A Single and Repeat Dosing Study of the Safety, Drug Exposure and Clinical Activity of R-2487 in Patients With Sjogren's Syndrome (SS)

Rise Therapeutics LLC0 sites36 target enrollmentJune 1, 2026

ConditionsSjogren's Syndrome Sjögren Sjögren Syndrome, Unspecified

InterventionsR-2487

DrugsR-2487

Overview

Phase: Phase 1
Intervention: R-2487
Conditions: Sjogren's Syndrome
Sponsor: Rise Therapeutics LLC
Enrollment: 36
Primary Endpoint: Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration
Status: Not yet recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Sjogren's Syndrome.

Patients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Sjogren's Syndrome. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured.

Registry

clinicaltrials.gov

Start Date

June 1, 2026

End Date

August 30, 2028

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Rise Therapeutics LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of SS according to American-European Consensus Group Criteria
•Able to provide informed consent
•Subjects receiving prednisone (10 mg or less/day) must be on a stable dose for more than 2 weeks
•All male and female subjects who are biologically capable of having children must agree to use medically acceptable method of birth control for the duration of the study. All female subjects who are biologically capable of having children must have a negative pregnancy test result before administration of investigational product.
•The use of probiotics prior to study enrollment is accepted; however, during the course of the study, the use of probiotics is forbidden.

Exclusion Criteria

•No known active overlapping or associated other autoimmune disease
•Prior allogenic or autologous bone marrow or organ transplantation
•Subjects with prior irradiation to the head and neck, including radioactive iodine treatment for hyperthyroidism
•Subjects who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Subjects who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.
•Subjects with positive results for human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
•Subjects with active viral, bacterial, or fungal infection, or history of severe opportunistic infection within the preceding 3 months, or COVID-19 infection in the past 3 months
•Subjects with evidence of active or latent tuberculosis
•Active infection of the salivary or lacrimal glands
•Prior immunotherapy, biologics, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to the first dose of R-2487 DP
•Pregnant or breastfeeding women

Arms & Interventions

Open Label

Probiotic

Intervention: R-2487

Outcomes

Primary Outcomes

Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration

Time Frame: Baseline through Week 4

To assess the number of participants with treatment-related adverse events after taking R-2487 (probiotic)

Secondary Outcomes

Change in Patient reported general health questionnaire Short Form Health Survey-36(SF-36)(Baseline through week 4)
Change in disease activity through Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ClinESSDAI)(Baseline through Week 4)