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Recruiting NCT06440525

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

Phase II Interventional Primary Sjögren Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RSLV-132, Placebo.
Who it may be relevant to
Registry conditions: Primary Sjögren Syndrome. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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 Disease With Moderate to Severe Symptom Burden

Overview

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

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • Tiredness/fatigue assessment [Time frame: Measured from before the first dose until Day 169]
  • RSLV-132 pharmacokinetics [Time frame: Measured from before the first dose until Day 211]
  • RSLV-132 immunogenicity [Time frame: Measured from before the first dose until Day 211]
  • Adverse events [Time frame: From the first dose of Investigational Product until Day 211]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 24 centers
  • Resolve Clinical Site — Chula Vista
  • Resolve Clinical Site — Tustin
  • Resolve Clinical Site — Boca Raton
  • Resolve Clinical Site — Boynton Beach
  • Evolution Research Center — Hialeah
  • GNP Research — Hollywood
  • Resolve Clinical Site — Miami
  • Life Medical Research — Miami Gardens
  • … and 16 more centers

Publications

  • Posada J, Valadkhan S, Burge D, Davies K, Tarn J, Casement J, Jobling K, Gallagher P, Wilson D, Barone F, Fisher BA, Ng WF. Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjogren's Syndrome: A Randomized Clinical Trial. Arthritis Rheumatol. 2021 Jan;73(1):143-150. doi: 10.1002/art.41489. Epub 2020 Nov 22. PMID 32798283
  • 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 Coho PMID 27785888

Identifiers

NCT: NCT06440525 · 132-6

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