The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA
Study details include:
• The study duration will be a minimum of 180 days in addition to the screening period.
Additional follow-up visits may be required up to 12 months from study start.
* Depending on the study part they are assigned to, participants will be administered AZD5492 once (Part 1) or twice (Part 2). * Study visits will occur at:
Screening, Days 1-4, 8, 15, 22, 30, 60, 90, 120, 150, and 180 in Part 1, Screening, Days 1-4, 8-11, 15, 22, 29, 43, 60, 90, 120, 150, and 180 in Part 2.
Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria for SLE
Positive for one or more of: anti-nuclear antibodies (titre ≥ 1:80), anti-dsDNA or anti-Sm at screening.
Active, moderate-severe disease at screening, defined as clinical SLEDAI-2K ≥ 4.
Active severe SLE-driven renal disease.
History of, or current diagnosis of, catastrophic or severe APS (for example diagnosis of an arterial or central/pulmonary venous clot) within 1 year prior to signing the ICF.
Rapidly progressive and/or severe ILD or ILD that requires oxygen supplementation/therapy (of any type).
Inclusion Body Myositis or cancer associated myositis.
AstraZeneca
Lead sponsor
Fortrea
Collaborator