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

• Sponsor: Almirall, S.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02413346
• Collaborator: Allergan (Industry)
• Enrollment: 490
• Locations: 56
• Arms: 2
• Actual Duration (Months): 17.2
• Patients Per Site: 8.8
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Sarecycline	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 490 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris
• Actual Study Start Date: Mar 20, 2015
• Actual Primary Completion Date: Aug 26, 2016
• Actual Study Completion Date: Aug 26, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Drug: Sarecycline; Administered based on participant's body weight.
Experimental: 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).	Drug: Sarecycline; Administered based on participant's body weight.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE) [Up to 40 Weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Actavis Investigational Study Site #206	Mobile	Alabama	United States	36608
2	Actavis Investigational Study Site #236	Hot Springs	Arkansas	United States	71913
3	Actavis Investigational Study Site #245	Carlsbad	California	United States	92008
4	Actavis Investigational Study Site #129	Encino	California	United States	91436
5	Actavis Investigational Study Site #209	Fremont	California	United States	94538
6	Actavis Investigational Study Site #147	Sacramento	California	United States	95819
7	Actavis Investigational Study Site #150	San Diego	California	United States	92120
8	Actavis Investigational Study Site #125	San Diego	California	United States	92123
9	Actavis Investigational Study Site #204	San Diego	California	United States	92123
10	Actavis Investigational Study Site #222	Denver	Colorado	United States	80220
11	Actavis Investigational Study Site #148	Wheat Ridge	Colorado	United States	80033
12	Actavis Investigational Study Site #226	Clearwater	Florida	United States	33761
13	Actavis Investigational Study Site #238	Jupiter	Florida	United States	33458
14	Actavis Investigational Study Site #249	Miami	Florida	United States	33142
15	Actavis Investigational Study Site #145	Miami	Florida	United States	33175
16	Actavis Investigational Study Site #211	Miramar	Florida	United States	33207
17	Actavis Investigation Study Site # 140	North Miami Beach	Florida	United States	33162
18	Actavis Investigational Study Site #151	Orange	Florida	United States	32073
19	Actavis Investigational Study Site #203	Tampa	Florida	United States	33609
20	Actavis Investigational Study Site #242	Snellville	Georgia	United States	30078
21	Actavis Investigational Study Site #124	Boise	Idaho	United States	83704
22	Actavis Investigational Study Site #106	Chicago	Illinois	United States	60611
23	Actavis Investigational Study Site #113	South Bend	Indiana	United States	46617
24	Actavis Investigational Study Site #213	Louisville	Kentucky	United States	40202
25	Actavis Investigational Study Site #217	Rockville	Maryland	United States	20850
26	Actavis Investigational Study Site #251	Clarkston	Michigan	United States	48346
27	Actavis Investigational Study Site #235	Clinton Township	Michigan	United States	48038
28	Actavis Investigational Study Site #227	Fort Gratiot	Michigan	United States	48059
29	Actavis Investigational Study Site #111	Warren	Michigan	United States	48088
30	Actavis Investigational Study Site #221	Fridley	Minnesota	United States	55432
31	Actavis Investigational Study Site #231	Omaha	Nebraska	United States	68144
32	Actavis Investigational Study Site #146	New York	New York	United States	10016
33	Actavis Investigational Study Site #208	New York	New York	United States	10155
34	Actavis Investigational Study Site #240	Rochester	New York	United States	14623
35	Actavis Investigational Study Site #230	Stony Brook	New York	United States	11790
36	Actavis Investigational Study Site #229	Raleigh	North Carolina	United States	27612
37	Actavis Investigational Study Site #149	Gresham	Oregon	United States	97030
38	Actavis Investigational Study Site #257	Philadelphia	Pennsylvania	United States	19103
39	Actavis Investigational Study Site #225	Goodlettsville	Tennessee	United States	37072
40	Actavis Investigational Study Site #128	Knoxville	Tennessee	United States	37917
41	Actavis Investigational Study Site #216	Knoxville	Tennessee	United States	37922
42	Actavis Investigational Study Site #109	Nashville	Tennessee	United States	37215
43	Actavis Investigational Study Site #223	Arlington	Texas	United States	76011
44	Actavis Investigational Study Site #252	Arlington	Texas	United States	76011
45	Actavis Investigational Study Site #220	College Station	Texas	United States	77845
46	Actavis Investigational Study Site #104	Dallas	Texas	United States	75234
47	Actavis Investigational Study Site #142	Houston	Texas	United States	77004
48	Actavis Investigational Study Site #105	Houston	Texas	United States	77056
49	Actavis Investigational Study Site #201	Katy	Texas	United States	77494
50	Actavis Investigational Study Site #223	Pflugerville	Texas	United States	78660
51	Actavis Investigational Study Site #101	Plano	Texas	United States	75093
52	Actavis Investigational Study Site #207	San Antonio	Texas	United States	78218
53	Actavis Investigational Study Site #212	West Jordan	Utah	United States	84088
54	Actavis Investigational Study Site #244	Norfolk	Virginia	United States	23507
55	Actavis Investigational Study Site #144	Spokane	Washington	United States	99202
56	Actavis Investigational Study Site #233	Walla Walla	Washington	United States	99362

