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

July 15, 2025 updated by: Resolve Therapeutics

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: PatientWing https://app.patientwing.com/campaign/clinicaltrials.gov
  • Phone Number: (213) 459-2979
  • Email: studies@patientwing.com

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91910
      • Tustin, California, United States, 92780
    • Florida
    • Illinois
    • Iowa
    • Massachusetts
      • Boston, Massachusetts, United States, 02111-1817
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
      • Charlotte, North Carolina, United States, 28208
      • Salisbury, North Carolina, United States, 28277
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
    • Utah
      • Salt Lake City, Utah, United States, 84119
    • Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RSLV-132
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
Drug: RSLV-132
Fc fusion protein comprised of catalytically active human ribonuclease (RNase) fused to human immunoglobulin G1 (IgG1)
Placebo Comparator: Placebo
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
Drug: Placebo
0.9% sodium chloride solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of cardinal symptoms of Sjogren's
Time Frame: Measured 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
Measured daily from at least 7 days prior to first dose until 169 days after the first dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tiredness/fatigue assessment
Time Frame: Measured from before the first dose until Day 169
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
Time Frame: Measured from before the first dose until Day 211
Serum concentrations of RSLV-132 using an assay measuring RNAse enzyme activity
Measured from before the first dose until Day 211
RSLV-132 immunogenicity
Time Frame: Measured from before the first dose until Day 211
Presence of antibodies to RSLV-132 measured using an immunoassay
Measured from before the first dose until Day 211
Adverse events
Time Frame: From the first dose of Investigational Product until Day 211
Incidence of serious and non-serious adverse events
From the first dose of Investigational Product until Day 211

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Resolve Therapeutics

Investigators

  • Study Director: James Posada, Resolve Therapeutics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 132-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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