Testing AZD5492 for systemic lupus erythematosus

Inclusion

• +Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
• +Diagnosis of SLE:
• +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
• +Active, moderate-severe disease at screening, defined as clinical SLEDAI-2K ≥ 4.
• +Intolerance to, or inadequate response following at least 3 months of use to, ≥ 3 available treatments, such as the following: corticosteroids, anti-malarial drugs, calcineurin inhibitor, methotrexate, azathioprine, leflunomide, mycophenolic acid or its derivatives, cyclophosphamide, belimumab, anifrolumab, telitacicept, or B-cell depleting monoclonal antibodies.
• +Diagnosis of IIM:
• +Must have "probable" or "definite" diagnosis of PM or DM (excluding IBM and cancer associated myositis) according to the 2017 EULAR/ACR classification criteria for adult myositis.
• +Positive for ≥ 1 disease-specific autoantibody at screening.
• +MMT-8 score of ≤ 142/150 and/or CDASI-A ≥ 6
• +Fulfill at least one of the following criteria of active disease at screening:
• +(i) One or more muscle enzyme elevation (CK, AST, ALT, aldolase, LDH) ≥ 1.3 × ULN (ii) If criterion 3(d)(i) is not met, then at least one of the following criteria must be met: a. Report from MRI performed within 3 months prior to screening with evidence of muscle inflammation b. Report from muscle biopsy performed within 3 months prior to screening that demonstrates active inflammation c. Report from electromyography performed within 3 months prior to screening that exhibits irritable myopathic pattern.
• +(e) Intolerance or inadequate response to corticosteroids and ≥2 other SoCStandard of careThe treatment normally given for a condition outside a study.Read more → treatments, used for at least 3 months each, for which at least one must be a biologic SoC, immunoglobulin or cyclophosphamide.
• +Diagnosis of RA:
• +(a) Diagnosis of RA as defined by the 2010 EULAR/ACR classification criteria (b) Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory at screening: RF or ACPA (c) Moderate or severe disease activity defined as: (i) ≥6 tender joints and ≥6 swollen joints AND (ii) DAS28-CRP \>3.2. (d) Intolerance to or inadequate response following approximately 3 month's treatment or longer to ≥2 b/tsDMARDs (with different mechanisms of action) after failing csDMARD therapy (unless csDMARD therapy is contraindicated). There is no minimum duration for taking a treatment in cases of intolerance.