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

Rise Therapeutics LLC

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.

Eligibility

Age range: 18–80 years
Sex: All
Healthy volunteers: No

Detailed 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 stud…

Interventions

Drug
R-2487
R-2487 DP

Locations (2)

The Johns Hopkins Jerome L. Greene Sjögren's Syndrome Center Johns Hopkins University - Rheumatology Department
Baltimore, Maryland
ppate132@jh.edu 410-550-9821
University of Michigan - Michigan Medicine
Ann Arbor, Michigan
aplucas@med.umich.edu 734-615-9865

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

Summary

Eligibility

Interventions

Locations (2)

Compensation

Run this study?

Details

Conditions