R-2487 in Patients With Rheumatoid Arthritis

Part of paid clinical trials in San Diego, California.

Sponsor
Rise Therapeutics LLC
Study ID
NCT05961592
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • R-2487 DP — DRUG
    Probiotic

Study Details

The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Rheumatoid Arthritis. Patients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Rheumatoid Arthritis. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured.

Key Dates

First listed
Jul 27, 2023
Start date
Oct 19, 2023
Status verified
Jun 2026
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
73 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Four (4) week open label dose for Rheumatoid Arthritis patients
    R-2487 DP administered daily for 28 days
  • Experimental: Six (6) week open label dose for Rheumatoid Arthritis patients
    R-2487 DP administered daily for 42 days
  • Experimental: Four (4) week open label dose for Rheumatoid Arthritis with Secondary Sjorgrens Syndrome patients
    R-2487 DP administered daily for 28 days

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

Locations (6)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92037
Zachary Manalo, Study Coordinator
[email protected]
858-246-2387
Monica Guma, M.D. (PRINCIPAL_INVESTIGATOR)
St.Jude Clinical ResearchDoralFlorida33172
Shelia Linares, BSN
[email protected]
305-507-2273
Gustavo Torres, MD (PRINCIPAL_INVESTIGATOR)
AP Medical ResearchMiamiFlorida33165
Simon Gomez
[email protected]
305-400-8899
Idania Fernandez, MD (PRINCIPAL_INVESTIGATOR)
Edward Jenner ResearchPlantationFlorida33317
Lahari Cherukuri
[email protected]
954-676-7440
Steven Gelbard, MD (PRINCIPAL_INVESTIGATOR)
Altoona Center for ResearchDuncansvillePennsylvania16635
Tracey Madonna, MA
[email protected]
814-693-0300
Brenda Endress
[email protected]
8146930300
Alan Kivitz, MD (PRINCIPAL_INVESTIGATOR)
Prolato Clinical Research CenterHoustonTexas77054
Amy Hutson
[email protected]
832-338-9118
Michelle Eisenberg, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Diego, CA

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
University of California, San Diego· San Diego, CASt.Jude Clinical Research· Doral, FLAP Medical Research· Miami, FLEdward Jenner Research· Plantation, FLAltoona Center for Research· Duncansville, PAProlato Clinical Research Center· Houston, TX

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