Trial Outcomes & Findings for Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne (NCT NCT02320149)

NCT ID: NCT02320149

Last Updated: 2019-02-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 968 participants
• Primary outcome timeframe: Baseline (Day 1) to Week 12
• Results posted on: 2019-02-15

Participant Flow

Participant milestones

Measure	Sarecycline Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Study STARTED	483	485
Overall Study COMPLETED	420	405
Overall Study NOT COMPLETED	63	80

Reasons for withdrawal

Measure	Sarecycline Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Overall Study Adverse Event	3	7
Overall Study Withdrawal of Consent	28	32
Overall Study Lost to Follow-up	21	34
Overall Study Protocol Violation	2	1
Overall Study Noncompliance with Study Treatment	7	2
Overall Study Lack of Efficacy	0	1
Overall Study Other Miscellaneous Reasons	2	3

Baseline Characteristics

Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

Baseline characteristics by cohort

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.	Total n=968 Participants Total of all reporting groups
Age, Customized ≥9 and <12 Years	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
Age, Customized ≥12 and <18 Years	241 participants n=5 Participants	235 participants n=7 Participants	476 participants n=5 Participants
Age, Customized ≥18 Years	238 participants n=5 Participants	244 participants n=7 Participants	482 participants n=5 Participants
Sex: Female, Male Female	268 Participants n=5 Participants	271 Participants n=7 Participants	539 Participants n=5 Participants
Sex: Female, Male Male	215 Participants n=5 Participants	214 Participants n=7 Participants	429 Participants n=5 Participants
Race/Ethnicity, Customized White	377 Participants n=5 Participants	377 Participants n=7 Participants	754 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	80 Participants n=5 Participants	79 Participants n=7 Participants	159 Participants n=5 Participants
Race/Ethnicity, Customized Asian	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Multiple races	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	144 Participants n=5 Participants	143 Participants n=7 Participants	287 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	339 Participants n=5 Participants	342 Participants n=7 Participants	681 Participants n=5 Participants
Inflammatory Lesion Counts	29.7 lesion count STANDARD_DEVIATION 8.7 • n=5 Participants	30.2 lesion count STANDARD_DEVIATION 9.6 • n=7 Participants	30.0 lesion count STANDARD_DEVIATION 9.2 • n=5 Participants
Investigator's Global Assessment (IGA) Score - Face	3.1 score on a scale STANDARD_DEVIATION 0.4 • n=5 Participants	3.2 score on a scale STANDARD_DEVIATION 0.4 • n=7 Participants	3.1 score on a scale STANDARD_DEVIATION 0.4 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to Week 12

Population: ITT population included all randomized participants.

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.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Absolute Change in Facial Inflammatory Lesion Counts at Week 12	-15.3 lesion count Standard Error 0.6	-10.1 lesion count Standard Error 0.6

PRIMARY outcome

Timeframe: Baseline (Day 1) to Week 12

Population: ITT population included all randomized participants.

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.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12	21.9 percentage of participants	10.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 12

Population: ITT population included all randomized participants.

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 ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12	-51.8 percent change in lesion count Standard Error 1.9	-35.1 percent change in lesion count Standard Error 2.0

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 9

Population: ITT population included all randomized participants.

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 ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9	-47.4 percent change in lesion count Standard Error 1.7	-34.9 percent change in lesion count Standard Error 1.7

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 6

Population: ITT population included all randomized participants.

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 ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6	-42.2 percent change in lesion count Standard Error 1.6	-28.9 percent change in lesion count Standard Error 1.6

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 3

Population: ITT population included all randomized participants.

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 ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3	-29.6 percent change in lesion count Standard Error 1.5	-22.4 percent change in lesion count Standard Error 1.5

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 9

Population: ITT population included all randomized participants.

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 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 ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9	-13.9 lesion count Standard Error 0.5	-10.0 lesion count Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline (Day 1) to Weeks 6

Population: ITT population included all randomized participants.

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 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 ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6	-12.5 lesion count Standard Error 0.5	-8.4 lesion count Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 3

Population: ITT population included all randomized participants.

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 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 ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3	-8.5 lesion count Standard Error 0.4	-6.4 lesion count Standard Error 0.4

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 12

Population: ITT population included all randomized participants.

Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12	-27.0 percent change in lesion count Standard Error 5.6	-22.7 percent change in lesion count Standard Error 5.6

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 9

Population: ITT population included all randomized participants.

Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9	-20.8 percent change in lesion count Standard Error 5.3	-18.0 percent change in lesion count Standard Error 5.3

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 6

Population: ITT population included all randomized participants.

Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6	-14.6 percent change in lesion count Standard Error 6.6	-17.6 percent change in lesion count Standard Error 6.6

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 3

Population: ITT population included all randomized participants.

Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3	-8.0 percent change in lesion count Standard Error 4.4	-14.3 percent change in lesion count Standard Error 4.3

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 12

Population: ITT population included all randomized participants.

Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12	-15.1 lesion count Standard Error 0.9	-11.2 lesion count Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 9

Population: ITT population included all randomized participants.

Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9	-13.0 lesion count Standard Error 0.8	-9.6 lesion count Standard Error 0.8

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 6

Population: ITT population included all randomized participants.

Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6	-10.6 lesion count Standard Error 0.7	-8.6 lesion count Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 3

Population: ITT population included all randomized participants.

Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.

Outcome measures

Measure	Sarecycline n=483 Participants Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=485 Participants Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3	-7.9 lesion count Standard Error 0.6	-7.1 lesion count Standard Error 0.6

Adverse Events

Sarecycline

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sarecycline n=481 participants at risk Sarecycline tablets, 1.5 mg/kg/day, taken orally once daily for 12 weeks.	Placebo n=483 participants at risk Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Infections and infestations Appendicitis	0.00% 0/481 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.	0.21% 1/483 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.
Infections and infestations Cellulitis	0.00% 0/481 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.	0.21% 1/483 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.
Investigations Alanine aminotransferase increased	0.21% 1/481 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.	0.00% 0/483 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.
Investigations Aspartate aminotransferase increased	0.21% 1/481 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.	0.00% 0/483 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.
Investigations Gamma-glutamyltransferase increased	0.21% 1/481 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.	0.00% 0/483 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.21% 1/481 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.	0.00% 0/483 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/481 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.	0.41% 2/483 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.
Psychiatric disorders Suicide attempt	0.00% 0/481 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.	0.21% 1/483 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.
Renal and urinary disorders Nephrolithiasis	0.21% 1/481 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.	0.00% 0/483 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.
Social circumstances Miscarriage of partner	0.00% 0/481 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.	0.21% 1/483 • Up to 20.7 Weeks The number of participants at risk for Serious Adverse Events and Adverse Events were based on the Safety Population that included all participants who received at least one dose of study treatment. Two participants in the sarecycline arm and two in the placebo arm did not receive study treatment.

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER