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

Sponsor
Rise Therapeutics LLC
Study ID
NCT06297213
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Sjogren's Syndrome
  • Sjögren
  • Sjögren Syndrome, Unspecified

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • R-2487 — DRUG
    R-2487 DP

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Aug 2025
Primary completion
Aug 30, 2028
Completion
Aug 30, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Open Label
    Probiotic

Primary Outcome Measure

Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration [ Time Frame: Baseline through Week 4 ]

Central Contacts

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