RSLV-132 for Sjögren's Syndrome

Recruiting at 29 trial locations

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Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Resolve Therapeutics

Disqualifiers: Active autoimmune, Fibromyalgia, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 22 weeks

106 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, RSLV-132, to determine its effectiveness in reducing the symptoms of Sjögren's Syndrome, which causes extreme tiredness, dry eyes, and pain. Researchers aim to assess whether RSLV-132 can alleviate these symptoms and evaluate its safety compared to a placebo (a substance with no active drug). Participants will receive either the drug or a placebo over 22 weeks and will track their symptoms daily. This trial may suit individuals diagnosed with Sjögren's Syndrome, experiencing dry eyes and fatigue, and who have tested positive for anti-Ro antibodies. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have started new medications or changed your medications for Sjögren's symptoms in the last 4 weeks. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that RSLV-132 is likely to be safe for humans?

Research has shown that RSLV-132 is generally safe for people with Sjögren's Syndrome. Studies found that patients using RSLV-132 did not experience major side effects, and it is considered easy to tolerate.

Previous reports suggest that RSLV-132 might help with symptoms like fatigue, which many people with this condition experience. While more research is needed, these findings indicate that RSLV-132 could be a safe choice for those considering joining a trial. Always consult a healthcare provider to understand the benefits and risks before participating in any clinical study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Sjögren's?

RSLV-132 is unique because it targets Sjögren's Syndrome differently from current treatments like hydroxychloroquine or corticosteroids, which mainly address symptoms. RSLV-132 works by potentially modulating the immune system through intravenous administration of a new active ingredient, aiming to reduce the underlying inflammation more effectively. Researchers are excited because this approach could offer a more targeted way to manage the disease, possibly improving symptoms with fewer side effects compared to existing treatments.

What evidence suggests that RSLV-132 might be an effective treatment for Sjögren's Syndrome?

Research has shown that RSLV-132 might help reduce severe tiredness in people with primary Sjögren's Syndrome. In one study, patients reported feeling less tired after taking RSLV-132, based on four different measures of fatigue. Tiredness significantly impacts those with Sjögren's, affecting daily activities and work. While these results are encouraging, RSLV-132 remains under study in this trial to ensure its effectiveness and safety. Participants will receive either RSLV-132 or a placebo to further evaluate its benefits and risks. ^{1 2 3 4 5}

Who Is on the Research Team?

James Posada

Principal Investigator

Resolve Therapeutics LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am not able to have children or I am using effective birth control.

I weigh at least 45 kg.

I have signed a consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous infusions of RSLV-132 or placebo 13 times over 22 weeks

22 weeks

1 visit per week for the first 2 weeks, then every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) on Day 211

What Are the Treatments Tested in This Trial?

Interventions

• RSLV-132

Trial Overview 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.

How Is the Trial Designed?

Group I: RSLV-132 Experimental Treatment 1 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: Placebo Placebo Group 1 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

Who Is Running the Clinical Trial?

Resolve Therapeutics

Lead Sponsor

Trials

5

Recruited

340+

Published Research Related to This Trial

In a phase II clinical trial involving 30 patients with primary Sjögren's syndrome, RSLV-132 demonstrated significant improvements in fatigue-related measures, particularly the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the Digit Symbol Substitution Test (DSST).

The improvements in fatigue were correlated with increased expression of interferon-inducible genes, suggesting a potential mechanism of action for RSLV-132 in alleviating symptoms of primary Sjögren's syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjögren's Syndrome: A Randomized Clinical Trial. Posada, J., Valadkhan, S., Burge, D., et al.[2022]

In a study of 1237 patients with primary Sjögren syndrome (pSS), 67% reported adverse events after SARS-CoV-2 vaccination, primarily local and systemic symptoms, but no severe adverse events were noted, indicating a generally safe profile for the vaccine in this population.

The majority of vaccinated patients (approximately 95%) developed a positive humoral response with anti-SARS-CoV-2 antibodies, and only 0.24% experienced breakthrough infections, suggesting that the vaccine is effective in eliciting an immune response in patients with pSS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of SARS-CoV-2 vaccination in 1237 patients with primary Sjögren syndrome. Inanc, N., Kostov, B., Priori, R., et al.[2022]

In a phase III trial involving 187 adults with active primary Sjögren's syndrome, abatacept did not show significant clinical efficacy compared to placebo after 169 days, as measured by the primary endpoint of disease activity (ESSDAI).

Despite the lack of clinical benefit, abatacept demonstrated biological activity by affecting certain disease-relevant biomarkers and immune cell populations, with no new safety concerns identified during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of abatacept in active primary Sjögren's syndrome: results of a phase III, randomised, placebo-controlled trial. Baer, AN., Gottenberg, JE., St Clair, EW., et al.[2022]

In a follow-up study of 13 female patients with Sjögren's syndrome, belimumab treatment showed effectiveness in reducing disease activity, but symptoms worsened after the treatment was suspended, as indicated by an increase in ESSDAI scores from 3.5 to 7.0 over 12 months.

After stopping belimumab, there was a significant rise in rheumatoid factor levels and immunoglobulin levels, along with an increase in serum BLyS levels, suggesting that the drug effectively inhibited B cell proliferation during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of belimumab and targeting of rheumatoid factor-positive B-cell expansion in Sjögren's syndrome: follow-up after the end of the phase II open-label BELISS study. Quartuccio, L., Salvin, S., Corazza, L., et al.[2017]

Belimumab showed efficacy in improving symptoms of Primary Sjögren's syndrome (pSS), with 37% of patients reporting reduced dryness and 77% showing improvement in glandular manifestations at week 28, effects that persisted to week 52.

The treatment was well tolerated and safely administered among the 28 patients studied, although the overall evidence is limited due to the small number of studies available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of belimumab in Primary Sjögren's syndrome: A systematic review. Álvarez-Rivas, N., Sang-Park, H., Díaz Del Campo, P., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7839752/

A Randomized Clinical Trial - PMC - PubMed Central Administration of RSLV‐132 improved severe fatigue, as determined by 4 independent patient‐reported measures of fatigue, in patients with primary SS.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06440525

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

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724041785

OP0202 EFFECT OF RSLV-132 ON FATIGUE IN ... Fatigue is the key symptom that leads to poor health related quality of life and loss of work productivity in patients with primary Sjogren's syndrome (pSS).

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/595895

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

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03247686

A Study of RSLV-132 in Subjects With Primary Sjogren's ... This is a multi-center, double-blind, placebo-controlled study to evaluate the impact of 8 intravenous infusions of RSLV-132 in 28 patients with primary ...