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NCT Number: NCT06440525

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 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

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Key information

Conditions

Primary Sjögren Syndrome

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Resolve Clinical Site, Chula Vista, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RSLV-132

Drug

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

Placebo

Drug

0.9% sodium chloride solution

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. RSLV-132 immunogenicity

    Time frame: Measured from before the first dose until Day 211

    Presence of antibodies to RSLV-132 measured using an immunoassay

  4. Adverse events

    Time frame: From the first dose of Investigational Product until Day 211

    Incidence of serious and non-serious adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

PatientWing https://app.patientwing.com/campaign/clinicaltrials.gov

CONTACT

[email protected]

(213) 459-2979

Sponsors and collaborators

Lead sponsor

Resolve Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 4, 2024
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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