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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured daily from at least 7 days prior to first dose until 169 days after the first dose for reporting.

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 more

Side effects data

From 2019 Phase 2 trial • 28 Patients • NCT03247686

30%

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%

Oropharyngeal pain

10%

Rash papular

10%

Weight increased

10%

Muscle spasms

10%

Urinary tract infection

10%

Constipation

10%

Cough

Lower respiratory tract infection

Joint injury

Pain in extremity

Nausea

Joint swelling

Osteoarthritis

Infusion related reaction

Oedema peripheral

Hordeolum

Parotitis

Palpitations

Diarrhoea

Mouth ulceration

Viral infection

Sleep disorder

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met