Summary:
Click image to enlargeAmgen Inc. / “A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy”
This study will help determine if AMG 570 could be a useful therapeutic agent in the current treatment landscape where subjects have ongoing disease activity despite treatment with standard of care therapies. Current treatment options include antimalarials, corticosteroids, and other immunomodulators/immunosuppressants, and few biologics (including Benlysta), which have limited efficacy and may have toxicities that impede a patient’s ability to remain on therapy. Therefore, significant need exists for effective therapies with limited toxicities.
- Be 18 to 75 years old
- Have confirmed, active SLE
- Must be taking at least one but not more than two of the following SLE treatments: mycophenolate mofetil, azathioprine, methotrexate, hydroxychloroquine, chloroquine, dapsone, or quinacrine
- For subjects taking oral corticosteroids, the dose must be ≤ 20 mg/day of prednisone or equivalent
- No history of lupus nephritis requiring induction therapy within 1 year prior to screening or urine protein:creatinine ratio to ≥ 3000mg/g at baseline
- History of active CNS lupus within 1 year prior to screening including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis
Qualified Participants May Receive:
$45 per visit for a possible $1,260 total.