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

Resolve Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Primary Sjögren Syndrome

Treatments: Drug: RSLV-132; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06440525

132-6

Details and patient eligibility

About

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

Enrollment: 106 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups, including a placebo group

RSLV-132

Experimental group

Description:

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

Treatment:

Drug: RSLV-132

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo