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

NCT06440525 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 132-6
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 24

Brief 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

Outcome Measures

Primary Outcomes (1)

• Assessment of cardinal symptoms of Sjogren's

  Change from baseline in Sjogren's symptoms on Day 169 assessed using the Sjogren's Symptom Activity Patient Reported Outcome (SSA-PRO) instrument

  Measured daily from at least 7 days prior to first dose until 169 days after the first dose

Secondary Outcomes (4)

• Tiredness/fatigue assessment

  Measured from before the first dose until Day 169

• RSLV-132 pharmacokinetics

  Measured from before the first dose until Day 211

• RSLV-132 immunogenicity

  Measured from before the first dose until Day 211

• Adverse events

  From the first dose of Investigational Product until Day 211

Study Arms (2)

RSLV-132

EXPERIMENTAL

Intravenous infusions of 10 mg/kg RSLV-132 solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155) for a total of 22 weeks of treatment

Drug: RSLV-132

Placebo

PLACEBO COMPARATOR

Intravenous infusions of placebo solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155) for a total of 22 weeks of treatment

Drug: Placebo

Interventions

RSLV-132 DRUG

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

RSLV-132

Placebo DRUG

0.9% sodium chloride solution

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Resolve Therapeutics: lead

Study Sites (24)

Resolve Clinical Site

Chula Vista, California, 91910, United States

RECRUITING

Resolve Clinical Site

Tustin, California, 92780, United States

RECRUITING

Resolve Clinical Site

Boca Raton, Florida, 34994, United States

RECRUITING

Resolve Clinical Site

Boynton Beach, Florida, 33467, United States

RECRUITING

Evolution Research Center

Hialeah, Florida, 33024, United States

RECRUITING

GNP Research

Hollywood, Florida, 33024, United States

RECRUITING

Resolve Clinical Site

Miami, Florida, 33140, United States

RECRUITING

Life Medical Research

Miami Gardens, Florida, 33014, United States

RECRUITING

Resolve Clinical Site

Chicago, Illinois, 60607, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Tufts College

Boston, Massachusetts, 02111-1817, United States

RECRUITING

Resolve Clinical Site

Albuquerque, New Mexico, 87106, United States

RECRUITING

Joint and Muscle Research Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Arthritis and Osteoporosis Consultants of the Carolinas

Charlotte, North Carolina, 28208, United States

RECRUITING

Onsite Clinical Solutions

Salisbury, North Carolina, 28277, United States

RECRUITING

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

RECRUITING

Resolve Clinical Site

Nashville, Tennessee, 37203, United States

RECRUITING

Resolve Clinical Site

Austin, Texas, 78757, United States

RECRUITING

Resolve Clinical Site

Katy, Texas, 77449, United States

RECRUITING

Resolve Clinical Site

McKinney, Texas, 75069, United States

RECRUITING

Accurate Clinical Research

Richmond, Texas, 77089, United States

RECRUITING

Resolve Clinical Site

San Antonio, Texas, 78215, United States

RECRUITING

Metrodora Institute

Salt Lake City, Utah, 84119, United States

RECRUITING

Arthritis Northwest

Spokane, Washington, 99204, United States

RECRUITING

Related Publications (2)

• Posada J, Valadkhan S, Burge D, Davies K, Tarn J, Casement J, Jobling K, Gallagher P, Wilson D, Barone F, Fisher BA, Ng WF. Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjogren's Syndrome: A Randomized Clinical Trial. Arthritis Rheumatol. 2021 Jan;73(1):143-150. doi: 10.1002/art.41489. Epub 2020 Nov 22.

  PMID: 32798283 BACKGROUND

• Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts. Arthritis Rheumatol. 2017 Jan;69(1):35-45. doi: 10.1002/art.39859. Epub 2016 Oct 26.

  PMID: 27785888 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

RSLV-132

Study Officials

• James Posada

  Resolve Therapeutics LLC

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

(213) 459-2979; studies@patientwing.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 4, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)