NCT04680637

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

A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Active Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Efavaleukin Alfa	Administered as a subcutaneous (SC) injection.
DRUG	Placebo	Administered as a subcutaneous (SC) injection.
OTHER	Standard of Care	Standard of care procedures and therapies for managing active systemic lupus erythematosus will be carried out according to each investigator's standard procedures.

Timeline

• Start date: 2021-05-06
• Primary completion: 2023-05-22
• Completion: 2023-05-22
• First posted: 2020-12-23
• Last updated: 2024-06-28
• Results posted: 2024-06-28

Locations

150 sites across 19 countries: United States, Austria, Bulgaria, Canada, Chile, Colombia, France, Greece, Hong Kong, Italy, Japan, Mexico, Poland, Russia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study