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NCT06440525 · ClinicalTrials.gov registry record · Phase 2
A Study of RSLV-132 in Females With Sjögren's Disease
A Phase 2 study of Primary Sjögren Syndrome, sponsored by Resolve Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 106
- Enrollment target
- 20
- Study locations
NCT06440525 is a Phase 2 study of Primary Sjögren Syndrome that is actively recruiting participants, run by Resolve Therapeutics. The registered enrollment target is 106 participants. The trial reports 20 study locations across 10 states.
The verdict
NCT06440525, a Phase 2 study of Primary Sjögren Syndrome, is actively recruiting participants, sponsored by Resolve Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 106 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG RSLV-132
Study Locations (20)
Florida
- Resolve Clinical Site - Boca Raton
- Resolve Clinical Site - Boynton Beach
- Evolution Research Center - Hialeah
- GNP Research - Hollywood
- Resolve Clinical Site - Miami
- Life Medical Research - Miami Gardens
North Carolina
- Joint and Muscle Research Institute - Charlotte
- Arthritis and Osteoporosis Consultants of the Carolinas - Charlotte
- Onsite Clinical Solutions - Salisbury
Texas
- Resolve Clinical Site - Austin
- Resolve Clinical Site - Katy
- Resolve Clinical Site - McKinney
California
- Resolve Clinical Site - Chula Vista
- Resolve Clinical Site - Tustin
Illinois
- Resolve Clinical Site - Chicago
Iowa
- University of Iowa - Iowa City
Massachusetts
- Tufts College - Boston
New Mexico
- Resolve Clinical Site - Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2024-12-01 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06440525
The ClinicalTrials.gov registry entry for NCT06440525 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Resolve Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Sjögren Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06440525 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT06440525 about?
NCT06440525 is a clinical study titled "A Study of RSLV-132 in Females With Sjögren's Disease". 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 i...
What is the current status of trial NCT06440525?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2024-12-01. Estimated completion is 2027-03-01.
What conditions does trial NCT06440525 study?
This clinical trial studies the following conditions: Primary Sjögren Syndrome.
What interventions are being tested in trial NCT06440525?
The interventions under investigation include: Placebo (DRUG), RSLV-132 (DRUG).
Who is sponsoring clinical trial NCT06440525?
This trial is sponsored by Resolve Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06440525 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Iowa, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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