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Label indication KEVZARA ® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). FDA label
Also known as Sarilumab, SAR153191, Kevzara®, Sarilumab Prophylaxis (Contingency)
REGN88 · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | dose 1 vs. placebo |
| 2 | ACTIVE_COMPARATOR | dose 2 vs. placebo |
| 3 | ACTIVE_COMPARATOR | dose 3 vs. placebo |
| 4 | ACTIVE_COMPARATOR | dose 4 vs. placebo |
| 5 | ACTIVE_COMPARATOR | dose 5 vs. placebo |
| 6 | ACTIVE_COMPARATOR | dose 6 vs. placebo |
| Dose 1 | EXPERIMENTAL | Active dose |
| Dose 2 | EXPERIMENTAL | Active dose |
| Dose 3 | EXPERIMENTAL | Active 3 |
| Dose 4 | PLACEBO_COMPARATOR | Placebo dose |
| Name | Type | Description |
|---|---|---|
| REGN88 | BIOLOGICAL | This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete. |
| Placebo | OTHER | Placebo to match REGN88 administration |
Inclusion Criteria: * Patients with an established diagnosis of Rheumatoid Arthritis * Patients currently treated with concomitant methotrexate for at least 12 weeks, with a stable dose for at least 6 weeks Exclusion Criteria: * Persistent chronic or current active infections * Patients who have ...
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REGN88 is an investigational small molecule developed by Regeneron Pharmaceuticals, Inc. (ticker REGN) for the treatment of rheumatoid arthritis. It has been studied in Phase 1 clinical trials. REGN88 is also known as SAR153191, so searches for either name refer to the same compound.
REGN88 is being developed for the treatment of rheumatoid arthritis, an inflammatory joint disease. All three of its Phase 1 trials enrolled adults with rheumatoid arthritis rather than healthy volunteers. The studies evaluated safety and tolerability, and REGN88 remains investigational rather than an approved rheumatoid arthritis therapy.
REGN88 targets IL-6R, the interleukin-6 receptor, a protein involved in inflammatory signaling. By binding IL-6R, the small molecule is designed to interfere with IL-6 receptor mediated inflammatory pathways relevant to rheumatoid arthritis. This target class is a protein, and the mechanism is the basis for studying REGN88 in inflammatory disease.
REGN88 is being developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. The compound also carries the code SAR153191, reflecting its study in rheumatoid arthritis. Regeneron is the sponsor associated with the Phase 1 clinical program for REGN88.
REGN88 is in Phase 1 clinical development. All three of its registered trials are Phase 1 studies, and all three are completed, with no active trials currently listed. REGN88 is investigational and has not been approved for marketing in rheumatoid arthritis or any other indication.
REGN88 has been studied in three completed Phase 1 trials in rheumatoid arthritis: NCT01055899, a single-dose safety study of 15 patients in the United States; NCT01026519, a safety and tolerability study of 32 patients in Russia; and NCT01011959, a multiple-dose safety and tolerability study of 60 patients in the United States.