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

Phase 2

Recruiting

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
RSLV-132	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	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

Primary Outcome Measures

Name	Time	Method
Assessment of cardinal symptoms of Sjogren's	Measured daily from at least 7 days prior to first dose until 169 days after the first dose	Change from baseline in Sjogren's symptoms on Day 169 assessed using the Sjogren's Symptom Activity Patient Reported Outcome (SSA-PRO) instrument

Secondary Outcome Measures

Name	Time	Method
Tiredness/fatigue assessment	Measured from before the first dose until Day 169	Change from baseline in the Patient Reported Outcomes Measurement Information System Fatigue Short Form 10a (PROMIS SF10a) on Day 169
Adverse events	From the first dose of Investigational Product until Day 211	Incidence of serious and non-serious adverse events
RSLV-132 immunogenicity	Measured from before the first dose until Day 211	Presence of antibodies to RSLV-132 measured using an immunoassay
RSLV-132 pharmacokinetics	Measured from before the first dose until Day 211	Serum concentrations of RSLV-132 using an assay measuring RNAse enzyme activity

Locations (14): Life Medical Research
🇺🇸
Miami Gardens, Florida, United States
Advanced Clinical Research Center
🇺🇸
San Diego, California, United States
Evolution Research Center
🇺🇸
Hialeah, Florida, United States
GNP Research
🇺🇸
Hollywood, Florida, United States
Joint and Muscle Research Institute
🇺🇸
Charlotte, North Carolina, United States
Onsite Clinical Solutions
🇺🇸
Salisbury, North Carolina, United States
Altoona Center for Clinical Research
🇺🇸
Duncansville, Pennsylvania, United States
M3 Wake Research
🇺🇸
Chatanooga, Tennessee, United States
Accurate Clinical Research
🇺🇸
Richmond, Texas, United States
Metrodora Institute
🇺🇸
Salt Lake City, Utah, United States
Arthritis Northwest
🇺🇸
Spokane, Washington, United States
Sarasota Arthritis Research Center
🇺🇸
Sarasota, Florida, United States
Tufts College
🇺🇸
Boston, Massachusetts, United States
Arthritis and Osteoporosis Consultants of the Carolinas
🇺🇸
Charlotte, North Carolina, United States