We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy, Safety, and Tolerability of Remlarsen (MRG-201) Following Intradermal Injection in Subjects With a History of Keloids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03601052
Recruitment Status : Completed
First Posted : July 26, 2018
Results First Posted : July 19, 2021
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
miRagen Therapeutics, Inc.

Study Type Interventional
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
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
Hide Arm/Group Description 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
Arm/Group Title Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  92.9%
>=65 years
1
   7.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
9
  64.3%
Male
5
  35.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Hispanic or Latino
4
  28.6%
Not Hispanic or Latino
10
  71.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
10
  71.4%
White
4
  28.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
Number of pre-existing keloids at screening  
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 14 participants
10.7  (5.44)
Height of largest pre-existing keloid  
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 14 participants
2.96  (3.96)
Width of largest pre-existing keloid  
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 14 participants
26.0  (35.0)
Length of largest pre-existing keloid  
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 14 participants
89.9  (83.6)
Volume of largest pre-existing keloid  
Mean (Standard Deviation)
Unit of measure:  Millimeters cubed
Number Analyzed 14 participants
10,366  (22,607)
1.Primary Outcome
Title Percentage of Subjects With Confirmed Keloid Formation at Treated vs. Untreated Lesions at 24 Weeks
Hide Description The percentage of subjects with confirmed keloid formation at treated versus untreated lesions at 24 weeks (± 7 days) after first dose, analyzed using the modified Vancouver Scar Scale which reports a cumulative score based on subscores for vascularity, pliability and height.
Time Frame 24 weeks (± 7 days) from first dose
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects for whom an assessment of keloid formation using the modified Vancouver Scar Scale was performed at 24 weeks (± 7 days). Subjects who did not have keloid assessments within this time window were not included in the analysis.
Arm/Group Title Remlarsen-Treated Excisional Skin Wound Placebo-Treated Excisional Skin Wound
Hide Arm/Group Description:
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.
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 Participants Analyzed 14 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
92.9
(66.13 to 99.82)
85.7
(57.19 to 98.22)
2.Other Pre-specified Outcome
Title Percentage of Subjects With Improvement, Defined as no Confirmed Keloid Formation in the Treated Lesion vs. Confirmed Keloid Formation in the Untreated Lesion.
Hide Description Percentage of subjects with improvement at 24 weeks (± 7 days), defined as no confirmed keloid formation in the treated lesion vs. confirmed keloid formation in the untreated lesion, based on assessment using the modified Vancouver Scar Scale which reports a cumulative score based on subscores for vascularity, pliability and height.
Time Frame 24 weeks (± 7 days) from first dose
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects for whom an analysis of improvement, defined as no confirmed keloid formation in the treated lesion vs. confirmed keloid formation in the untreated lesion based on assessment using the modified Vancouver Scar Scale, was performed at 24 weeks (± 7 days). Subjects who did not have an analysis of improvement, as defined, were not included in this outcome measure.
Arm/Group Title Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound
Hide Arm/Group Description:
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 Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Other Pre-specified Outcome
Title Percentage of Subjects With Confirmed Keloid Formation at Treated vs. Untreated Lesions at 52 Weeks
Hide Description The percentage of subjects with confirmed keloid formation at treated versus untreated lesions at 52 weeks (± 7 days) after first dose, analyzed using the modified Vancouver Scar Scale which reports a cumulative score based on subscores for vascularity, pliability and height.
Time Frame 52 weeks (± 7 days) from first dose
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects for whom an assessment of keloid formation using the modified Vancouver Scar Scale was performed at 52 weeks (± 7 days). Subjects who did not have keloid assessments within this time window were not included in the analysis.
Arm/Group Title Remlarsen-Treated Excisional Skin Wound Placebo-Treated Excisional Skin Wound
Hide Arm/Group Description:

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.

Remlarsen: Intradermal injection at site of one excisional wound

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.

