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

NCT06440525 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2025-07-18

No results posted yet for this 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

  • Primary Sjögren Syndrome

Interventions

DRUG

RSLV-132

Fc fusion protein comprised of catalytically active human ribonuclease (RNase) fused to human immunoglobulin G1 (IgG1)

DRUG

Placebo

0.9% sodium chloride solution

Sponsors & Collaborators

  • Resolve Therapeutics

    lead INDUSTRY

Principal Investigators

  • James Posada · Resolve Therapeutics LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-12-01
Completion
2027-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06440525 on ClinicalTrials.gov