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Also known as XRP0038 (NV1FGF), riferminogene pecaplasmid, NV1FGF
XRP0038 · 6 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Riferminogene pecaplasmid | EXPERIMENTAL | 4 administrations of riferminogene pecaplasmid 4 mg at 2-week intervals |
| Placebo | PLACEBO_COMPARATOR | 4 administrations of placebo (for riferminogene pecaplasmid) at 2-week intervals |
| NV1FGF 16 mg | EXPERIMENTAL | 4 administrations at 2-week interval of 4mg at each administration |
| NV1FGF 32 mg | EXPERIMENTAL | 4 administrations at 2-week interval of 8mg at each administration |
| NV1FGF 500 μg | EXPERIMENTAL | 8 intramuscular injections for a total of 500 μg administered in one single administration 3 to 8 days before major amputation |
| NV1FGF 2000 μg | EXPERIMENTAL | 8 intramuscular injections for a total of 2000 μg administered in one single administration 3 to 8 days before major amputation |
| NV1FGF 4000 μg | EXPERIMENTAL | 8 intramuscular injections for a total of 4000 μg administered in one single administration 3 to 8 days before major amputation |
| Name | Type | Description |
|---|---|---|
| riferminogene pecaplasmid | BIOLOGICAL | Formulation: 5 ml glass vials containing 2,5 ml riferminogene pecaplasmid Route: intramuscular (IM) injection of 2.5 mL in the ischemic leg to be treated |
| Placebo (for riferminogene pecaplasmid) | BIOLOGICAL | Formulation: 5 ml glass vials containing 2,5 ml placebo Route: IM injection of 2.5 mL in the ischemic leg to be treated |
| XRP0038 (NV1FGF) | DRUG | Pharmaceutical form:solution Route of administration: intramuscular |
| placebo | DRUG | Pharmaceutical form:solution Route of administration: intramuscular |
Inclusion Criteria: * Having peripheral artery disease at the stage of Critical Limb Ischemia (CLI) with skin lesions (either ulcer(s) or gangrene); * With objective evidence of CLI such as ankle systolic pressure \<70 mmHg and/or toe systolic pressure \<50 mmHg or transcutaneous oxygen pressure (T...
XRP0038 is being studied for peripheral arterial disease, including peripheral arterial occlusive disease and severe peripheral artery occlusive disease. It is an investigational therapy developed by Sanofi. The clinical program has focused on patients with intermittent claudication and those with severe disease, including patients planned to undergo major amputation.
XRP0038 is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the clinical trial program evaluating the drug in peripheral arterial occlusive disease. The studies were conducted across sites in the United States, Belgium, Germany, Switzerland, and Finland.
XRP0038 has been studied in Phase 2 clinical development. Four completed trials are listed for the program, two of which are Phase 2 studies and two of which are Phase 1 studies. No active trials are currently listed, and the program has completed its registered studies.
XRP0038 has been evaluated in completed trials including NCT01157871, a Phase 2 dose-finding study in intermittent claudication, and NCT00798005, a Phase 2 efficacy and safety study in severe peripheral artery occlusive disease. Phase 1 studies NCT01157156 and NCT01157143 assessed safety, tolerability, and gene expression.
Yes, XRP0038 is also known as NV1FGF. The two names refer to the same investigational therapy developed by Sanofi for peripheral arterial disease. The clinical trials for this program are registered under the NV1FGF designation, so searches for either name lead to the same set of studies.
The XRP0038 clinical program enrolled a total of 125 patients across its completed trials. Individual study enrollment ranged from 6 patients in a Phase 1 gene expression and tolerability study to 71 patients in a Phase 2 efficacy and safety study in severe peripheral artery occlusive disease.