Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
Trial Summary
What is the purpose of this trial?
This trial is testing Rozibafusp Alfa to see if it can help patients with active SLE who haven't improved with standard treatments. The medication works by calming the overactive immune system. Rozibafusp Alfa is a new treatment being tested for systemic lupus erythematosus (SLE).
Will I have to stop taking my current medications?
The trial requires that you continue taking certain SLE treatments, such as anti-malarials or other specified medications, for at least 12 weeks before screening and maintain a stable dose for at least 8 weeks. If you're on oral corticosteroids, the dose must be stable and not exceed 20 mg/day of prednisone or its equivalent.
What data supports the effectiveness of the drug Rozibafusp Alfa?
Rozibafusp Alfa has shown effectiveness in reducing certain immune cells in patients with rheumatoid arthritis, which suggests it may help in conditions involving the immune system. It works by targeting specific proteins that play a role in immune responses, and this mechanism has been studied in early clinical trials.12345
How is the drug Rozibafusp Alfa different from other treatments for autoimmune conditions?
Rozibafusp Alfa is unique because it is a first-in-class bispecific inhibitor that targets both the inducible T-cell costimulator ligand (ICOSL) and B-cell activating factor (BAFF), which are involved in immune system regulation. This dual-target approach is different from other treatments that typically focus on a single pathway, potentially offering a more comprehensive modulation of the immune response.12678
Research Team
MD
Principal Investigator
Amgen
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Rozibafusp Alfa or placebo in a double-blind, randomized, placebo-controlled setting for dose-ranging over 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Rozibafusp Alfa
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London