Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03601052 | Efficacy, Safety, and Tolerability of Remlarsen (MRG-201) Following Intradermal Injection in Subjects With a History of Keloids | PHASE2 | COMPLETED | 14 | — | — | Jun 11, 2018 | Jun 24, 2020 | Aug 18, 2021 | 4 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Remlarsen - Intradermal | EXPERIMENTAL | 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. |
| Placebo - Intradermal | PLACEBO_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Remlarsen | DRUG | Intradermal injection at site of one excisional wound |
| Placebo | DRUG | Intradermal injection at site of second excisional wound |
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 f...