Overview

This trial is active, not recruiting.

Condition acne vulgaris
Treatment sarecycline
Phase phase 3
Sponsor Warner Chilcott
Start date March 2015
End date August 2016
Trial size 490 participants
Trial identifier NCT02413346, SC1403

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 subjects with moderate to severe facial acne vulgaris.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Sarecycline 1.5mg/kg given once daily for 40 weeks. Sarecycline will be administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the subject's body weight.
sarecycline
Administered based on patient body weight.

Primary Outcomes

Measure
Number of Adverse Event
time frame: up to Week 40

Eligibility Criteria

Male or female participants at least 9 years old.

Inclusion Criteria: - Successfully completed participation in Phase 3 study of saracycline (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

Additional Information

Official title A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Warner Chilcott.