Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus

Phase 2 Terminated 168 enrolled Amgen

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.

Timeline

Start: 2021-05-06
Primary completion: 2023-05-22
Completion: 2023-05-22

Outcome

Missed primary endpoint

Stopped: “The trial was terminated prematurely as it met pre-defined criteria for futility at IA3.”

release “Efavaleukin alfa (AMG 592) A Phase 2b study of efavaleukin alfa, an interleukin-2 (IL-2) mutein Fc fusion protein, in SLE was stopped for futility.” amgen.com ↗

Publications

Garces S, Karis E, Merrill JT, Askanase AD, Kalunian K, Mo M, Milmont CE. Improving resource utilisation in SLE drug development through innovative trial design. Lupus Sci Med. 2023 Jul;10(2):e000890. doi: 10.1136/lupus-2022-000890.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Efavaleukin alfa	Protein / enzyme biologic	—	Subcutaneous