NCT03410056

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

A Phase 1b/2a Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa in Subjects With Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rheumatoid Arthritis RA

Interventions

Type	Name	Description
DRUG	Efavaleukin alfa	Efavaleukin alfa administered as a subcutaneous injection.
DRUG	Placebo	Placebo administered as a subcutaneous injection.

Timeline

• Start date: 2018-05-22
• Primary completion: 2019-12-10
• Completion: 2020-05-13
• First posted: 2018-01-25
• Last updated: 2021-06-22
• Results posted: 2021-06-04

Locations

15 sites across 5 countries: United States, Bulgaria, Germany, Poland, Spain

Regulatory

• FDA-regulated drug study