Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN475 · 4 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Group A will receive REGN475 dosing regimen 1 |
| Group B | EXPERIMENTAL | Group B will receive REGN475 dosing regimen 2 |
| Group C | EXPERIMENTAL | Group C will receive REGN475 dosing regimen 3 |
| Group D | EXPERIMENTAL | Group D will receive REGN475 dosing regimen 4 |
| Group E | EXPERIMENTAL | Group E will receive matching placebo |
| placebo injection | PLACEBO_COMPARATOR | - |
| active | EXPERIMENTAL | subcutaneous injection of REGN475 |
| active 2 | EXPERIMENTAL | subcutaneous injection of REGN475 |
| Dose 1 | EXPERIMENTAL | - |
| Dose 2 | EXPERIMENTAL | - |
| Dose 3 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Cohort 1 | ACTIVE_COMPARATOR | Dose 1 REGN475 |
| Cohort 2 | ACTIVE_COMPARATOR | Dose 2 of REGN475 |
| Cohort 3 | ACTIVE_COMPARATOR | Dose 2 of REGN475 |
| Cohort 4 | ACTIVE_COMPARATOR | Dose 1 of REGN475 |
| Cohort 5 | ACTIVE_COMPARATOR | Dose 2 of REGN475 |
| Cohort 6 | ACTIVE_COMPARATOR | Dose 1 REGN475 subcutaneous administration |
| Cohort 7 | ACTIVE_COMPARATOR | Dose 2 REGN475 subcutaneous administration |
| Name | Type | Description |
|---|---|---|
| REGN475 | DRUG | - |
| Placebo | DRUG | - |
| Placebo Injection | DRUG | Placebo Subcutaneous injection |
| REGN475 (SAR164877) | BIOLOGICAL | Subcutaneous administration REGN475 (SAR164877) |
Key Inclusion Criteria: 1. Body mass index ≤39 2. Clinical diagnosis of OA of the knee or hip 3. History of inadequate pain relief or intolerance to analgesics used for OA 4. Moderate to severe pain in the index joint 5. History of regular use of analgesic medications for OA pain 6. Willing to disc...
REGN475 is an investigational monoclonal antibody being studied for pain conditions, including osteoarthritis of the knee and hip, and sciatica. It has been evaluated in clinical trials for these indications, though it remains in clinical development and is not approved.
REGN475 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. The drug has also been referred to as SAR164877 in some clinical trial records.
REGN475 has completed Phase 1 and Phase 2 clinical trials. These trials investigated its safety and efficacy in healthy subjects, patients with osteoarthritis of the knee, and patients with sciatic pain. The drug is investigational and not approved.
REGN475 has been studied in several completed trials, including NCT00856310 in healthy subjects, NCT00944892 in patients with osteoarthritis of the knee, NCT00991172 in patients with sciatic pain, and NCT02447276 in patients with pain due to osteoarthritis of the knee or hip.
Yes, REGN475 is also known as SAR164877. Clinical trial records for the drug list both names, such as in NCT00856310, which is titled 'A Single-Dose Study of the Safety and Tolerability of REGN475(SAR164877) in Healthy Subjects.'