R-2487 in Patients With Sjogren's Syndrome (SS)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRise Therapeutics LLC
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- R-2487
Treatment groups
36 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov