Efficacy, Safety, and Tolerability of Remlarsen (MRG-201) Following Intradermal Injection in Subjects With a History of Keloids
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ClinicalTrials.gov Identifier: NCT03601052 |
Recruitment Status :
Completed
First Posted : July 26, 2018
Results First Posted : July 19, 2021
Last Update Posted : August 18, 2021
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Sponsor:
miRagen Therapeutics, Inc.
Information provided by (Responsible Party):
miRagen Therapeutics, Inc.
- Study Details
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Keloid |
Interventions |
Drug: Remlarsen Drug: Placebo |
Enrollment | 14 |
Participant Flow
Recruitment Details | Participants were recruited based on physician referral at four medical centers |
Pre-assignment Details |
Arm/Group Title | Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound |
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Six doses remlarsen (5.3 mg) over a period of 2 weeks at the site of one excisional skin wound and six doses Placebo over the same period at the site of a second excisional skin wound. Each subject served as their own simultaneous control. |
Period Title: Overall Study | |
Started | 14 |
Completed | 12 |
Not Completed | 2 |
Reason Not Completed | |
Lost to Follow-up | 2 |
Baseline Characteristics
Arm/Group Title | Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound | |
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Six doses remlarsen (5.3 mg) over a period of 2 weeks at the site of one excisional skin wound and six doses Placebo over the same period at the site of a second excisional skin wound. Each subject served as their own simultaneous control. | |
Overall Number of Baseline Participants | 14 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 14 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
13 92.9%
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>=65 years |
1 7.1%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 14 participants | |
Female |
9 64.3%
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Male |
5 35.7%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 14 participants | |
Hispanic or Latino |
4 28.6%
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Not Hispanic or Latino |
10 71.4%
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Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 14 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
10 71.4%
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White |
4 28.6%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 14 participants |
14 | ||
Number of pre-existing keloids at screening
Mean (Standard Deviation) Unit of measure: Millimeters |
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Number Analyzed | 14 participants | |
10.7 (5.44) | ||
Height of largest pre-existing keloid
Mean (Standard Deviation) Unit of measure: Millimeters |
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Number Analyzed | 14 participants | |
2.96 (3.96) | ||
Width of largest pre-existing keloid
Mean (Standard Deviation) Unit of measure: Millimeters |
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Number Analyzed | 14 participants | |
26.0 (35.0) | ||
Length of largest pre-existing keloid
Mean (Standard Deviation) Unit of measure: Millimeters |
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Number Analyzed | 14 participants | |
89.9 (83.6) | ||
Volume of largest pre-existing keloid
Mean (Standard Deviation) Unit of measure: Millimeters cubed |
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Number Analyzed | 14 participants | |
10,366 (22,607) |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Investigators in this study may present or publish study results in scientific journals or other scholarly media without prior written approval after the following conditions have been met:
- Results of study have been publicly disclosed by or with the consent of the sponsor
- Investigator has complied with the Clinical Trial Agreement and requests from the sponsor to delete confidential information (other than study results)
- Study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: | Regulatory Affairs |
Organization: | Viridian Therapeutics (formerly miRagen Therapeutics) |
Phone: | 720-722-5917 |
EMail: | clinicaltrials@viridiantherapeutics.com |
Responsible Party: | miRagen Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03601052 |
Other Study ID Numbers: |
MRG201-30-201 |
First Submitted: | July 6, 2018 |
First Posted: | July 26, 2018 |
Results First Submitted: | June 28, 2021 |
Results First Posted: | July 19, 2021 |
Last Update Posted: | August 18, 2021 |