Clinical trial NCT06440525: A Study of RSLV-132 in Females With Sjögren's Syndrome
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 Sjögren's Syndrome (pSS) With Moderate to Severe Symptom Burden
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Primary Sjögren Syndrome
Lead sponsor: Resolve Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-06-04
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Assessment of cardinal symptoms of Sjogren's
timeFrame: Measured daily from at least 7 days prior to first dose until 169 days after the first dose
Secondary outcomes:
measure: Tiredness/fatigue assessment
timeFrame: Measured from before the first dose until Day 169
measure: RSLV-132 pharmacokinetics
timeFrame: Measured from before the first dose until Day 211
measure: RSLV-132 immunogenicity
timeFrame: Measured from before the first dose until Day 211
measure: Adverse events
timeFrame: From the first dose of Investigational Product until Day 211
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Resolve Clinical Site
state: California
city: Boca Raton
country: United States
facility: Resolve Clinical Site
state: Florida
city: Boynton Beach
country: United States
facility: Resolve Clinical Site
state: Florida
city: Hialeah
country: United States
facility: Evolution Research Center
state: Florida
city: Hollywood
country: United States
facility: GNP Research
state: Florida
city: Miami Gardens
country: United States
facility: Life Medical Research
state: Florida
city: Miami
country: United States
facility: Resolve Clinical Site
state: Florida
city: Chicago
country: United States
facility: Resolve Clinical Site
state: Illinois
city: Boston
country: United States
facility: Tufts College
state: Massachusetts
city: Albuquerque
country: United States
facility: Resolve Clinical Site
state: New Mexico
city: Charlotte
country: United States
facility: Joint and Muscle Research Institute
state: North Carolina
city: Charlotte
country: United States
facility: Arthritis and Osteoporosis Consultants of the Carolinas
state: North Carolina
city: Salisbury
country: United States
facility: Onsite Clinical Solutions
state: North Carolina
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Katy
country: United States
facility: Resolve Clinical Site
state: Texas
city: McKinney
country: United States
facility: Resolve Clinical Site
state: Texas
city: Richmond
country: United States
facility: Accurate Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Resolve Clinical Site
state: Texas
city: Salt Lake City
country: United States
facility: Metrodora Institute
state: Utah
city: Spokane
country: United States
facility: Arthritis Northwest
state: Washington
Study officials:
affiliation: Resolve Therapeutics LLC
name: James Posada
role: STUDY_DIRECTOR
References:
citation: 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.