NCT05961592招募中1 期
A Single and Repeat Dosing Study of the Safety, Drug Exposure and Clinical Activity of R-2487 in Patients With Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 73
- 试验地点
- 11
- 主要终点
- Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
- •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.
研究组 & 干预措施
Four (4) week open label dose for Rheumatoid Arthritis patients
Experimental
R-2487 DP administered daily for 28 days
干预措施: R-2487 DP (Drug)
Six (6) week open label dose for Rheumatoid Arthritis patients
Experimental
R-2487 DP administered daily for 42 days
干预措施: R-2487 DP (Drug)
Four (4) week open label dose for Rheumatoid Arthritis with Secondary Sjorgrens Syndrome patients
Experimental
R-2487 DP administered daily for 28 days
干预措施: R-2487 DP (Drug)
结局指标
主要结局
Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration
时间窗: Baseline through week 4
To assess the number of participants with treatment-related adverse events after taking R-2487 (probiotic)
次要结局
- 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)
研究者
研究点 (11)
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相关资讯
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.last yearRise 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.2 years agoRise 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.4 years ago