drugset / Trial / NCT03410056

Safety and Efficacy of Efavaleukin Alfa in Subjects With Active Rheumatoid Arthritis

NCT03410056 ↗

Phase 1/2 Terminated 36 enrolled Amgen
RandomizedSequentialDouble-blindTreatment

Summary

Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin alfa in subjects with active rheumatoid arthritis (RA). Phase 2a. To evaluate the efficacy of Efavaleukin alfa at week 12 as measured by the American College of Rheumatology 20 percent improvement criteria (ACR 20) in adult subjects with moderate to severe RA.

Timeline

Start
2018-05-22
Primary completion
2019-12-10
Completion
2020-05-13

Outcome

Outcome not reported

Stopped (Business): “Amgen made a business decision not to proceed with Phase 2.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Efavaleukin alfa Protein / enzyme biologic — Subcutaneous

Indications