NCT05961592
Recruiting
Phase 1
A Single and Repeat Dosing Study of the Safety, Drug Exposure and Clinical Activity of R-2487 in Patients With Rheumatoid Arthritis
Overview
- Phase
- Phase 1
- Intervention
- R-2487 DP
- Conditions
- Arthritis, Rheumatoid
- Sponsor
- Rise Therapeutics LLC
- Enrollment
- 73
- Locations
- 5
- Primary Endpoint
- Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ages 18-75 years (Inclusive).
- •Able to provide written informed consent.
- •Men or women (not nursing or pregnant) who have active RA, defined as symptoms of RA prior to screening and have satisfied the ACR/EULAR 2010 criteria for the classification of RA prior to signing the informed consent.
- •Subjects must have a CDAI \> 10.0 at screening and have at least 3 tender and at least 3 swollen joints (excluding distal interphalangeal) at screening and at Day 1, based on the DAS28 joint count.
- •Subjects may be able to be on hydroxychloroquine, methotrexate, and leflunomide. Sulfasalazine use is not permitted.
- •Subjects may have received targeted synthetic DMARDs such as tofacitinib, baricitinib, and investigational therapies for RA if they have been washed out for 1 month prior to screening.
- •Subjects receiving oral corticosteroids must be on a stable dose and at the equivalent of ≤10 mg prednisone daily for at least 4 weeks. Subjects may not receive an IM, IV or IA administration of a corticosteroid within 4 weeks prior to screening visit or initiation of therapy.
- •All male and female subjects who are biologically capable of having children must agree to use a 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 study drug. Any pregnancy that occurs in the female partner of a male subject in the trial must be reported if it occurs at any time during the study.
- •Refrain from receiving any type of vaccinations during the study period (to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio).
Exclusion Criteria
- •Pregnancy (females, unless surgically sterile or at least two years post- menopausal must have a negative serum pregnancy test within 14 days prior to receiving the study drug and a negative urine pregnancy test on Study Day 0 before receiving the study drug).
- •Nursing mothers.
- •Subjects with autoimmune disease other than RA \[e.g., psoriasis, systemic lupus erythematosus (SLE), vasculitis, seronegative spondylarthritis, Inflammatory Bowel Disease, Sjogren's syndrome\] or currently active fibromyalgia.
- •Subjects should not receive any of the following medications:
- •Rituximab within 12 months prior to Day 1,
- •Abatacept within 3 months prior to Day 1,
- •Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or
- •Mycophenolate mofetil within 2 months prior to Day 1, or
- •Etanercept, Anakinra, Immunoglobulin, or blood products within 28 days prior to Day 1
- •Prior immunotherapy, including systemic corticosteroids, such prednisone, biologics, Janus kinase (JAK) inhibitors (such as tofacitinib, baricitinib or upadacitinib), ozanimod, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to Day 0, unless otherwise specified. In the case of cell-depleting therapies, such as B or T cell depletion, cell counts must have recovered to acceptable or baseline levels (use of licensed agents for indications not listed in the package insert is permitted).
Arms & Interventions
Four (4) week open label dose for Rheumatoid Arthritis patients
R-2487 DP administered daily for 28 days
Intervention: R-2487 DP
Six (6) week open label dose for Rheumatoid Arthritis patients
R-2487 DP administered daily for 42 days
Intervention: R-2487 DP
Four (4) week open label dose for Rheumatoid Arthritis with Secondary Sjorgrens Syndrome patients
R-2487 DP administered daily for 28 days
Intervention: R-2487 DP
Outcomes
Primary Outcomes
Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration
Time Frame: Baseline through week 4
To assess the number of participants with treatment-related adverse events after taking R-2487 (probiotic)
Secondary Outcomes
- Change in Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP)(Baseline through week 4)
- Change in Simplified Disease Activity Index (SDAI) Score over time(Baseline through week 4)
Study Sites (5)
Loading locations...
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Related News
Rise Therapeutics Advances Oral Immunotherapies R-2487 and R-3750 to Dose Expansion- Rise Therapeutics has completed the dose escalation stages for R-2487 and R-3750 clinical trials, advancing both oral immunotherapies to dose expansion.
- R-2487 is being evaluated for rheumatoid arthritis, aiming to modulate T regulatory cells and reduce inflammatory cytokines.
- R-3750 is under investigation for ulcerative colitis, seeking to reduce gut inflammation and improve intestinal barrier integrity.
- These trials aim to identify novel biomarkers and position the drugs for early intervention in disease progression.Rise Therapeutics Initiates Phase 1 Trial of R-2487 for Rheumatoid Arthritis- Rise Therapeutics has dosed the first patient in its Phase 1 clinical trial evaluating R-2487 for rheumatoid arthritis, marking a key milestone for the company.
- The Phase 1 trial (NCT05961592) aims to assess the safety, pharmacodynamics, and clinical activity of R-2487, a novel oral immunotherapeutic, in RA patients.
- Rheumatoid arthritis, a chronic inflammatory disorder, affects up to 1% of the US population, with women being disproportionately affected.
- R-2487 represents a commitment to deliver innovative new medicines to the clinical community.Rise Therapeutics Advances Oral Immunotherapies Across Multiple Phase 1 Trials- Rise Therapeutics is currently conducting a Phase 1 clinical trial for R-3750, an oral immune therapy, in patients with mild to moderate ulcerative colitis.
- A Phase 1 clinical trial is underway for R-2487, a targeted oral immune therapy designed to induce T regulatory cell populations, in patients with mild to moderate rheumatoid arthritis.
- Rise Therapeutics has initiated a double-blind, placebo-controlled clinical trial to assess the safety and efficacy of R-5280 in newly diagnosed type 1 diabetes patients.