Sponsors and Collaborators

• Almirall, S.A.
• Allergan

Investigators

• Study Director: David Berk, MD, Allergan, plc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Almirall, S.A.
• ClinicalTrials.gov Identifier: NCT02413346
• Other Study ID Numbers: SC1403
• First Posted: Apr 9, 2015
• Last Update Posted: Feb 1, 2019
• Last Verified: Jan 1, 2019

• Additional relevant MeSH terms: Acne Vulgaris; Sarecycline

Study Results

Participant Flow

Recruitment Details	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].

Arm/Group Title	Placebo/Sarecycline	Sarecycline/Sarecycline
Arm/Group 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).
Period Title: Overall Study
STARTED	236	247
COMPLETED	177	177
NOT COMPLETED	59	70

Baseline Characteristics

Arm/Group Title	Placebo/Sarecycline	Sarecycline/Sarecycline	Total
Arm/Group Description	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).	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 of all reporting groups
Overall Participants	236	247	483
Age, Customized (participants) [Number]
≥9 and <12 years	2 0.8%	3 1.2%	5 1%
≥12 and <18 years	138 58.5%	152 61.5%	290 60%
≥18 years	96 40.7%	92 37.2%	188 38.9%
Sex: Female, Male (Count of Participants)
Female	122 51.7%	125 50.6%	247 51.1%
Male	114 48.3%	122 49.4%	236 48.9%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo/Sarecycline	Sarecycline/Sarecycline
Arm/Group Description	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).	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).
Measure Participants	236	247
Number [participants]	94 39.8%	94 38.1%

Adverse Events

Time Frame	Signing of informed consent for this open-label study to end of study (Up to 40 Weeks)
Arm/Group Title	Placebo/Sarecycline		Sarecycline/Sarecycline
Arm/Group Description	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).		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).
All Cause Mortality
	Placebo/Sarecycline		Sarecycline/Sarecycline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/236 (0%)		0/247 (0%)
Serious Adverse Events
	Placebo/Sarecycline		Sarecycline/Sarecycline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/236 (0.8%)		2/247 (0.8%)
Blood and lymphatic system disorders
Anaemia	1/236 (0.4%)		0/247 (0%)
Gastrointestinal disorders
Abdominal pain	0/236 (0%)		1/247 (0.4%)
Peptic ulcer	1/236 (0.4%)		0/247 (0%)
Metabolism and nutrition disorders
Dehydration	0/236 (0%)		1/247 (0.4%)
Nervous system disorders
Headache	1/236 (0.4%)		0/247 (0%)
Other (Not Including Serious) Adverse Events
	Placebo/Sarecycline		Sarecycline/Sarecycline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/236 (5.5%)		5/247 (2%)
Infections and infestations
Nasopharyngitis	13/236 (5.5%)		5/247 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.