RecruitingPhase 1NCT05961592

R-2487 in Patients With Rheumatoid Arthritis

A Single and Repeat Dosing Study of the Safety, Drug Exposure and Clinical Activity of R-2487 in Patients With Rheumatoid Arthritis


Sponsor

Rise Therapeutics LLC

Enrollment

73 participants

Start Date

Oct 19, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called R-2487 in people with active rheumatoid arthritis (RA) — a condition where the immune system mistakenly attacks the joints — to evaluate its safety and potential effectiveness in reducing joint inflammation. **You may be eligible if...** - You are 18 to 75 years old with active RA (confirmed by standard classification criteria) and joint tenderness and swelling despite current treatment - You may continue hydroxychloroquine, methotrexate, or leflunomide during the study - Your steroid dose is stable and low (10 mg prednisone daily or less) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have another autoimmune disease (e.g., lupus, psoriasis, vasculitis, inflammatory bowel disease) - You have active, latent, or a history of tuberculosis (TB) - You have HIV, active hepatitis B or C - You have had a serious infection requiring hospitalization in the past 60 days - You have had a serious cancer in the past 5 years - You have advanced heart, kidney, or liver disease - You received certain biologic treatments (e.g., rituximab, adalimumab, tocilizumab) recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGR-2487 DP

Probiotic


Locations(5)

University of California, San Diego

San Diego, California, United States

St.Jude Clinical Research

Doral, Florida, United States

AP Medical Research

Miami, Florida, United States

Altoona Center for Research

Duncansville, Pennsylvania, United States

Prolato Clinical Research Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05961592


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