A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects with Active Systemic Lupus Erythematosus (SLE) with Inadequate Response to Standard of Care (SOC) Therapy

Modification #2 Feb 15, 2021: Title of protocol changed and phase changed from phase 2 to phase 2b. Changes in timing of selected activities, addition of labs (ESR, coagulation tests), the PRO sub-study and a COVID related consent for remote monitoring. IB updated to Edition 5. Modification #1 May 2020: Study visits were reduced from 33 to 32 visits. One screening visit was removed. A homecare option was added. The Penn site will not use homecare. A 4th optional sub-study, 'Lupus Symptom Questionnaire', was added. The modification revised some of the risks. Initial submission. This is a double-blind, randomized, placebo-controlled, multicenter, phase 2 dose-ranging study to evaluate the efficacy and safety of AMG 570 in subjects with active SLE who are not responding to standard of care. Subjects will be randomized to receive either placebo or 1 of 3 doses of AMG 570 by sc injection every 2 weeks, with the last dose at Week 50. Study duration for a single subject will be 52 weeks plus the screening period and required 16 weeks safety follow-up period consisting of 4 visits. There are 33 total visits. Target enrollment: 300 people, about 80 sites. Key eligibility criteria: Between 18-75 years old; must meet SLICC criteria for SLE; taking standard SLE trx; Sledai-2k score greater than/equal to 4. Procedures: Medical/meds hx, PE's, physical measures, vital signs, TB/HIV testing, blood, urine, pregnancy tests, PKs, specialty labs, safety/disease assessments, photography, 3 optional sub-studies, including genetic testing.