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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSLV-132 | Experimental | 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 |
|
| Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSLV-132 | Drug | Fc fusion protein comprised of catalytically active human ribonuclease (RNase) fused to human immunoglobulin G1 (IgG1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of cardinal symptoms of Sjogren's | Change from baseline in Sjogren's symptoms on Day 169 assessed using the Sjogren's Symptom Activity Patient Reported Outcome (SSA-PRO) instrument | Measured daily from at least 7 days prior to first dose until 169 days after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Tiredness/fatigue assessment | Change from baseline in the Patient Reported Outcomes Measurement Information System Fatigue Short Form 10a (PROMIS SF10a) on Day 169 | Measured from before the first dose until Day 169 |
| RSLV-132 pharmacokinetics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PatientWing https://app.patientwing.com/campaign/clinicaltrials.gov | Contact | (213) 459-2979 | studies@patientwing.com |
| Name | Affiliation | Role |
|---|---|---|
| James Posada | Resolve Therapeutics LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Resolve Clinical Site | Recruiting | Chula Vista | California | 91910 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32798283 | Background | 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. | |
| 27785888 |
| Label | URL |
|---|---|
| Related Info | View source |
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| Placebo | Drug | 0.9% sodium chloride solution |
|
Serum concentrations of RSLV-132 using an assay measuring RNAse enzyme activity
| Measured from before the first dose until Day 211 |
| RSLV-132 immunogenicity | Presence of antibodies to RSLV-132 measured using an immunoassay | Measured from before the first dose until Day 211 |
| Adverse events | Incidence of serious and non-serious adverse events | From the first dose of Investigational Product until Day 211 |
| Resolve Clinical Site | Recruiting | Tustin | California | 92780 | United States |
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| Resolve Clinical Site | Recruiting | Boca Raton | Florida | 34994 | United States |
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| Resolve Clinical Site | Recruiting | Boynton Beach | Florida | 33467 | United States |
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| Evolution Research Center | Recruiting | Hialeah | Florida | 33024 | United States |
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| GNP Research | Recruiting | Hollywood | Florida | 33024 | United States |
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| Resolve Clinical Site | Recruiting | Miami | Florida | 33140 | United States |
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| Life Medical Research | Recruiting | Miami Gardens | Florida | 33014 | United States |
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| Resolve Clinical Site | Recruiting | Chicago | Illinois | 60607 | United States |
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| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| Tufts College | Recruiting | Boston | Massachusetts | 02111-1817 | United States |
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| Resolve Clinical Site | Recruiting | Albuquerque | New Mexico | 87106 | United States |
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| Joint and Muscle Research Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| Arthritis and Osteoporosis Consultants of the Carolinas | Recruiting | Charlotte | North Carolina | 28208 | United States |
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| Onsite Clinical Solutions | Recruiting | Salisbury | North Carolina | 28277 | United States |
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| Altoona Center for Clinical Research | Recruiting | Duncansville | Pennsylvania | 16635 | United States |
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| Resolve Clinical Site | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Resolve Clinical Site | Recruiting | Austin | Texas | 78757 | United States |
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| Resolve Clinical Site | Recruiting | Katy | Texas | 77449 | United States |
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| Resolve Clinical Site | Recruiting | McKinney | Texas | 75069 | United States |
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| Accurate Clinical Research | Recruiting | Richmond | Texas | 77089 | United States |
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| Resolve Clinical Site | Recruiting | San Antonio | Texas | 78215 | United States |
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| Metrodora Institute | Recruiting | Salt Lake City | Utah | 84119 | United States |
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| Arthritis Northwest | Recruiting | Spokane | Washington | 99204 | United States |
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| 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. |
| ID | Term |
|---|---|
| C000626691 | RSLV-132 |
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