NCT07665294尚未招募4 期
CURVE-UC: A Pragmatic Randomized, Double-blind, Placebo Controlled, Treat-through, Multi-site Pragmatic Interventional Study to Evaluate the Efficacy and Safety of Combination Curcumin-QingDai (CurQD) With Vedolizumab in Moderate to Severe Ulcerative Colitis (UC)
Ryan C Ungaro1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2026年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
研究概览
简要总结
The purpose of this research study is to test the efficacy and safety of the study intervention, CurQD or placebo (non-active pill), in combination with vedolizumab prescribed as standard of care for patients with ulcerative colitis (UC)..
详细描述
A prospective, 30-weeks long, treat-through, multi-center, parallel-group, double blind, placebo controlled, randomized pragmatic clinical trial to examine if there is added clinical benefit in participants with active UC receiving a combination VDZ+CurQD versus VDZ alone (with placebo). Moderately to severely active UC participants for whom VDZ was prescribed by their physician irrespective of the present trial as part of routine clinical care will be eligible. Moderate to severely active UC will be defined as a modified Mayo score of 5 to 9, with rectal bleeding score of ≥1, and with a sigmoidoscopy or colonoscopy sub-score of at least 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
participants are blinded
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years old (inclusive) at time of consent
- •Understand and sign the written voluntary informed consent form prior to any protocol specific procedures
- •History of established UC for >3 months as determined by standard clinical criteria
- •Active UC defined as a modified Mayo score of 5-9 with a rectal bleeding sub score [RBS] ≥1 and Mayo endoscopic score [MES] ≥2
- •Participant will have a minimum disease extent of at least 5 cm proximal from the anal verge
- •Subjects must be on stable doses of concomitant medications, defined as:
- •Participants on oral corticosteroids must be on a stable dose >2 weeks (dose not exceeding 20 mg/day prednisone, 9mg/day of budesonide, or equivalent) prior to screening
- •Participants on methotrexate (MTX), azathioprine (AZA), or 6-mercaptopurine (6-MP) must be on treatment at a stable dose >4 weeks prior to screening and until end of study
- •Participants on oral 5-aminosalicylates, mesalamine, or sulfasalazine must be on a stable dose for >4 weeks prior to screening and until end of study
- •Probiotics or anti-diarrheal at a stable dose ≥ 2 weeks prior to Screening and until the end of study
- •Participants who have been diagnosed with UC for ≥8 years must be up to date on their colorectal cancer screening per local guidelines by the time of randomization.
排除标准
- •Diagnosis of inflammatory bowel disease unclassified (IBD-U) or Crohn's colitis
- •Previously received VDZ or etrolizumab (another anti-integrin biologic therapy)
- •Receiving corticosteroids at a dose >20mg/day of prednisone within two weeks prior to enrollment
- •Participants who have been exposed to more than one advanced therapy medication (biologic or small molecule drug) before enrollment will be excluded
- •Receiving or planned concomitant biologic or small targeted small molecule advanced therapy (tumor necrosis factor antagonist, interleukin [IL]-12/23 antagonist, IL-23 antagonist, Janus kinase [JAK] inhibitor and/or sphingosine-1-phosphate [S1P] receptor modulator) with vedolizumab
- •Any calcineurin inhibitor use within 4 weeks prior to screening (e.g., cyclosporine, tacrolimus)
- •Participant with known hepatitis B or C infection
- •Participant with active or latent tuberculosis (that has not been adequately treated)
- •Participant has any active infection
- •Participant has fecal sample positive for enteric infection at screening
- •History of prior colectomy or ileal pouch anal anastomosis
- •Participants with fulminant UC, toxic megacolon, or hospitalized for UC currently or within prior 2 weeks
- •Severe lab abnormalities including hemoglobin < 8.0 g/dl, albumin < 3.0 g/dl, platelets < 100/mcl, AST > 2X upper limit of normal (ULN), ALT >2X ULN, total bilirubin >1.5X ULN
- •Participant with history of colon cancer or colonic dysplasia not adequately treated (i.e. polyp removed)
- •Any serious underlying disease other than UC that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study or would compromise participant safety (such as any unstable or uncontrolled medical disorder, class III or IV congestive heart failure, demyelinating disease)
- •History of primary sclerosing cholangitis
- •Renal impairment and reduced creatinine clearance defined as estimated glomerular filtration rate GFR (eGFR)<60mL/min
- •History of chronic liver disease (autoimmune hepatitis, cirrhosis, etc.)
- •Currently requiring total parental nutrition
- •History of solid organ transplantation
- •History of malignancy or lymphoproliferative disorder in the prior 5 years, other than
- •adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous
- •cell carcinoma, or nonmetastatic basal cell carcinoma of the skin.
- •History of venothromboembolism (DVT or PE) or known inherited or acquired hyper coagulation disorder
- •Currently taking anti-platelet agent (other than aspirin) or anti-coagulant (coumadin,
- •rivaroxaban, etc.)
- •History of human immunodeficiency virus (HIV) infection
- •Participant is pregnant or lactating or actively trying to become pregnant
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo comparator in same dosing frequency
干预措施: Placebo (Drug)
CurQD
Experimental
CurQD in 1-2 oral capsules twice a day, increasing doses up to 30 weeks.
Dose ranging from 470-1540mg curcumin and 300mg-600mg QingDai
干预措施: CurQD (Drug)
研究者
Ryan C Ungaro
Associate Professor
Icahn School of Medicine at Mount Sinai
研究点 (1)
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