Regeneron registers Phase 3 PICC clot-prevention trial; Sanofi runs sarilumab study as collaborator

Regeneron posted three new clinical trial registrations this week, ranging from a large Phase 3 prevention study to an early-phase dosing trial and an observational allergy characterization study.

• Regeneron registered a Phase 3 trial called "ROXI-PEAK" testing two antibodies, REGN7508 (cenvacibart) and REGN9933 (amrecibart), to see how well REGN7508 and REGN9933 prevent blood clots compared to placebo after PICC placement and to see if these medications cause certain types of bleeding.¹ The study is not yet recruiting and plans to enroll participants undergoing PICC placement for Intravenous (IV) administration of clinically indicated medications, including chemotherapy, antibiotics, TPN, and/or other indications as described in the protocol¹ with an estimated enrollment of 1908.
• Sanofi is sponsoring a Phase 1b/2 study of intravenous sarilumab in rheumatoid arthritis, called "OPALS," with Regeneron as collaborator. The purpose of this study is to measure PK parameters and safety with sarilumab intravenous (IV) with or without concomitant oral conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) in male and female participants with moderately to severely active rheumatoid arthritis aged 18 years of age or older.² The study is recruiting, with estimated enrollment of 140.
• Regeneron registered an observational study, the "Patient Identification and Characterization (PIC) Study," to screen for future cat and birch allergy research. The purpose is to collect information and perform limited allergy-related procedures to determine if participants can qualify for cat and/or birch tree pollen allergy clinical research studies in the future, and to look at how these allergies have affected overall health.³ The study is not yet recruiting, with estimated enrollment of 1500.