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NCT06440525 | RECRUITING | Primary Sjögren Syndrome

A Study of RSLV-132 in Females with Primary Sjögren's Syndrome
Sponsor:

Resolve Therapeutics

Brief Summary:

The goal of this clinical study is to learn if RSLV-132 improves the symptoms of pSS 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

Condition or disease

Primary Sjogren's Syndrome

Intervention/treatment

RSLV-132

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 106 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Impact of Intravenous RSLV-132 in Participants with Primary Sjögren's Syndrome (pSS) with Moderate to Severe Symptom Burden
Actual Study Start Date : 2024-09-01
Estimated Primary Completion Date : 2026-05-01
Estimated Study Completion Date : 2026-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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 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 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
A Study of RSLV-132 in Females with Primary Sjögren's Syndrome

Location Details

NCT06440525

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How to Participate

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Locations

RECRUITING

United States, California

Advanced Clinical Research Center

San Diego, California, United States, 92108

RECRUITING

United States, Florida

Evolution Research Center

Hialeah, Florida, United States, 33024

RECRUITING

United States, Florida

GNP Research

Hollywood, Florida, United States, 33024

RECRUITING

United States, Florida

Life Medical Research

Miami Gardens, Florida, United States, 33014

RECRUITING

United States, Florida

Sarasota Arthritis Research Center

Sarasota, Florida, United States, 34239

RECRUITING

United States, Massachusetts

Tufts College

Boston, Massachusetts, United States, 02111-1817

RECRUITING

United States, North Carolina

Joint and Muscle Research Institute

Charlotte, North Carolina, United States, 28204

RECRUITING

United States, North Carolina

Arthritis and Osteoporosis Consultants of the Carolinas

Charlotte, North Carolina, United States, 28208

RECRUITING

United States, North Carolina

Onsite Clinical Solutions

Salisbury, North Carolina, United States, 28277

RECRUITING

United States, Pennsylvania

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States, 16635

RECRUITING

United States, Tennessee

M3 Wake Research

Chatanooga, Tennessee, United States, 27615

RECRUITING

United States, Texas

Accurate Clinical Research

Houston, Texas, United States, 77089

RECRUITING

United States, Texas

Accurate Clinical Research

Richmond, Texas, United States, 77089

RECRUITING

United States, Utah

Metrodora Institute

Salt Lake City, Utah, United States, 84119

RECRUITING

United States, Washington

Arthritis Northwest

Spokane, Washington, United States, 99204