[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07225543":3,"trial-entities:NCT07225543":120,"trial-summary:NCT07225543":124},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":55,"secondary_outcomes":63,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":93,"locations":96,"central_contacts":111,"overall_officials":114,"references":118,"see_also_links":119},"NCT07225543","250944","2-HOBA in Systemic Lupus Erythematosus","Scavenging IsoLGs in Autoimmune Disease: a Proof-of-concept Clinical Study","RECRUITING","2030-07-31","2026-05","2026-05-22","2026-05-15","Vanderbilt University Medical Center","OTHER",true,"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.\n\nPrimary 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.","Systemic lupus erythematosus (SLE) is an inflammatory autoimmune disease with a markedly increased prevalence of not only hypertension but also resistant hypertension. Hypertension, along with other factors, leads to a 2 to 3-fold increase in risk of cardiovascular disease in SLE. Other than glucocorticoids and immunosuppression, there are few therapeutic options for patients with SLE and none that are known to have a beneficial effect on hypertension and cardiovascular disease; in fact, glucocorticoids have substantial deleterious effects. The increased prevalence of hypertension and its greater severity in SLE patients are unexplained; however, work from our group and others increasingly implicates activation of the immune system in the pathogenesis of hypertension. Moreover, our data suggest that downstream products of oxidative stress, specifically isolevuglandins (IsoLGs), drive immune activation and hypertension.\n\nIsoLGs are highly reactive dicarbonyl products of oxidative stress that bind covalently to proteins causing conformational changes rendering them immunogenic and proinflammatory. Two decades of work at Vanderbilt led to the identification of 2-hydroxybenzylamine (2-HOBA) as a highly effective scavenger of reactive dicarbonyls such as IsoLGs. Scavenging reactive dicarbonyls is preferable to using antioxidants because reactive oxygen species are necessary for normal cellular function. In animal models of SLE, hypertension, and atherosclerosis 2-HOBA reduced inflammation, neutrophil extracellular traps (NETosis), blood pressure, and atherosclerosis, and in human phase I clinical studies with healthy volunteers it was well tolerated.\n\nThis is a mechanistic, proof-of-concept phase II study with a randomized, placebo-controlled, double-blind, cross-over design to determine the effect of 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. Comparing 2-HOBA and placebo arms, primary outcomes include change in 24-hour blood pressure and immune activation measured by NETosis.",[19],"Systemic Lupus Erthematosus (SLE)",[21,22,23,24,25,26,27,28],"systemic lupus erythematosus","SLE","lupus","oxidative stress","hypertension","blood pressure","NETosis","isolevuglandins","INTERVENTIONAL","TREATMENT",[32],"PHASE2",{"count":34,"type":35},42,"ESTIMATED",[37,49],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":44},"DRUG","2-HOBA acetate (2-Hydroxybenzlamine acetate)","2-HOBA acetate (2-Hydroxybenzlamine acetate) 500mg (provided as two 250mg capsules) three times per day",[42,43],"2-HOBA First","Placebo First",[45,46,47,48],"2-hydroxybenzylamine","2-HOBA","salicylamine","IUPAC name: 2-(aminomethyl)phenol",{"type":38,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Placebo","Placebo (provided as two capsules) three times per day",[42,43],[54],"indentical placebo",[56,60],{"measure":57,"description":58,"timeFrame":59},"24-hour systolic blood pressure","Investigators will measure change in 24-hour systolic blood pressure","Measured at the beginning and end of each phase at weeks 0, 8, 12, and 20.",{"measure":27,"description":61,"timeFrame":62},"Investigators will measure change in NETosis by ELISA assessing circulating NET concentration","Measured at beginning and end of each phase at weeks 0, 8, 12, and 20.",[],"FEMALE","18 Years",null,false,{"inclusion":69,"exclusion":80,"raw_text":92},[70,71,72,73,74,75,76,77,78,79],"Written informed consent","Age ≥18 years","Female (biological)","Meeting the 2019 European League Against Rheumatism\u002F American College of Rheumatology classification criteria for