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

ConditionPrimary Sjögren Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorResolve Therapeutics

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • RSLV-132

    Drug

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

  • Placebo

    Drug

    0.9% sodium chloride solution

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: RSLV-132Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Measured daily from at least 7 days prior to first dose until 169 days after the first dose

Secondary outcomes

1

Tiredness/fatigue assessment

Change from baseline in the Patient Reported Outcomes Measurement Information System Fatigue Short Form 10a (PROMIS SF10a) on Day 169

Time frame
Measured from before the first dose until Day 169
2

RSLV-132 pharmacokinetics

Serum concentrations of RSLV-132 using an assay measuring RNAse enzyme activity

Time frame
Measured from before the first dose until Day 211
3

RSLV-132 immunogenicity

Presence of antibodies to RSLV-132 measured using an immunoassay

Time frame
Measured from before the first dose until Day 211
4

Adverse events

Incidence of serious and non-serious adverse events

Time frame
From the first dose of Investigational Product until Day 211

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Resolve Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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