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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
R-2487
DrugR-2487 DP
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Open LabelOther 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration
To assess the number of participants with treatment-related adverse events after taking R-2487 (probiotic)
Time frame
Baseline through Week 4Secondary outcomes
1
Change in disease activity through Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ClinESSDAI)
Change from Baseline in Disease Activity Score at Week 4 to assess the disease severity of Sjogren's syndrome using data without laboratory results
Time frame
Baseline through Week 42
Change in Patient reported general health questionnaire Short Form Health Survey-36(SF-36)
Baseline Short Form Health Survey-36 (SF-36) Score over time. The Baseline Short Form Health Survey is the numerical sum of 36 patient reported outcome parameters of quality of life. The higher the score the more favorable the reflection of the quality of life.
Time frame
Baseline through week 4Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: