Imagine waking up every day with a condition that makes your body attack itself. That's the reality for many people with systemic lupus erythematosus (SLE), a complex autoimmune disease that can cause fatigue, joint pain, and serious organ problems. Even with standard treatments, some patients still suffer from debilitating symptoms. That's where anifrolumab comes in. This new subcutaneous treatment is being tested in a large study to see if it can provide better relief for those with moderate to severe lupus who aren't responding well to current therapies. In this study, around 360 participants will receive either anifrolumab or a placebo, and researchers will closely monitor their responses. If anifrolumab proves effective, it could offer hope to countless individuals struggling to manage their lupus. However, it's important to remember that not every treatment works for everyone, and we still need to see the final results of this study. For now, this research represents a step forward in the fight against lupus, and it could pave the way for more effective treatments in the future.
Could a New Treatment Offer Hope for Patients with Lupus?
Plain Language Summary
What this means for you:
A new treatment for lupus could bring hope to those struggling with uncontrolled symptoms and improve their quality of life. What this means for you:
A new treatment for lupus could bring hope to those struggling with uncontrolled symptoms and improve their quality of life. View Original Abstract ↓
Status: ACTIVE_NOT_RECRUITING | Phase: PHASE3
Condition(s): Systemic Lupus Erythematosus
Intervention(s): Medi-546 (DRUG), Placebo (DRUG)
The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy
Detailed: This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of a subcutaneous treatment regimen of anifrolumab versus placebo in participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment. Participants must be taking either 1 or any combination of the following: oral glucocorticoids, antimalarial, and/or immunosuppressants. The study will be performed in adult participants of 18 to 70 years of age.
Approximately 360 participants receiving SOC treatment will be randomised in a 1:1 ratio to receive a fixed subcutaneous dose of anifrolumab or placebo administered once weekly via an accessorized prefilled syringe and with the
Primary Outcome(s): British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response
Enrollment: 367 (ACTUAL)
Lead Sponsor: AstraZeneca
Start: 2021-06-08 | Primary Completion: 2025-08-22