NCT05666960招募中1 期
A Single and Repeat Dosing Study of the Safety, Drug Exposure, and Clinical Activity of R-3750 in Patients With Mild to Moderate Ulcerative Colitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- To assess the tolerability of R-3750
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-3750) in patients with mild to moderate ulcerative colitis.
Patients will take an oral dosage of probiotic (R-3750) and provide patient-reported and physician scored measures of their colitis. Blood and fecal evaluations of inflammation and assessment of probiotic (R-3750) on fecal levels will also be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age
- •Ability to provide written informed consent
- •Confirmed diagnosed with UC by colonoscopy and histology and suffering from mild to moderate UC as defined by MMDAI with score of 3-9
- •On a stable dose of aminosalicylate (i.e. no change in medication within 4 weeks of study enrollment) and not planning to initiate new medication other than the study drug
- •For women of childbearing potential or men with a partner of childbearing potential, agree to use birth control methods (including hormonal contraceptives, intrauterine device (IUD) or hormone releasing system (IUS), vasectomy) and men will refrain from donating sperm during the study and at least 30 days after dosing (per FDA guidelines)
- •For the expansion cohort, a flexible sigmoidoscopy is required, unless an endoscopy was completed within 3 months from enrollment is available
- •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, planned pregnancy, breastfeeding women
- •Evidence of severe UC disease (MMDAI score greater than or equal to 10)
- •Evidence of any active or recent infection including chronic infectious disease such as Hepatitis B, C, or HIV
- •Evidence of any active or recent chronic chest infection with bronchiectasis or sinusitis, or covid-19 infection in the past 3 months
- •Treatment with immunosuppressants or anti-cancer drugs, e.g., anti-TNF-α agents, anti-integrin agents, azathioprine or 6-MP, 6-thioguanine, methotrexate, ozanimod, tofacitinid, upadacitinib, tacrolimus, cyclophosphamide, or cyclosporine or any other therapy that is not an aminosalicylate within the last 3 months
- •Received an investigational drug within 3 months (or 5 half-lives, whichever is longer) before study entry
- •Use of steroidal drugs to treat UC (e.g., prednisone >20 mg/day)
- •Use of probiotics within the last one (1) week and during the trial.
- •Treatment with systemic broad-spectrum antibiotics in the past 2 months
- •Major active systemic autoimmune disease other than UC
- •History of anaphylaxis or allergies to probiotics
- •History of alcohol or drug abuse within the past 2 years
- •History of stroke, or any cerebrovascular disease requiring medication/treatment
- •History of cancer, apart from successfully treated basal cell carcinoma or in situ carcinoma of the cervix >1 year prior to enrollment
- •Significant laboratory abnormalities, including liver transaminases (AST or ALT) > 1.5X the upper limit of normal.
- •Second degree or higher heart block or clinically significant arrythmia
- •Any other clinically significant renal, hepatic, hematological or other disease or laboratory abnormality which, in the opinion of the investigator, would interfere with the conduct, the interpretation of the safety signals or results of the trial, or would place the subject at unacceptable risk
- •Any condition or circumstance that, in the opinion of the Principal Investigator, would compromise the safety of the subject or the quality of study data
结局指标
主要结局
To assess the tolerability of R-3750
时间窗: 6 weeks
To assess the number of participants with treatment-realated adverse events after taking R-3750 (probiotic)
次要结局
- Clinical Response based on Inflammatory Bowel Disease Questionnaire (IBDQ) Scores(6 weeks)
研究者
研究点 (5)
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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 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