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

Last updated: April 19, 2025
Sponsor: Resolve Therapeutics
Overall Status: Active - Recruiting

Phase

2

Condition

Sjogren's Syndrome

Dermatomyositis (Connective Tissue Disease)

Treatment

Placebo

RSLV-132

Clinical Study ID

NCT06440525
132-6
  • Ages 18-65
  • Female

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Providing written informed consent

  • Weight at least 45 kg

  • Meet the 2016 American College of Rheumatology (ACR)/European League AgainstRheumatism (EULAR) Classification Criteria for pSS

  • Diagnosis in the last 10 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 highlyeffective contraceptive measures

Exclusion

Exclusion Criteria:

  • Diagnosis of any active autoimmune disease other than pSS that could affect theefficacy 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 Design

Total Participants: 106
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 01, 2024
Estimated Completion Date:
July 01, 2026

Connect with a study center

  • Resolve Clinical Site

    Chula Vista, California 91910
    United States

    Active - Recruiting

  • Resolve Clinical Site

    Napa, California 94558
    United States

    Active - Recruiting

  • Advanced Clinical Research Center

    San Diego, California 92108
    United States

    Site Not Available

  • Resolve Clinical Site

    Santa Clarita, California 91350
    United States

    Site Not Available

  • Resolve Clinical Site

    Boca Raton, Florida 34994
    United States

    Active - Recruiting

  • Resolve Clinical Site

    Boynton Beach, Florida 33467
    United States

    Active - Recruiting

  • Evolution Research Center

    Hialeah, Florida 33024
    United States

    Active - Recruiting

  • GNP Research

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • Resolve Clinical Site

    Miami, Florida 33140
    United States

    Active - Recruiting

  • Life Medical Research

    Miami Gardens, Florida 33014
    United States

    Active - Recruiting

  • Sarasota Arthritis Research Center

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Resolve Clinical Site

    Chicago, Illinois 60607
    United States

    Active - Recruiting

  • Tufts College

    Boston, Massachusetts 02111-1817
    United States

    Active - Recruiting

  • Resolve Clinical Site

    Albuquerque, New Mexico 87106
    United States

    Active - Recruiting

  • Arthritis and Osteoporosis Consultants of the Carolinas

    Charlotte, North Carolina 28208
    United States

    Active - Recruiting

  • Joint and Muscle Research Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Onsite Clinical Solutions

    Salisbury, North Carolina 28277
    United States

    Active - Recruiting

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • M3 Wake Research

    Chatanooga, Tennessee 27615
    United States

    Site Not Available

  • Accurate Clinical Research

    Houston, Texas 77089
    United States

    Site Not Available

  • Resolve Clinical Site

    Katy, Texas 77449
    United States

    Active - Recruiting

  • Resolve Clinical Site

    McKinney, Texas 75069
    United States

    Active - Recruiting

  • Accurate Clinical Research

    Richmond, Texas 77089
    United States

    Active - Recruiting

  • Resolve Clinical Site

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • Metrodora Institute

    Salt Lake City, Utah 84119
    United States

    Active - Recruiting

  • Arthritis Northwest

    Spokane, Washington 99204
    United States

    Active - Recruiting

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