SLE32","No change in immunosuppressants ≥3 months","Stable prednisone (or equivalent) dose ≤ 20mg\u002F day for ≥ 1 month","Elevated blood pressure defined as \\>120 and \\\u003C or = 160 mmHg systolic or \\>80 and \\\u003C 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)",[81,82,83,84,85,86,87,88,89,90,91],"Pregnant or breastfeeding","Male (biological)","Active cancer except for non-melanoma skin cancer","Prior diagnosis of liver cirrhosis or the following abnormal liver function studies: AST or ALT \\>1.5x the upper limit of normal or total bilirubin ≥1.5 mg\u002Fdl","Active infection requiring medical intervention","Major surgery in ≤ 3 months","Aspirin allergy","Use of MAO-I","Estimated creatinine clearance \\\u003C30 ml\u002Fmin","Known atrial fibrillation","Severe comorbid condition","Inclusion Criteria:\n\n* Written informed consent\n* Age ≥18 years\n* Female (biological)\n* Meeting the 2019 European League Against Rheumatism\u002F American College of Rheumatology classification criteria for SLE32\n* No change in immunosuppressants ≥3 months\n* Stable prednisone (or equivalent) dose ≤ 20mg\u002F day for ≥ 1 month\n* Elevated blood pressure defined as \\>120 and \\\u003C or = 160 mmHg systolic or \\>80 and \\\u003C or = 110 mmHg diastolic blood pressure at screening visit\n* No change in anti-hypertensive dose ≥2 weeks\n* Willingness to stop NSAIDs for ≥2 weeks before and throughout the study\n* 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)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Male (biological)\n* Active cancer except for non-melanoma skin cancer\n* Prior diagnosis of liver cirrhosis or the following abnormal liver function studies: AST or ALT \\>1.5x the upper limit of normal or total bilirubin ≥1.5 mg\u002Fdl\n* Active infection requiring medical intervention\n* Major surgery in ≤ 3 months\n* Aspirin allergy\n* Use of MAO-I\n* Estimated creatinine clearance \\\u003C30 ml\u002Fmin\n* Known atrial fibrillation\n* Severe comorbid condition",[94,95],"ADULT","OLDER_ADULT",[97],{"facility":13,"status":8,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":108},"Nashville","Tennessee","37232","United States",[103],{"name":104,"role":105,"phone":106,"email":107},"Phicharmon Kulapatana","CONTACT","615-936-5747","phicharmon.kulapatana@vumc.org",{"lat":109,"lon":110},36.16589,-86.78444,[112],{"name":113,"role":105,"phone":106,"email":107},"Phicharmon Kulapatana (study coordinator)",[115],{"name":116,"affiliation":13,"role":117},"Michelle J Ormseth, MD, MSCI","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":121,"biomarkers":123},[122],"Systemic Lupus Erythematosus",[],{"nct_id":4,"found":15,"summary":125,"prompt_version":135},{"design":126,"status":127,"heading":128,"summary":129,"follow_up":130,"word_count":131,"commitments":132,"compensation":133,"drugs_mentioned":134},"This is a randomized, placebo-controlled, double-blind, cross-over study involving 42 participants. This means participants will be randomly assigned to receive either 2-HOBA acetate or a placebo, and neither you nor your doctor will know which you are receiving.","completed","2-HOBA for Systemic Lupus Erythematosus","This study is looking at how a drug called 2-HOBA acetate affects blood pressure and immune system activity in people with Systemic Lupus Erythematosus (SLE), an autoimmune disease. Researchers believe that certain byproducts of stress in the body, called isolevuglandins (IsoLGs), might contribute to high blood pressure and immune problems in SLE. 2-HOBA acetate is thought to help by removing these IsoLGs. You might be able to join if you are a woman, at least 18 years old, have stable SLE, and have elevated blood pressure. The study will measure changes in your 24-hour blood pressure and NETosis (a type of immune cell activity) to see if 2-HOBA acetate is helpful. The current status of this study is unclear.","Participants will be followed for 20 weeks, which includes the treatment phases and a washout period.",119,"Participants will take two capsules of either 2-HOBA acetate or placebo three times a day for 8 weeks, followed by a 4-week break, and then 8 weeks of the other agent. Blood pressure and NETosis will be measured at the beginning and end of each phase (weeks 0, 8, 12, and 20).","Not stated in the trial record.",[],"v2"]