NCT03451422

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus

A Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Multiple Ascending Subcutaneous Doses of Efavaleukin Alfa in Subjects With Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE).

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Efavaleukin Alfa	Efavaleukin Alfa will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm.
DRUG	Placebo	The placebo will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm.

Timeline

• Start date: 2018-04-10
• Primary completion: 2021-10-12
• Completion: 2021-10-12
• First posted: 2018-03-01
• Last updated: 2023-07-19
• Results posted: 2023-07-19

Locations

15 sites across 4 countries: United States, France, Germany, Poland

Regulatory

• FDA-regulated drug study