Amgen Study 20200234

A clinical research study evaluating an investigational drug, efavaleukin alfa, in people with lupus who have continued disease activity despite current therapy.

Study Title:

A Phase 2b Dose Ranging Study to Evaluate the Efficacy and safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus (SLE) with Inadequate Response to Current Therapy

Sponsor Name:

Amgen Inc.

Purpose of Study:

Amgen is evaluating the safety and efficacy of an investigational drug, efavaleukin alfa (AMG 592), in people with systemic lupus erythematosus (SLE) who have continued disease activity despite current therapy. Efavaleukin alfa is being investigated as a potential treatment for systemic lupus erythematosus.

What Does this Study Involve?

• If you meet the clinical study requirements and are enrolled, you will be in this study for about 56 weeks (including the safety follow-up period) plus the screening period.
• Investigational drug will be administered on a regular schedule with the final dose at week 50. All participants in the study will be followed for safety for 6 weeks after the last dose of investigational drug.
• You must be available to visit the research facility on multiple occasions. Visits should be completed per study schedule until the end of the study. Additional visits may be added if needed. The research facility staff will provide you with a schedule for when you need to return to the clinical research facility.
• If you are found eligible, you may be randomized into 1 of 4 groups. Randomized means that you are put into a group by chance. It is like flipping a coin or drawing numbers out of a hat. You will have a 3 in 4 (75%) chance of receiving efavaleukin alfa, and 1 in 4 (25%) chance of receiving placebo. If you are receiving efavaleukin alfa, you will be assigned to 1 of 3 different doses.
• Participants receive all study-related procedures and the study medicine at no cost.

You May Qualify for This Study If You:

• Age ≥ 18 years to 75 years
• Have been diagnosed with SLE
• Continue to have active lupus despite taking at least one therapy for SLE

You must satisfy the eligibility criteria for the study to be enrolled. However, even if you satisfy the eligibility criteria, it is possible you might not be selected to enroll in the study for various reasons. Reasons may include if the study has been halted, the study has enrolled the maximum number of participants, or study drug is not available.

Study Type:

• 2b
• Dose Ranging (different doses will be tested)
• Adaptive Study Design

Learn More by visiting www.amgentrials.com/study/?id=20200234

Choosing to participate in a study is an important personal decision. Be sure to have an open  conversation with your doctor. It is important to understand all of your options before deciding what is right for you. Choosing to be in a clinical trial is voluntary. For more information about clinical trials, visit our Featured Research Studies page.