             6             11
Withdrawal of Consent             16             25
Lost to Follow-up             36             39
Protocol Violation             1             0
Noncompliance with Treatment             3             4
Lack of Efficacy             3             1
Other Miscellaneous Reasons             6             6
Arm/Group Title Placebo Sarecycline Total
Hide Arm/Group Description Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks. Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 515 519 1034
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) Population included all randomized participants.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 515 participants 519 participants 1034 participants
≥9 and <12 years 4 7 11
≥12 and <18 years 256 227 483
≥18 years 255 285 540
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 515 participants 519 participants 1034 participants
Female
292
  56.7%
315
  60.7%
607
  58.7%
Male
223
  43.3%
204
  39.3%
427
  41.3%
1.Primary Outcome
Title Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
Hide Description Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants.
Arm/Group Title Placebo Sarecycline
Hide Arm/Group Description:
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 515 519
Least Squares Mean (Standard Error)
Unit of Measure: lesion count
-10.7  (0.5) -15.1  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sarecycline
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -4.4
Confidence Interval (2-Sided) 95%
-5.8 to -2.9
Estimation Comments sarecycline - placebo
2.Primary Outcome
Title Percentage of Participants With Investigator’s Global Assessment (IGA) Scale Success at Week 12
Hide Description The investigator assessed the participant’s inflammatory lesions on the face using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). The percentage of participants who achieved success is reported. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants.
Arm/Group Title Placebo Sarecycline
Hide Arm/Group Description:
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 515 519
Measure Type: Number
Unit of Measure: percentage of participants
15.3 22.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sarecycline
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments P-values were based on the test of general association between the response and treatment group using Cochran-Mantel-Haenszel test with pooled site as stratification factor.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Rate Difference
Estimated Value 7.30
Confidence Interval (2-Sided) 95%
2.53 to 12.07
Estimation Comments sarecycline - placebo
3.Secondary Outcome
Title Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
Hide Description Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Time Frame Baseline (Day 1) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants.
Arm/Group Title Placebo Sarecycline
Hide Arm/Group Description:
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 515 519
Least Squares Mean (Standard Error)
Unit of Measure: percent change in lesion counts
-35.4  (1.8) -49.9  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sarecycline
Comments Percent Change from Baseline to Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -14.4
Confidence Interval (2-Sided) 95%
-19.4 to -9.5
Estimation Comments sarecycline - placebo
4.Secondary Outcome
Title Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9
Hide Description Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Time Frame Baseline (Day 1) to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants.
Arm/Group Title Placebo Sarecycline
Hide Arm/Group Description:
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 515 519
Least Squares Mean (Standard Error)
Unit of Measure: percent change in lesion counts
-31.9  (1.7) -44.5  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sarecycline
Comments Percent Change from Baseline to Week 9
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -12.6
Confidence Interval (2-Sided) 95%
-17.3 to -7.9
Estimation Comments sarecycline - placebo
5.Secondary Outcome
Title Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6
Hide Description Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Time Frame Baseline (Day 1) to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants.
Arm/Group Title Placebo Sarecycline
Hide Arm/Group Description:
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 515 519
Least Squares Mean (Standard Error)
Unit of Measure: percent change in lesion counts
-27.3  (1.6) -39.1  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sarecycline
Comments Percent Change from Baseline to Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -11.8
Confidence Interval (2-Sided) 95%
-16.1 to -7.5
Estimation Comments sarecycline - placebo
6.Secondary Outcome
Title Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3
Hide Description Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Time Frame Baseline (Day 1) to Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants.
Arm/Group Title Placebo Sarecycline
Hide Arm/Group Description:
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 515 519
Least Squares Mean (Standard Error)
Unit of Measure: percent change in lesion counts
-18.6  (1.6) -28.0  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sarecycline
Comments Percent Change from Baseline to Week 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -9.4
Confidence Interval (2-Sided) 95%
-13.5 to -5.3
Estimation Comments sarecycline - placebo
7.Secondary Outcome
Title Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9
Hide Description Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Time Frame Baseline (Day 1) to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants.
Arm/Group Title Placebo Sarecycline
Hide Arm/Group Description:
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 515 519
Least Squares Mean (Standard Error)
Unit of Measure: lesion count
-9.5  (0.5) -13.4  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sarecycline
Comments Change from Baseline to Week 9
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.8
Confidence Interval (2-Sided) 95%
-5.2 to -2.5
Estimation Comments sarecycline - placebo
8.Secondary Outcome
Title Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6
Hide Description Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Time Frame Baseline (Day 1) to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants.
Arm/Group Title Placebo Sarecycline
Hide Arm/Group Description:
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 515 519
Least Squares Mean (Standard Error)
Unit of Measure: lesion count
-8.0  (0.5) -11.7  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sarecycline
Comments Change from Baseline to Week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.7
Confidence Interval (2-Sided) 95%
-5.0 to -2.4
Estimation Comments sarecycline - placebo
9.Secondary Outcome
Title Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3
Hide Description Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Time Frame Baseline (Day 1) to Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants.
Arm/Group Title Placebo Sarecycline
Hide Arm/Group Description:
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
Overall Number of Participants Analyzed 515 519
Least Squares Mean (Standard Error)
Unit of Measure: lesion count
-5.5  (0.5) -8.4  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sarecycline
Comments Change from Baseline to Week 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-4.1 to -1.7
Estimation Comments sarecycline - placebo
Time Frame Up to 157 Days
Adverse Event Reporting Description The number of participants at risk for Serious Adverse Events and Adverse Events was based on the Safety Population that included all participants who received at least 1 dose of study treatment.
 
Arm/Group Title Placebo Sarecycline
Hide Arm/Group Description Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks. Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.
All-Cause Mortality
Placebo Sarecycline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/513 (0.00%)   0/513 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Sarecycline
Affected / at Risk (%) Affected / at Risk (%)
Total   1/513 (0.19%)   4/513 (0.78%) 
Gastrointestinal disorders     
Crohn’s disease  1  0/513 (0.00%)  1/513 (0.19%) 
Infections and infestations     
Tonsillitis  1  0/513 (0.00%)  1/513 (0.19%) 
Pregnancy, puerperium and perinatal conditions     
Abortion  1  0/513 (0.00%)  1/513 (0.19%) 
Psychiatric disorders     
Depression  1  0/513 (0.00%)  1/513 (0.19%) 
Oppositional defiant disorder  1  1/513 (0.19%)  0/513 (0.00%) 
1
Term from vocabulary, MedDRA, Version 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Sarecycline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/513 (0.00%)   0/513 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT02322866     History of Changes
Other Study ID Numbers: SC1402
First Submitted: December 15, 2014
First Posted: December 23, 2014
Results First Submitted: April 3, 2018
Results First Posted: May 7, 2018
Last Update Posted: February 1, 2019