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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	Female

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06440525
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Resolve Therapeutics
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	James Posada
Principal Investigator Affiliation	Resolve Therapeutics LLC
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Primary Sjögren Syndrome

Arms & Interventions

Arms

Experimental: RSLV-132

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

Placebo Comparator: Placebo

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

Interventions

Drug: - RSLV-132

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

Drug: - Placebo

0.9% sodium chloride solution

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Resolve Clinical Site, Chula Vista, California

Status

Recruiting

Address

Resolve Clinical Site

Chula Vista, California, 91910

Site Contact

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