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Arthritis, RheumatoidPhase 1R-2487-RA01NCT05961592

R-2487 in Patients With Rheumatoid Arthritis

A Phase 1 study testing R-2487 DP in people with Arthritis, Rheumatoid, run by Rise Therapeutics LLC at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
R-2487 DP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
6 sitesUnited States
Study dates
19 Oct 2023to 31 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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,
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  • 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).
  • Prior history of or current inflammatory joint disease other than RA (such as psoriatic arthritis, gout, reactive arthritis, Lyme disease).
  • Subjects at risk for tuberculosis (TB) defined as follows: Current clinical, radiographic or laboratory evidence of active TB. Chest x-rays (posterior, anterior and lateral) obtained within the 3 months prior to obtaining written informed consent will be permitted but the images must be available and reviewed by the investigator. TB testing (IFN-gamma release assay or PPD) performed in the past month prior to Screening will be accepted; however, a copy of the report must be placed in the subject binder.
  • A history of active TB.
  • Subjects with a positive TB screening test indicative of latent TB including subjects currently being treated for latent tuberculosis infection (LTBI) will not be eligible for the study.
  • Subjects with recent acute infection defined as:
  • Any acute infection within 60 days prior to randomization that required hospitalization or treatment with parenteral antibiotics,
  • Any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy,
  • Subjects with history of chronic or recurrent bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis etc.),
  • Subjects with any history of infection of a joint prosthesis or artificial joint,
  • Subjects who have a history of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis),
  • Subjects with history of recurrent herpes zoster (more than 1 episode) or disseminated (more than 1 dermatome) herpes zoster or disseminated herpes simplex, or ophthalmic zoster will be excluded,
  • Symptoms of herpes zoster or herpes simplex must have resolved more than 60 days prior to screening,
  • Subjects with history of primary immunodeficiency.
  • Subjects with history of Human Immunodeficiency Virus (HIV) infection or who tested positive for HIV.
  • Evidence of infection with hepatitis B virus (HBV), hepatitis C virus (C), human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at screening.
  • Subjects who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non- metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Subjects who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.
  • Current clinical findings of a history of a demyelinating disorder.
  • New York Heart Association (NYHA) Class III or IV heart failure.
  • Subjects who have undergone a major surgical procedure within the 60 days prior to enrollment.
  • Subjects for whom 5 or more joints cannot be assessed for tenderness or swelling (i.e. due to surgery, fusion, amputation, etc.).
  • Current clinical findings of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, endocrine, neurological, or cerebral disease with laboratory values as following:
  • Hemoglobin level < 9.0 g/dL,
  • Absolute white blood cell (WBC) count of <3.0×109/L (<3000/mm3), or absolute neutrophil count of <1.2×109/L (<1200/mm3), or absolute lymphocyte count of <0.8×109/L (<800/mm3),
  • Thrombocytopenia, defined by platelet count <100×109/L (<100,000/mm3),
  • Chronic kidney disease defined as Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, based on the age-appropriate calculation,
  • Proteinuria ≥3+,
  • Total bilirubin (T-bili), aspartate aminotransferase (AST), alanine aminotransferase (ALT) more than 1.5 times upper limit of normal (ULN)
  • Previously diagnosed hepatic cirrhosis (Child Pugh A or higher) or previously diagnosed significant liver fibrosis (> F3).
  • Any form of vaccination in the last 30 days, to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Janet Stephens, PhD contact

6504178556

jstephens@risetherapeutics.com

Christian Freguia, PhD contact

2159231818

cfreguia@risetherapeutics.com

6 sites in 1 country

United States6 sites, 6 recruiting

  • St.Jude Clinical Research

    Doral, Florida, 33172

    Shelia Linares, BSN, 305-507-2273, slinares@stjudeclinicalresearch.com

    Gustavo Torres, MD

    Recruiting

  • Altoona Center for Research

    Duncansville, Pennsylvania, 16635

    Tracey Madonna, MA, 814-693-0300 ext. 147, traceymadonna@altoonaresearch.com

    Brenda Endress, 8146930300 ext. 202, brendaearnest@altoonaresearch.com

    Recruiting

  • Prolato Clinical Research Center

    Houston, Texas, 77054

    Amy Hutson, 832-338-9118, ahutson@prolato.org

    Michelle Eisenberg, M.D.

    Recruiting

  • AP Medical Research

    Miami, Florida, 33165

    Simon Gomez, 305-400-8899, simon@apmedresearch.com

    Idania Fernandez, MD

    Recruiting

  • Edward Jenner Research

    Plantation, Florida, 33317

    Lahari Cherukuri, 954-676-7440, l.cherukuri@edwardjmedicalresearch.com

    Steven Gelbard, MD

    Recruiting

  • University of California, San Diego

    San Diego, California, 92037

    Zachary Manalo, Study Coordinator, 858-246-2387, z2manalo@health.ucsd.edu

    Monica Guma, M.D.

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
R-2487 DP
Keywords
Arthritis, Rheumatoid
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R-2487 DPDrug

    Also called Drug

    Probiotic

Study groups in NCT05961592
Study groupRoleWhat they receive
Four (4) week open label dose for Rheumatoid Arthritis patientsExperimentalR-2487 DP administered daily for 28 days
Receives: Drug: R-2487 DP
Six (6) week open label dose for Rheumatoid Arthritis patientsExperimentalR-2487 DP administered daily for 42 days
Receives: Drug: R-2487 DP
Four (4) week open label dose for Rheumatoid Arthritis with Secondary Sjorgrens Syndrome patientsExperimentalR-2487 DP administered daily for 28 days
Receives: Drug: R-2487 DP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration

    To assess the number of participants with treatment-related adverse events after taking R-2487 (probiotic)

    Measured: Baseline through week 4

Secondary outcomes (2)

  1. Change in Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP)

    Change from Baseline in Disease Activity Score-28 joint C- Reactive Protein (DAS28-CRP) Score at Week 6 Describes severity of rheumatoid arthritis using clinical and laboratory data in swollen and tender joints. A score between 0 to 10 with the higher number indicating more active disease.

    Measured: Baseline through week 4

  2. Change in Simplified Disease Activity Index (SDAI) Score over time

    Baseline Simplified Disease Activity Index (SDAI) Score over time. The Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity [visual analogue scale (VAS) 0-10 cm] and level of C-reactive protein (mg/dl, normal <1 mg/dl).

    Measured: Baseline through week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start19 Oct 2023
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05961592
Sponsor's protocol ID
RISE-2487-RA01
Acronym
R-2487-RA01
Status last verified
Jun 2026
First submitted
18 Jul 2023
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing R-2487 DP in people with Arthritis, Rheumatoid, run by Rise Therapeutics LLC at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Janet Stephens, PhD (6504178556, jstephens@risetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration (time frame: Baseline through week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05961592.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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