Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
106 participants
INTERVENTIONAL
2024-12-01
2027-03-01
Brief Summary
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* Does RSLV-132 improve the cardinal symptoms of Sjogren's including fatigue, dryness and pain?
* Does RSLV-132 improve the tiredness/fatigue caused by Sjogren's?
* What are the blood levels of RSLV-132 over time?
* What is the immune (antibody) response in the body to RSLV-132?
* What is the safety profile of RSLV-132?
Researchers 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.
Participants will:
Take 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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RSLV-132
Intravenous infusions of 10 mg/kg RSLV-132 solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155) for a total of 22 weeks of treatment
RSLV-132
Fc fusion protein comprised of catalytically active human ribonuclease (RNase) fused to human immunoglobulin G1 (IgG1)
Placebo
Intravenous infusions of placebo solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155) for a total of 22 weeks of treatment
Placebo
0.9% sodium chloride solution
Interventions
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RSLV-132
Fc fusion protein comprised of catalytically active human ribonuclease (RNase) fused to human immunoglobulin G1 (IgG1)
Placebo
0.9% sodium chloride solution
Eligibility Criteria
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Inclusion Criteria
* Weight at least 45 kg
* Meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for pSS
* Diagnosis in the last 30 years
* Positive anti-Ro/SSA antibody test
* Score of 5 or higher on the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) scale and the ESSPRI fatigue scale
* Of non childbearing potential or of childbearing potential and using highly effective contraceptive measures
Exclusion Criteria
* Uncontrolled hypothyroidism or severe fibromyalgia
* New medications or change in medications in the last 4 weeks for pSS symptoms
* Receipt of other prohibited medications
* Apheresis or blood donation
* Allergic reaction to RSLV-132 or biologic therapy
* Clinically significant infection in last 30 days
* Participation in another clinical study
* Malignancy in last 5 years
* Positive test for HIV or hepatitis
* Major surgery in last 30 days or anticipated surgery during the study
* Pregnancy or breast feeding
* Laboratory blood tests outside of specified ranges
* Other medical conditions or medications that would make the participant unsuitable
18 Years
75 Years
FEMALE
No
Sponsors
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Resolve Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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James Posada
Role: STUDY_DIRECTOR
Resolve Therapeutics LLC
Locations
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Resolve Clinical Site
Chula Vista, California, United States
Resolve Clinical Site
Tustin, California, United States
Resolve Clinical Site
Boca Raton, Florida, United States
Resolve Clinical Site
Boynton Beach, Florida, United States
Evolution Research Center
Hialeah, Florida, United States
GNP Research
Hollywood, Florida, United States
Resolve Clinical Site
Miami, Florida, United States
Life Medical Research
Miami Gardens, Florida, United States
Resolve Clinical Site
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Tufts College
Boston, Massachusetts, United States
Resolve Clinical Site
Albuquerque, New Mexico, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, United States
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, United States
Onsite Clinical Solutions
Salisbury, North Carolina, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Resolve Clinical Site
Nashville, Tennessee, United States
Resolve Clinical Site
Austin, Texas, United States
Resolve Clinical Site
Katy, Texas, United States
Resolve Clinical Site
McKinney, Texas, United States
Accurate Clinical Research
Richmond, Texas, United States
Resolve Clinical Site
San Antonio, Texas, United States
Metrodora Institute
Salt Lake City, Utah, United States
Arthritis Northwest
Spokane, Washington, United States
Countries
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Central Contacts
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PatientWing https://app.patientwing.com/campaign/clinicaltrials.gov
Role: CONTACT
Facility Contacts
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References
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Posada J, Valadkhan S, Burge D, Davies K, Tarn J, Casement J, Jobling K, Gallagher P, Wilson D, Barone F, Fisher BA, Ng WF. Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjogren's Syndrome: A Randomized Clinical Trial. Arthritis Rheumatol. 2021 Jan;73(1):143-150. doi: 10.1002/art.41489. Epub 2020 Nov 22.
Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts. Arthritis Rheumatol. 2017 Jan;69(1):35-45. doi: 10.1002/art.39859. Epub 2016 Oct 26.
Related Links
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Other Identifiers
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132-6
Identifier Type: -
Identifier Source: org_study_id
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