[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Resolve Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100549935","phase-2-a-study-of-rslv-132-in-females-with-sjgrens-disease-100549935",false,"NCT06440525","A Study of RSLV-132 in Females With Sjögren's Disease","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Impact of Intravenous RSLV-132 in Participants With Sjögren's Disease With Moderate to Severe Symptom Burden","Inclusion Criteria:\n\n* Providing written informed consent\n* Weight at least 45 kg\n* Meet the 2016 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) Classification Criteria for pSS\n* Diagnosis in the last 30 years\n* Positive anti-Ro\u002FSSA antibody test\n* Score of 5 or higher on the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) scale and the ESSPRI fatigue scale\n* Of non childbearing potential or of childbearing potential and using highly effective contraceptive measures\n\nExclusion Criteria:\n\n* Diagnosis of any active autoimmune disease other than pSS that could affect the efficacy assessments\n* Uncontrolled hypothyroidism or severe fibromyalgia\n* New medications or change in medications in the last 4 weeks for pSS symptoms\n* Receipt of other prohibited medications\n* Apheresis or blood donation\n* Allergic reaction to RSLV-132 or biologic therapy\n* Clinically significant infection in last 30 days\n* Participation in another clinical study\n* Malignancy in last 5 years\n* Positive test for HIV or hepatitis\n* Major surgery in last 30 days or anticipated surgery during the study\n* Pregnancy or breast feeding\n* Laboratory blood tests outside of specified ranges\n* Other medical conditions or medications that would make the participant unsuitable","FEMALE","18 Years","75 Years",{"count":20,"type":21},106,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical study is to learn if RSLV-132 improves the symptoms of SS in adults. It will also learn about the safety of RSLV-132. The main questions it aims to answer are:\n\n* Does RSLV-132 improve the cardinal symptoms of Sjogren's including fatigue, dryness and pain?\n* Does RSLV-132 improve the tiredness\u002Ffatigue caused by Sjogren's?\n* What are the blood levels of RSLV-132 over time?\n* What is the immune (antibody) response in the body to RSLV-132?\n* What is the safety profile of RSLV-132?\n\nResearchers will compare RSLV-132 to a placebo (a look-alike substance that contains no drug) to see if RSLV-132 improves the symptoms of pSS.\n\nParticipants will:\n\nTake RSLV-132 or a placebo 13 times over 22 weeks Visit the clinic once every week for the first 2 weeks, then every 2 weeks until the end of treatment and then for a final time 4 weeks later (Day 211) for check-ups, tests and to answer questionnaires about their symptoms Record their symptoms every day on an electronic device",[27],"Primary Sjögren Syndrome","RECRUITING","2025-07-15",{"date":31,"type":32},"2025-07-18","ACTUAL",{"date":34,"type":32},"2024-12-01",{"date":36,"type":21},"2027-03-01",{"name":38,"class":39},"Resolve Therapeutics","INDUSTRY",24,""]