Scavenging IsoLGs in Autoimmune Disease: a Proof-of-concept Clinical Study
This is a phase II randomized, placebo-controlled, double-blind, cross-over study to determine the effect of isolevuglandin (IsoLG) scavenging by 2-HOBA on blood pressure and immune activation in patients with SLE. 42 patients with stable SLE will be randomized to treatment sequence to receive placebo or 500mg 2-HOBA three times a day for 8 weeks followed by a 4 week washout and then 8 weeks of the other agent. Primary outcome measures include change in 24-hour blood pressure and NETosis. This study will provide mechanistic information on the role of IsoLGs in autoimmune disease-associated hypertension and immune activation.
• Written informed consent
• Age ≥18 years
• Female (biological)
• Meeting the 2019 European League Against Rheumatism/ American College of Rheumatology classification criteria for SLE32
• No change in immunosuppressants ≥3 months
• Stable prednisone (or equivalent) dose ≤ 20mg/ day for ≥ 1 month
• Elevated blood pressure defined as \>120 and \< or = 160 mmHg systolic or \>80 and \< or = 110 mmHg diastolic blood pressure at screening visit
• No change in anti-hypertensive dose ≥2 weeks
• Willingness to stop NSAIDs for ≥2 weeks before and throughout the study
• If of childbearing potential, willingness to use effective birth control throughout the study and 4 weeks after completion of the study (examples: condom, diaphragm, oral contraceptive pill, intrauterine device)