Summary:
If you have been diagnosed with Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN), you may be able to take part in a clinical research study.
Study Purpose:
The purpose of the RestoreD Study is to evaluate the safety and effectiveness of an oral investigational medication, called ALXN2050, compared with placebo in reducing symptoms in adults with LN or IgAN. The RestoreD Study is evaluating if the investigational medication may help inhibit factor D, which contributes to LN and IgAN, and is establishing a dose level of the investigational medication in people with LN or IgAN. The investigational medication and the placebo will be administered as oral tablets taken twice daily while continuing to receive standard-of-care management for your condition.
All participants who qualify will receive the investigational medication or a placebo, as well as study-related exams and study-related laboratory tests, at no cost. Reimbursement for time and travel may also be available.
Eligibility Criteria:
Eligible participants must:
- Be between 18 and 75 years of age
- Have proteinuria (high levels of protein in their urine)
- Have a confirmed diagnosis of LN (a form of systemic lupus erythematosus [SLE]) or primary IgAN. Participants with LN must have an active renal flare.
- For IgAN participants: be on a stable dose of renin–angiotensin system (RAS) inhibitor treatment that includes one of the following for at least three months:
- An angiotensin-converting enzyme (ACE) inhibitor
OR
- An angiotensin II receptor blocker (ARB) dose
Other protocol-defined inclusion and exclusion criteria may apply.