A Phase 2 interventional study of Remlarsen and Placebo in Keloid, sponsored by miRagen Therapeutics, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-18.
Sponsored by miRagen Therapeutics, Inc. · Phase 2, Interventional, and Treatment
Remlarsen (MRG-201) is designed to mimic the activity of a molecule called miR-29 that decreases the expression of collagen and other proteins that are involved in scar formation. Remlarsen is being studied to determine if it can limit the formation of fibrous scar tissue in certain diseases. The objectives of this study are to investigate the safety and tolerability of remlarsen in subjects with a history of keloid scars, and to investigate the activity of remlarsen in prevention or reduction of keloid formation. Another objective is to study the pharmacokinetics of remlarsen (the movement of a drug into, through and out of the body). A group of 12-16 study volunteers will undergo two small skin biopsies in the upper back/shoulder region that will be closed with sutures. One biopsy site will be injected with up to 6 doses of remlarsen over a period of 2 weeks and the second site will be injected similarly with a placebo solution. Participants will be monitored for keloid formation at the two biopsy sites, for signs or symptoms of adverse effects on the body, and for the levels of remlarsen in the blood over time. A second 2-week cycle of treatment may be administered if there are signs that a keloid may be forming at one or both biopsy sites. Subjects will be followed for about 1 year following their final course of treatment to assess the long-term safety of remlarsen and the potential for later appearance of a keloid scar. Additional groups of subjects may be enrolled to test lower doses of remlarsen or an extended dosing schedule.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's enrollment of 14 is below the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →miRagen Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 will serve as their own simultaneous control.
Drug: Remlarsen
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 will serve as their own simultaneous control.
Drug: Placebo
Intradermal injection at site of one excisional wound
Also known as: MRG-201
Intradermal injection at site of second excisional wound
Percentage of Subjects With Confirmed Keloid Formation at Treated vs. Untreated Lesions at 24 Weeks
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
Percentage of Subjects With Improvement, Defined as no Confirmed Keloid Formation in the Treated Lesion vs. Confirmed Keloid Formation in the Untreated Lesion.
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
Percentage of Subjects With Confirmed Keloid Formation at Treated vs. Untreated Lesions at 52 Weeks
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
Time to Keloid Formation
Time to first confirmed keloid formation
Time frame: First dose to 365 days
Volume of Keloid at 24 Weeks
Time frame: 24 weeks from first dose
Volume of Keloid at 52 Weeks
Time frame: 52 weeks from first dose
Area Under the Plasma Concentration vs. Time Curve (AUC) of Remlarsen - Single Dose
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
Peak Plasma Concentration (Cmax) of Remlarsen - Single Dose
Peak plasma concentration (Cmax) of remlarsen + active metabolites (total active drug) after first dose
Time frame: First dose to 24 hours post-dose
Area Under the Plasma Concentration vs. Time Curve (AUC) of Remlarsen - Multi-dose
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
Peak Plasma Concentration (Cmax) of Remlarsen - Multi-dose
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
Participants were recruited based on physician referral at four medical centers
| Milestone | Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound |
|---|---|
| Started | 14 |
| Completed | 12 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 2 |
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.
| percentage of participants | Remlarsen-Treated Excisional Skin Wound | Placebo-Treated Excisional Skin Wound |
|---|---|---|
| Percentage of Subjects With Confirmed Keloid Formation at Treated vs. Untreated Lesions at 24 Weeks | 92.9 (66.13 to 99.82) | 85.7 (57.19 to 98.22) |
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.
No measurements were reported for this outcome.
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.
| percentage of participants | Remlarsen-Treated Excisional Skin Wound | Placebo-Treated Excisional Skin Wound |
|---|---|---|
| Percentage of Subjects With Confirmed Keloid Formation at Treated vs. Untreated Lesions at 52 Weeks | 100 (54.07 to 100.0) | 66.7 (22.28 to 95.67) |
Time to first confirmed keloid formation
| days | Remlarsen-Treated Excisional Skin Wound | Placebo-Treated Excisional Skin Wound |
|---|---|---|
| Time to Keloid Formation | 58 (29 to 85) | 55 (22 to 71) |
| millimeters cubed | Remlarsen-Treated Excisional Skin Wound | Placebo-Treated Excisional Skin Wound |
|---|---|---|
| Volume of Keloid at 24 Weeks | 65 ± 58 | 79 ± 55 |
| millimeters cubed | Remlarsen-Treated Excisional Skin Wound | Placebo-Treated Excisional Skin Wound |
|---|---|---|
| Volume of Keloid at 52 Weeks | 194 ± 142 | 156 ± 176 |
Area under the curve (AUClast) for remlarsen + active metabolites (total active drug) after a single dose
| ng*hr/mL | Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound |
|---|---|
| Area Under the Plasma Concentration vs. Time Curve (AUC) of Remlarsen - Single Dose | 461 ± 359 |
Peak plasma concentration (Cmax) of remlarsen + active metabolites (total active drug) after first dose
| ng/mL | Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound |
|---|---|
| Peak Plasma Concentration (Cmax) of Remlarsen - Single Dose | 29.3 ± 20.6 |
Area under the curve (AUClast) for remlarsen + active metabolites (total active drug) after multiple doses
| ng*hr/mL | Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound |
|---|---|
| Area Under the Plasma Concentration vs. Time Curve (AUC) of Remlarsen - Multi-dose | 1200 ± 383 |
Peak plasma concentration (Cmax) of remlarsen + active metabolites (total active drug) after multiple doses
| ng/mL | Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound |
|---|---|
| Peak Plasma Concentration (Cmax) of Remlarsen - Multi-dose | 75.5 ± 23.7 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment-emergent Adverse Events, Excluding Wound or Injection-site Related Events | 0/14 (0%) | 0/14 (0%) | 12/14 (85.7%) |
| Wound or Injection Site-related Treatment-emergent Adverse Events | 0/14 (0%) | 0/14 (0%) | 6/14 (42.9%) |
| Event | Treatment-emergent Adverse Events, Excluding Wound or Injection-site Related Events | Wound or Injection Site-related Treatment-emergent Adverse Events |
|---|---|---|
| Procedural painInjury, poisoning and procedural complications | 0/14 | 5/14 |
| Incision site pruritusInjury, poisoning and procedural complications | 0/14 | 5/14 |
| Blood lactate dehydrogenase increasedInvestigations | 4/14 | 0/14 |
| NasopharyngitisInfections and infestations | 3/14 | 0/14 |
| NauseaGastrointestinal disorders | 2/14 | 0/14 |
| DizzinessNervous system disorders | 2/14 | 0/14 |
| Urinary tract infectionInfections and infestations | 2/14 | 0/14 |
| Injection site oedemaGeneral disorders | 0/14 | 1/14 |
| Injection site erythemaGeneral disorders | 0/14 | 1/14 |
| Injection site painGeneral disorders | 0/14 | 1/14 |
| Age, Categorical(Participants) | Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 13 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound |
|---|---|
| Female | 9 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 10 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound |
|---|---|
| United States | 14 |
| Number of pre-existing keloids at screening(millimeters) | Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound |
|---|---|
| Mean | 10.7 ± 5.44 |
| Height of largest pre-existing keloid(millimeters) | Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound |
|---|---|
| Mean | 2.96 ± 3.96 |
| Width of largest pre-existing keloid(millimeters) | Remlarsen-Treated Excisional Skin Wound and Placebo-Treated Excisional Skin Wound |
|---|---|
| Mean | 26.0 ± 35.0 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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miRagen Therapeutics, Inc.