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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: Recruiting Phase 2 study of Primary Sjögren Syndrome, sponsored by Resolve Therapeutics.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Change from baseline in Sjogren's symptoms on Day 169 assessed using the Sjogren's Symptom Activity Patient Reported Outcome (SSA-PRO) instrument
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 |
What NCT06440525 shows while recruiting
NCT06440525 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06440525's enrollment target sits among peer trials
106 648th of 2000 higher than 1,351 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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