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A Study of RSLV-132 for Sjögren's Disease

This study is looking for women aged 18 to 75 with primary Sjögren's Syndrome (pSS) to test a drug called RSLV-132. You must have been diagnosed with pSS within the last 30 years, meet specific classification criteria, and have a positive anti-Ro/SSA antibody test. The main goal is to see if RSLV-132 can improve common Sjögren's symptoms like fatigue, dryness, and pain, and to understand its safety. Researchers will compare RSLV-132 to a placebo (an inactive substance) to determine its effects. The study aims to enroll 106 participants.

Study design
This study will compare RSLV-132 to a placebo in 106 women with Sjögren's Disease. The phase of the study is not specified.
What's involved
You would be assessed daily for Sjögren's symptoms starting at least 7 days before your first dose and continuing for 169 days after your first dose.
Compensation
Not stated in the trial record.
Follow-up
Your cardinal symptoms of Sjögren's will be assessed daily for 169 days after your first dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06440525

A Study of RSLV-132 in Females With Sjögren's Disease

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Resolve Therapeutics
~106 participants
Updated 2025-07-18 on ClinicalTrials.gov
What's tested:RSLV-132Placebo

At a glance

Recruiting sites
24 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of cardinal symptoms of Sjogren's
Measured over Measured daily from at least 7 days prior to first dose until 169 days after the first dose

Conditions

Primary Sjögren Syndrome

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Where it's being run

24 sites across 12 states
Florida6
Texas5
North Carolina3
California2
Illinois1
Iowa1
Massachusetts1
New Mexico1

Study leadership

  • James Posada · STUDY_DIRECTOR · Resolve Therapeutics LLC

Who to contact

PatientWing https://app.patientwing.com/campaign/clinicaltrials.gov
[email protected]
(213) 459-2979
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Providing written informed consent
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

Diagnosis of any active autoimmune disease other than pSS that could affect the efficacy assessments
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

What this trial measures

  • Assessment of cardinal symptoms of Sjogren'sMeasured daily from at least 7 days prior to first dose until 169 days after the first dose

    Change from baseline in Sjogren's symptoms on Day 169 assessed using the Sjogren's Symptom Activity Patient Reported Outcome (SSA-PRO) instrument