R-2487 in Patients With Sjogren's Syndrome (SS)

Study acronym: R-2487-SS-01
StatusNot Yet Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 30, 2028 → Aug 30, 2029
See other at-risk trials from Rise Therapeutics LLC

Record History

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  1. Primary completion pushed from Aug 30, 2028 to Aug 30, 2029 Show 4 more changesShow less
    • Start date: Jun 1, 2026 to Nov 1, 2026
    • Study completion pushed from Aug 30, 2028 to Nov 30, 2029
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Primary and study completion dates: Aug 30, 2027 to Aug 30, 2028
    • Start date: Jun 1, 2025 to Jun 1, 2026
    v4
  3. Primary and study completion dates: Aug 30, 2026 to Aug 30, 2027
    • Start date: Jun 1, 2024 to Jun 1, 2025
    v3
  4. Secondary endpoints revised (2)v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06297213
Lead Sponsor Rise Therapeutics LLC
Conditions
(from sponsor)		 Sjogren's Syndrome, Sjögren, Sjögren Syndrome, Unspecified
Related terms Sjogren's Syndrome
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov