Efficacy, Safety, and Tolerability of MRG-201 Following Intradermal Injection in Subjects With a History of Keloids
| Status: | Recruiting |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/15/2018 |
| Start Date: | July 9, 2018 |
| End Date: | August 2019 |
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
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. MRG-201 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
MRG-201 in subjects with a history of keloid scars, and to investigate the activity of
MRG-201 in prevention or reduction of keloid formation. Another objective is to study the
pharmacokinetics of MRG-201 (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 MRG-201 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
MRG-201 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 MRG-201 and the potential for later appearance of a keloid scar. Additional groups
of subjects may be enrolled to test lower doses of MRG-201 or an extended dosing schedule.
expression of collagen and other proteins that are involved in scar formation. MRG-201 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
MRG-201 in subjects with a history of keloid scars, and to investigate the activity of
MRG-201 in prevention or reduction of keloid formation. Another objective is to study the
pharmacokinetics of MRG-201 (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 MRG-201 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
MRG-201 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 MRG-201 and the potential for later appearance of a keloid scar. Additional groups
of subjects may be enrolled to test lower doses of MRG-201 or an extended dosing schedule.
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.
We found this trial at
4
sites
303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Roopal V. Kundu, MD
Phone: 312-503-5906
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Aventura, Florida 33180
Principal Investigator: Brian Berman, MD, PhD
Phone: 305-933-6716
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College Station, Texas 77845
Principal Investigator: Terry M. Jones, MD
Phone: 979-774-5933
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Detroit, Michigan 48202
Principal Investigator: David M. Ozog, MD
Phone: 313-676-9672
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