RSLV-132 for Sjögren's Syndrome

Recruiting at 25 trial locations

Overseen By James Posada

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?

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

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.

What safety data exists for RSLV-132 in humans?

In a clinical trial for Sjögren's Syndrome, RSLV-132 was tested for safety and effectiveness, indicating it has been evaluated in humans. ^{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 have signed a consent form.

I weigh at least 45 kg.

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 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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjögren's Syndrome: A Randomized Clinical Trial. [2022]

2. Italy 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. [2017]

3. Italy pubmed.ncbi.nlm.nih.gov

Safety and efficacy of SARS-CoV-2 vaccination in 1237 patients with primary Sjögren syndrome. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

Efficacy of belimumab in Primary Sjögren's syndrome: A systematic review. [2021]

5. England 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. [2022]