A Study of RSLV-132 in Females With Sjögren's Disease
Public ClinicalTrials.gov record NCT06440525. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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: * 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
Study identification
- NCT ID
- NCT06440525
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 106 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2024
- Primary completion
- Nov 30, 2026
- Completion
- Feb 28, 2027
- Last update posted
- Jul 17, 2025
2024 – 2027
United States locations
- U.S. sites
- 24
- U.S. states
- 12
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Resolve Clinical Site | Chula Vista | California | 91910 | Recruiting |
| Resolve Clinical Site | Tustin | California | 92780 | Recruiting |
| Resolve Clinical Site | Boca Raton | Florida | 34994 | Recruiting |
| Resolve Clinical Site | Boynton Beach | Florida | 33467 | Recruiting |
| Evolution Research Center | Hialeah | Florida | 33024 | Recruiting |
| GNP Research | Hollywood | Florida | 33024 | Recruiting |
| Resolve Clinical Site | Miami | Florida | 33140 | Recruiting |
| Life Medical Research | Miami Gardens | Florida | 33014 | Recruiting |
| Resolve Clinical Site | Chicago | Illinois | 60607 | Recruiting |
| University of Iowa | Iowa City | Iowa | 52242 | Recruiting |
| Tufts College | Boston | Massachusetts | 02111-1817 | Recruiting |
| Resolve Clinical Site | Albuquerque | New Mexico | 87106 | Recruiting |
| Joint and Muscle Research Institute | Charlotte | North Carolina | 28204 | Recruiting |
| Arthritis and Osteoporosis Consultants of the Carolinas | Charlotte | North Carolina | 28208 | Recruiting |
| Onsite Clinical Solutions | Salisbury | North Carolina | 28277 | Recruiting |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | Recruiting |
| Resolve Clinical Site | Nashville | Tennessee | 37203 | Recruiting |
| Resolve Clinical Site | Austin | Texas | 78757 | Recruiting |
| Resolve Clinical Site | Katy | Texas | 77449 | Recruiting |
| Resolve Clinical Site | McKinney | Texas | 75069 | Recruiting |
| Accurate Clinical Research | Richmond | Texas | 77089 | Recruiting |
| Resolve Clinical Site | San Antonio | Texas | 78215 | Recruiting |
| Metrodora Institute | Salt Lake City | Utah | 84119 | Recruiting |
| Arthritis Northwest | Spokane | Washington | 99204 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06440525, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 17, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06440525 live on ClinicalTrials.gov.