Placebo: Intradermal injection at site of second excisional wound

Overall Number of Participants Analyzed 6 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(54.07 to 100.0)
66.7
(22.28 to 95.67)
4.Other Pre-specified Outcome
Title Time to Keloid Formation
Hide Description Time to first confirmed keloid formation
Time Frame First dose to 365 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remlarsen-Treated Excisional Skin Wound Placebo-Treated Excisional Skin Wound
Hide Arm/Group Description:
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.
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 Participants Analyzed 14 14
Median (95% Confidence Interval)
Unit of Measure: days
58
(29 to 85)
55
(22 to 71)
5.Other Pre-specified Outcome
Title Volume of Keloid at 24 Weeks
Hide Description [Not Specified]
Time Frame 24 weeks from first dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remlarsen-Treated Excisional Skin Wound Placebo-Treated Excisional Skin Wound
Hide Arm/Group Description:
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.
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 Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: millimeters cubed
65  (58) 79  (55)
6.Other Pre-specified Outcome
Title Volume of Keloid at 52 Weeks
Hide Description [Not Specified]
Time Frame 52 weeks from first dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remlarsen-Treated Excisional Skin Wound Placebo-Treated Excisional Skin Wound
Hide Arm/Group Description:
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.
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 Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: millimeters cubed
194  (142) 156  (176)
7.Other Pre-specified Outcome
Title Area Under the Plasma Concentration vs. Time Curve (AUC) of Remlarsen - Single Dose
Hide Description Area under the curve (AUClast) for remlarsen + active metabolites (total active drug) after a single dose
Time Frame First dose to 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound
Hide Arm/Group Description:
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 Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
461  (359)
8.Other Pre-specified Outcome
Title Peak Plasma Concentration (Cmax) of Remlarsen - Single Dose
Hide Description Peak plasma concentration (Cmax) of remlarsen + active metabolites (total active drug) after first dose
Time Frame First dose to 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound
Hide Arm/Group Description:
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 Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: ng/mL
29.3  (20.6)
9.Other Pre-specified Outcome
Title Area Under the Plasma Concentration vs. Time Curve (AUC) of Remlarsen - Multi-dose
Hide Description Area under the curve (AUClast) for remlarsen + active metabolites (total active drug) after multiple doses
Time Frame First dose to up to 13 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound
Hide Arm/Group Description:
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 Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
1200  (383)
10.Other Pre-specified Outcome
Title Peak Plasma Concentration (Cmax) of Remlarsen - Multi-dose
Hide Description Peak plasma concentration (Cmax) of remlarsen + active metabolites (total active drug) after multiple doses
Time Frame Dosing on Day 10 or Day 12 through 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound
Hide Arm/Group Description:
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 Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
75.5  (23.7)
Time Frame All adverse events from clinical trial initiation until 30 days post-dose regardless of relationship, and Related events until the end of the protocol-specified observation period.
Adverse Event Reporting Description Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
 
Arm/Group Title Treatment-emergent Adverse Events, Excluding Wound or Injection-site Related Events Wound or Injection Site-related Treatment-emergent Adverse Events
Hide Arm/Group Description All subjects; all treatment-emergent adverse events, excluding wound or injection site-related events All subjects; wound or injection site-related treatment-emergent adverse events
All-Cause Mortality
Treatment-emergent Adverse Events, Excluding Wound or Injection-site Related Events Wound or Injection Site-related Treatment-emergent Adverse Events
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/14 (0.00%)    
Hide Serious Adverse Events
Treatment-emergent Adverse Events, Excluding Wound or Injection-site Related Events Wound or Injection Site-related Treatment-emergent Adverse Events
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/14 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment-emergent Adverse Events, Excluding Wound or Injection-site Related Events Wound or Injection Site-related Treatment-emergent Adverse Events
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/14 (85.71%)      6/14 (42.86%)    
Eye disorders     
Visual impairment  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain lower  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Constipation  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Diarrhoea  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Nausea  1  2/14 (14.29%)  3 0/14 (0.00%)  0
Toothache  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Vomiting  1  1/14 (7.14%)  1 0/14 (0.00%)  0
General disorders     
Injection site oedema  1  0/14 (0.00%)  0 1/14 (7.14%)  1
Injection site erythema  1  0/14 (0.00%)  0 1/14 (7.14%)  1
Injection site pain  1  0/14 (0.00%)  0 1/14 (7.14%)  1
Injection site reaction  1  0/14 (0.00%)  0 1/14 (7.14%)  1
Chills  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Pyrexia  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Asthenia  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Infections and infestations     
Fungal infection  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Influenza  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Urinary tract infection  1  2/14 (14.29%)  3 0/14 (0.00%)  0
Groin infection  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Hordeolum  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Nasopharyngitis  1  3/14 (21.43%)  3 0/14 (0.00%)  0
Sinusitis  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Injury, poisoning and procedural complications     
Procedural pain  1  0/14 (0.00%)  0 5/14 (35.71%)  6
Incision site pruritus  1  0/14 (0.00%)  0 5/14 (35.71%)  6
Arthropod bite  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Muscle strain  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Wound haematoma  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Investigations     
Red blood cell count decreased  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Blood creatine phosphokinase increased  1  1/14 (7.14%)  2 0/14 (0.00%)  0
Blood lactate dehydrogenase increased  1  4/14 (28.57%)  11 0/14 (0.00%)  0
Monocyte count increased  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Neutrophil count increased  1  1/14 (7.14%)  1 0/14 (0.00%)  0
White blood cell count increased  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Metabolism and nutrition disorders     
Hypercholesterolemia  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Glucose tolerance impaired  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Vitamin D deficiency  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Intervertebral disc degeneration  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Back pain  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Nervous system disorders     
Dizziness  1  2/14 (14.29%)  2 0/14 (0.00%)  0
Headache  1  1/14 (7.14%)  2 0/14 (0.00%)  0
Renal and urinary disorders     
Urine odour abnormal  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Paranasal sinus discomfort  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Rhinorrhoea  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Oropharyngeal pain  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Blister  1  1/14 (7.14%)  1 0/14 (0.00%)  0
Urticaria  1  1/14 (7.14%)  1 0/14 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Certain Agreements
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
Layout table for Results Point of Contact information
Name/Title: Regulatory Affairs
Organization: Viridian Therapeutics (formerly miRagen Therapeutics)
Phone: 720-722-5917
EMail: clinicaltrials@viridiantherapeutics.com
Layout table for additonal information
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