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
Last Update Posted : November 20, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Keloid | Drug: Remlarsen Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Up to 6 cohorts of 12-16 subjects each may be enrolled to study various dose levels and dosing regimens. |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | The treatment administered to each of two wound sites will be randomized (left versus right), such that all subjects will receive both remlarsen and placebo in a double-blinded fashion. |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Double-blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of MRG-201 Following Intradermal Injection in Subjects With a History of Keloids |
Actual Study Start Date : | June 11, 2018 |
Actual Primary Completion Date : | June 24, 2020 |
Actual Study Completion Date : | June 24, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1 - Remlarsen (L) vs. Placebo (R)
Six doses remlarsen (5.3 mg) over a period of 2 weeks at the site of one excisional skin wound (left side) and six doses Placebo over a period of 2 weeks at the site of a second excisional skin wound (right side). Each subject will serve as their own control.
|
Drug: Remlarsen
Intradermal injection at site of one excisional wound
Other Name: MRG-201 Drug: Placebo Intradermal injection at site of second excisional wound |
Experimental: Cohort 1 - Remlarsen (R) vs. Placebo (L)
Six doses remlarsen (5.3 mg) over a period of 2 weeks at the site of one excisional skin wound (right side) and six doses Placebo over a period of 2 weeks at the site of a second excisional skin wound (left side). Each subject will serve as their own control.
|
Drug: Remlarsen
Intradermal injection at site of one excisional wound
Other Name: MRG-201 Drug: Placebo Intradermal injection at site of second excisional wound |
- Proportion of confirmed keloid formation across subjects for treated vs. untreated lesions. [ Time Frame: Up to 365 days ]
- Proportion of subjects with improvement, defined as no confirmed keloid formation in the treated lesion vs. confirmed keloid formation in the untreated lesion. [ Time Frame: Up to 365 days ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to 365 days ]
- Area under the plasma concentration vs. time curve (AUC) of remlarsen [ Time Frame: Up to 27 days ]
- Peak plasma concentration (Cmax) of remlarsen [ Time Frame: Up to 27 days ]
- Time to keloid formation [ Time Frame: Up to 365 days ]
- Volume of keloid [ Time Frame: Up to 365 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Must provide written informed consent.
- Females must not be pregnant, or lactating, and have negative pregnancy tests.
- Study candidates should be likely to form keloids in the upper back/shoulder area after punch biopsy based on a history of a high frequency of keloid formation (≥ 10 keloids) or a history of large keloids (≥ 4 cm).
- Subjects should not anticipate requiring systemic corticosteroids during the study.
- Must have area in upper back/shoulder region free of keloids, acne, striae, or other skin pathologies or complications.
- Female subjects of childbearing potential or male subjects engaged in sexual relations with a female of childbearing potential must be willing to use a highly effective method of contraception throughout their study participation and for at least 6 months after the last dose of study drug.
Key Exclusion Criteria:
- Clinically significant abnormalities in medical history or physical exam that, in the opinion of the Investigator, would make the subject unsuitable for inclusion in the study.
- History of genetic disorders that predispose to keloids (e.g. Ehlers-Danlos syndrome, Ullrich congenital muscular dystrophy, etc.).
- History of renal or liver dysfunction or evidence of renal or liver dysfunction at screening.
- Evidence of clinically significant anemia, neutropenia, or thrombocytopenia at screening.
- History of bleeding diathesis or coagulopathy.
- Active or uncontrolled infection at screening or baseline.
- Recent history of alcoholism, drug abuse or illicit drugs (within the last year), and agreement to refrain from using illicit drugs throughout the study.
- Positive for bloodborne pathogen (HBV, HCV, HIV) at screening.
- Prior malignancies within the past 3 years (allowing squamous cell and basal cell carcinomas that have been successfully treated).
- Use of systemic steroids within 4 weeks of the Baseline visit or local use of steroids within 1 week of the Baseline visit.
- Use of an investigational small molecule drug within 30 days of the baseline visit or use of an investigational oligonucleotide or biologic drug within 90 days of the baseline visit.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601052
United States, Florida | |
Center for Clinical and Cosmetic Research | |
Aventura, Florida, United States, 33180 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, Michigan | |
Henry Ford Health System | |
Detroit, Michigan, United States, 48202 | |
United States, Texas | |
J & S Studies | |
College Station, Texas, United States, 77845 |
Study Director: | Diana M Escolar, MD, FAAN | miRagen Therapeutics, Inc. |
Responsible Party: | miRagen Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03601052 |
Other Study ID Numbers: |
MRG201-30-201 |
First Posted: | July 26, 2018 Key Record Dates |
Last Update Posted: | November 20, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Keloid MicroRNAs Wound healing |
Keloid Collagen Diseases Connective Tissue Diseases |
Cicatrix Fibrosis Pathologic Processes |