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RSLV-132 for Sjögren's Syndrome
Phase 2
Recruiting
Research Sponsored by Resolve Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weight at least 45 kg
Positive anti-Ro/SSA antibody test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured daily from at least 7 days prior to first dose until 169 days after the first dose
Summary
This trial aims to see if a new medication, RSLV-132, can help improve the symptoms of Sjogren's syndrome in adults. The study will look at whether RSLV
Who is the study for?
This trial is for adult females diagnosed with Primary Sjögren's Syndrome (pSS) within the last 10 years, who experience symptoms like fatigue, dryness, and pain. Participants must test positive for anti-Ro/SSA antibodies and have significant symptom scores on specific scales. They should not be able to bear children or must use effective contraception if they can.
What is being tested?
The study tests whether RSLV-132 improves symptoms of pSS compared to a placebo. It involves taking the drug or placebo over 22 weeks with regular clinic visits and daily symptom recording. The study will also monitor blood levels of RSLV-132, immune response, and overall safety.
What are the potential side effects?
While the side effects are not detailed here, typically such trials assess common issues like injection site reactions, allergic responses to the medication, general discomforts such as headaches or nausea, and any changes in blood tests that might indicate other side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 45 kg.
Select...
I tested positive for anti-Ro/SSA antibodies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured daily from at least 7 days prior to first dose until 169 days after the first dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured daily from at least 7 days prior to first dose until 169 days after the first dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assessment of cardinal symptoms of Sjogren's
Secondary study objectives
Adverse events
RSLV-132 immunogenicity
RSLV-132 pharmacokinetics
+1 moreSide effects data
From 2019 Phase 2 trial • 28 Patients • NCT0324768630%
Fatigue
25%
Arthralgia
25%
Upper respiratory tract infection
20%
Viral upper respiratory tract infection
15%
Conjunctivitis
15%
Headache
10%
Dermatitis contact
10%
Dizziness
10%
Rash
10%
Rash papular
10%
Oropharyngeal pain
10%
Muscle spasms
10%
Weight increased
10%
Urinary tract infection
10%
Constipation
10%
Cough
5%
Hordeolum
5%
Pain in extremity
5%
Nausea
5%
Lower respiratory tract infection
5%
Infusion related reaction
5%
Joint injury
5%
Joint swelling
5%
Oedema peripheral
5%
Osteoarthritis
5%
Parotitis
5%
Palpitations
5%
Diarrhoea
5%
Mouth ulceration
5%
Viral infection
5%
Sleep disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
RSLV-132
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RSLV-132Experimental Treatment1 Intervention
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
Group II: PlaceboPlacebo Group1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
RSLV-132
2021
Completed Phase 2
~240
Find a Location
Who is running the clinical trial?
Resolve TherapeuticsLead Sponsor
4 Previous Clinical Trials
236 Total Patients Enrolled
James PosadaStudy DirectorResolve Therapeutics LLC
1 Previous Clinical Trials
112 Total Patients Enrolled