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

January 31, 2019 updated by: Almirall, S.A.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
490

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Actavis Investigational Study Site #206
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Actavis Investigational Study Site #236
    • California
      • Carlsbad, California, United States, 92008
        • Actavis Investigational Study Site #245
      • Encino, California, United States, 91436
        • Actavis Investigational Study Site #129
      • Fremont, California, United States, 94538
        • Actavis Investigational Study Site #209
      • Sacramento, California, United States, 95819
        • Actavis Investigational Study Site #147
      • San Diego, California, United States, 92120
        • Actavis Investigational Study Site #150
      • San Diego, California, United States, 92123
        • Actavis Investigational Study Site #125
      • San Diego, California, United States, 92123
        • Actavis Investigational Study Site #204
    • Colorado
      • Denver, Colorado, United States, 80220
        • Actavis Investigational Study Site #222
      • Wheat Ridge, Colorado, United States, 80033
        • Actavis Investigational Study Site #148
    • Florida
      • Clearwater, Florida, United States, 33761
        • Actavis Investigational Study Site #226
      • Jupiter, Florida, United States, 33458
        • Actavis Investigational Study Site #238
      • Miami, Florida, United States, 33142
        • Actavis Investigational Study Site #249
      • Miami, Florida, United States, 33175
        • Actavis Investigational Study Site #145
      • Miramar, Florida, United States, 33207
        • Actavis Investigational Study Site #211
      • North Miami Beach, Florida, United States, 33162
        • Actavis Investigation Study Site # 140
      • Orange, Florida, United States, 32073
        • Actavis Investigational Study Site #151
      • Tampa, Florida, United States, 33609
        • Actavis Investigational Study Site #203
    • Georgia
      • Snellville, Georgia, United States, 30078
        • Actavis Investigational Study Site #242
    • Idaho
      • Boise, Idaho, United States, 83704
        • Actavis Investigational Study Site #124
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Actavis Investigational Study Site #106
    • Indiana
      • South Bend, Indiana, United States, 46617
        • Actavis Investigational Study Site #113
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Actavis Investigational Study Site #213
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Actavis Investigational Study Site #217
    • Michigan
      • Clarkston, Michigan, United States, 48346
        • Actavis Investigational Study Site #251
      • Clinton Township, Michigan, United States, 48038
        • Actavis Investigational Study Site #235
      • Fort Gratiot, Michigan, United States, 48059
        • Actavis Investigational Study Site #227
      • Warren, Michigan, United States, 48088
        • Actavis Investigational Study Site #111
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Actavis Investigational Study Site #221
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Actavis Investigational Study Site #231
    • New York
      • New York, New York, United States, 10016
        • Actavis Investigational Study Site #146
      • New York, New York, United States, 10155
        • Actavis Investigational Study Site #208
      • Rochester, New York, United States, 14623
        • Actavis Investigational Study Site #240
      • Stony Brook, New York, United States, 11790
        • Actavis Investigational Study Site #230
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Actavis Investigational Study Site #229
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Actavis Investigational Study Site #149
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Actavis Investigational Study Site #257
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Actavis Investigational Study Site #225
      • Knoxville, Tennessee, United States, 37917
        • Actavis Investigational Study Site #128
      • Knoxville, Tennessee, United States, 37922
        • Actavis Investigational Study Site #216
      • Nashville, Tennessee, United States, 37215
        • Actavis Investigational Study Site #109
    • Texas
      • Arlington, Texas, United States, 76011
        • Actavis Investigational Study Site #223
      • Arlington, Texas, United States, 76011
        • Actavis Investigational Study Site #252
      • College Station, Texas, United States, 77845
        • Actavis Investigational Study Site #220
      • Dallas, Texas, United States, 75234
        • Actavis Investigational Study Site #104
      • Houston, Texas, United States, 77004
        • Actavis Investigational Study Site #142
      • Houston, Texas, United States, 77056
        • Actavis Investigational Study Site #105
      • Katy, Texas, United States, 77494
        • Actavis Investigational Study Site #201
      • Pflugerville, Texas, United States, 78660
        • Actavis Investigational Study Site #223
      • Plano, Texas, United States, 75093
        • Actavis Investigational Study Site #101
      • San Antonio, Texas, United States, 78218
        • Actavis Investigational Study Site #207
    • Utah
      • West Jordan, Utah, United States, 84088
        • Actavis Investigational Study Site #212
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Actavis Investigational Study Site #244
    • Washington
      • Spokane, Washington, United States, 99202
        • Actavis Investigational Study Site #144
      • Walla Walla, Washington, United States, 99362
        • Actavis Investigational Study Site #233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)
Time Frame: 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.
Up to 40 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Almirall, S.A.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Allergan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David Berk, MD, Allergan, plc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 26, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SC1403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acne Vulgaris

Clinical Trials on Sarecycline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings