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

Description

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

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Study Overview

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Study Details

Study overview

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

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 Syndrome (pSS) with Moderate to Severe Symptom Burden

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

Condition
Primary Sjögren Syndrome
Intervention / Treatment

-

Contacts and Locations

San Diego

Advanced Clinical Research Center, San Diego, California, United States, 92108

Hialeah

Evolution Research Center, Hialeah, Florida, United States, 33024

Hollywood

GNP Research, Hollywood, Florida, United States, 33024

Miami Gardens

Life Medical Research, Miami Gardens, Florida, United States, 33014

Sarasota

Sarasota Arthritis Research Center, Sarasota, Florida, United States, 34239

Boston

Tufts College, Boston, Massachusetts, United States, 02111-1817

Charlotte

Joint and Muscle Research Institute, Charlotte, North Carolina, United States, 28204

Charlotte

Arthritis and Osteoporosis Consultants of the Carolinas, Charlotte, North Carolina, United States, 28208

Salisbury

Onsite Clinical Solutions, Salisbury, North Carolina, United States, 28277

Duncansville

Altoona Center for Clinical Research, Duncansville, Pennsylvania, United States, 16635

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Resolve Therapeutics,

James Posada, STUDY_DIRECTOR, Resolve Therapeutics LLC

Study Record Dates

2026-07-01