A Phase 2 Study of RSLV-132 in Females With Primary Sjögren's Syndrome

Primary Sjögren Syndrome Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Impact of Intravenous RSLV-132 in Participants With Primary Sjögren's Syndrome (pSS) With Moderate to Severe Symptom Burden

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06440525
• Other study ID #: 132-06
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2024
• Est. completion date: July 2026

Study information

• Verified date: May 2024
• Source: Resolve Therapeutics
• Contact: James Posada
• Phone: (208) 727-7010
• Email: jp[@]resolvebio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: July 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

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

Related Conditions & MeSH terms

• Primary Sjögren Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• RSLV-132
Fc fusion protein comprised of catalytically active human ribonuclease (RNase) fused to human immunoglobulin G1 (IgG1)
• Placebo
0.9% sodium chloride solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Resolve Therapeutics

References & Publications (1)

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. — View Citation

Outcome

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