Recruiting

Phase 2

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

Sponsor:

Resolve Therapeutics

Code:

NCT06440525

Conditions

Primary Sjögren Syndrome

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

RSLV-132

Placebo

Study Details

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

Study ID

NCT06440525

Start date

Dec 1, 2024

Status verified date

Jul, 2025

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 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

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

Study Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

RSLV-132

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

Placebo

0.9% sodium chloride solution

Primary outcome measure

Assessment of cardinal symptoms of Sjogren's [ Time Frame: Measured daily from at least 7 days prior to first dose until 169 days after the first dose ]

Central Contacts and Locations

Central contacts

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

(213) 459-2979 studies@patientwing.com

Locations

Resolve Clinical Site

Recruiting

Chula Vista, California, United States, 91910

Contacts

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

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information