Trial Outcomes & Findings for A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris (NCT NCT02413346)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

490 participants

Primary outcome timeframe

Up to 40 Weeks

Results posted on

2019-02-01

Participant Flow

Long-term safety study for participants who were treated for moderate to severe facial acne vulgaris in the double-blind studies SC1401 \[NCT02320149\] or SC1402 \[NCT02322866\].

Participant milestones

Participant milestones
Measure	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).	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).
Overall Study STARTED	236	247
Overall Study COMPLETED	177	177
Overall Study NOT COMPLETED	59	70

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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).
Overall Study Adverse Event	6	6
Overall Study Withdrawal by Subject	30	40
Overall Study Lost to Follow-up	17	21
Overall Study Protocol Violation	2	0
Overall Study Other Miscellaneous Reasons	4	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo/Sarecycline n=236 Participants Participants received placebo-matching 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).	Sarecycline/Sarecycline n=247 Participants 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).	Total n=483 Participants Total of all reporting groups
Age, Customized ≥9 and <12 years	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Age, Customized ≥12 and <18 years	138 participants n=5 Participants	152 participants n=7 Participants	290 participants n=5 Participants
Age, Customized ≥18 years	96 participants n=5 Participants	92 participants n=7 Participants	188 participants n=5 Participants
Sex: Female, Male Female	122 Participants n=5 Participants	125 Participants n=7 Participants	247 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants	122 Participants n=7 Participants	236 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 40 Weeks

Population: Safety Population included all participants among the screened population who were exposed to study treatment (sarecycline) in either the double-blind lead-in study or this open-label extension study.

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.

Outcome measures

Outcome measures
Measure	Placebo/Sarecycline n=236 Participants Participants received placebo-matching 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).	Sarecycline/Sarecycline n=247 Participants 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).
Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)	94 participants	94 participants

Adverse Events

Placebo/Sarecycline

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Sarecycline/Sarecycline

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo/Sarecycline n=236 participants at risk Participants received placebo-matching 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).	Sarecycline/Sarecycline n=247 participants at risk 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).
Blood and lymphatic system disorders Anaemia	0.42% 1/236 • Signing of informed consent for this open-label study to end of study (Up to 40 Weeks)	0.00% 0/247 • Signing of informed consent for this open-label study to end of study (Up to 40 Weeks)
Gastrointestinal disorders Abdominal pain	0.00% 0/236 • Signing of informed consent for this open-label study to end of study (Up to 40 Weeks)	0.40% 1/247 • Signing of informed consent for this open-label study to end of study (Up to 40 Weeks)
Gastrointestinal disorders Peptic ulcer	0.42% 1/236 • Signing of informed consent for this open-label study to end of study (Up to 40 Weeks)	0.00% 0/247 • Signing of informed consent for this open-label study to end of study (Up to 40 Weeks)
Metabolism and nutrition disorders Dehydration	0.00% 0/236 • Signing of informed consent for this open-label study to end of study (Up to 40 Weeks)	0.40% 1/247 • Signing of informed consent for this open-label study to end of study (Up to 40 Weeks)
Nervous system disorders Headache	0.42% 1/236 • Signing of informed consent for this open-label study to end of study (Up to 40 Weeks)	0.00% 0/247 • Signing of informed consent for this open-label study to end of study (Up to 40 Weeks)

Other adverse events

Other adverse events
Measure	Placebo/Sarecycline n=236 participants at risk Participants received placebo-matching 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).	Sarecycline/Sarecycline n=247 participants at risk 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).
Infections and infestations Nasopharyngitis	5.5% 13/236 • Signing of informed consent for this open-label study to end of study (Up to 40 Weeks)	2.0% 5/247 • Signing of informed consent for this open-label study to end of study (Up to 40 Weeks)

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

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