Institutional Review Board, Hospital for Special Surgery
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
David R. Fernandez, MD, PhD
The purpose of this study is to evaluate safe and efficacious doses of AMG 570 for active Systemic Lupus Erythematosus (SLE) in patients who are not responding to the current standard of care. AMG 570 is an antibody designed to bind to both ICOSL and BAFF, two molecules involved in the immune response. Preliminary nonclinical studies have shown that there is potential for the dual-target treatment with AMG 570 to be a successful treatment for autoantibody associated diseases such as SLE. AMG 570 could be a viable treatment option for patients with active SLE who are not responding to current standard of care.
Approximately 300 patients will be enrolled into this study worldwide, about 2 of which will be at Hospital for Special Surgery. Study subjects who meet the study requirements and are enrolled will be randomized to receive either placebo or 1 of 3 dosages of AMG 570 with the last dose at week 50. Treatment will be administered every 2 weeks subcutaneously. Study duration for a single subject will be 52 weeks plus a screening period and a 16-week safety follow-up period. The research staff will provide a schedule of assessments that illustrates when study subjects will be expected to attend study visits.
Inclusion Criteria (someone can participate in the study if they meet all of the following)
• 18-75 years of age, inclusive, and able to provide informed consent
• SLE fulfilling 2019 EULAR/ACR criteria (including +ANA at screening and ≥ 10 points)
• Hybrid SLEDAI ≥ 6 with Clinical ≥ 4
• Taking 1 or 2 of these for SLE for ≥12 weeks and on a stable dosage of these medications for ≥ 8 weeks prior to screening
• HCQ, quinacrine, chloroquine, methotrexate, azathioprine, mycophenolate mofetil (i.e. Cellcept), dapsone
• If taking 2 of these, 1 of them must be either HCQ, Quinacrine, or chloroquine
• ≤ 20 mg/day prednisone or other equivalent oral corticosteroid, stable ≥ 2 weeks prior to screening visit
Exclusion Criteria (someone cannot participate in the study if they meet any of the following)
• Lupus nephritis requiring induction therapy within 1 year OR active LN with uPCR ≥ 3000 mg/g
• Active CNS lupus within 1 year (aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.)
• Another medical condition that may confound SLE disease assessment and/or that requires treatment with corticosteroids (APS is OK if no history of thrombotic events)
• Other non SLE disease that required corticosteroids for ≥ 2 weeks within 4 months
• Infections, including:
• Active TB OR latent TB without history of adequate treatment
• Hepatitis B or C infection
• HIV infection
• Other active infection
• Any cancer, except: resolved skin, cervical, or colon polyps > 5 years of screening
• Medication therapy as follows: