NL-OMON51131招募中4 期
VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT
Alimentiv B.V.0 个研究点目标入组 38 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects must meet each of the following criteria for enrollment into the study:
- •1. Age >= 18 years
- •2. Diagnosis of UC confirmed by clinical, endoscopic, and histological evidence
- •prior to screening as per standard criteria
- •3. Moderately to severely active UC with a Mayo rectal bleeding subscore >= 1
- •and a MES >= 2, with minimum disease extent of 15 cm and objective evidence of
- •inflammation that can be visualized using central endoscopic imaging system
- •4. Ability of subject to participate fully in all aspects of this clinical trial
- •5. Written informed consent must be obtained and documented
- •6. Agree not to participate in an investigational trial for the duration of the
- •trial (observation or other noninterventional trials may be permitted at the
- •discretion of the investigator)
- •7. Negative standard of care tuberculosis (TB) test and hepatitis B and C test
- •prior to randomization, unless negative results available from within 12 months
- •8. A male subject who is nonsterilized and sexually active with a female
- •partner of childbearing potential agrees to use adequate contraception* from
- •signing of informed consent throughout the duration of the study and for 18
- •weeks after last dose
- •9. A female subject of childbearing potential* who is sexually active with a
- •nonsterilized male partner agrees to use routinely adequate contraception from
- •signing of informed consent throughout the duration of the study and for 18
- •weeks after last dose
- •10. Up to date with colorectal carcinoma surveillance according to local
- •standards and guidelines. If a subject is not up to date at screening, a
- •standard of care surveillance assessment may be performed during the screening
- •11. Subjects who are not responding to their existing treatment for UC
- •(Netherlands-specific criterion).
排除标准
- •Subjects who exhibit any of the following conditions are ineligible for the
- •1. Subjects who have historically failed (i.e., had an inadequate response
- •with, lost response to, or were intolerant to) 2 or more compounds or classes
- •of advanced therapeutic options (biologics or small molecules; e.g., anti-TNFs,
- •ustekinumab, or tofacitinib) for the treatment of their UC
- •2. Current or previous treatment with vedolizumab, etrolizumab, or natalizumab
- •3. Topical therapy (corticosteroid or 5-aminosalicylate [5-ASA]) use within 2
- •weeks prior to screening endoscopy
- •4. Change to oral corticosteroid dosing within 2 weeks prior to randomization
- •or a corticosteroid dose of > 30 mg of prednisone or equivalent at
- •randomization
- •5. Known diagnosis of CD, indeterminate colitis, ischemic colitis, radiation
- •colitis, diverticular disease associated with colitis, or microscopic colitis
- •6. Short gut syndrome
- •7. Positive stool culture for or active Clostridiodes difficile infection
- •8. Pregnant women
- •9. Known hepatitis B or C infection. If a negative test result is available in
- •the 12 months prior to randomization, retesting is not required
- •10. Known active or latent TB. If a negative test results is available in the
- •12 months prior to randomization, confirmatory testing (per standard of care)
- •is not required before randomization.
- •11. Received any investigational drug within 30 days prior to enrollment/target
- •12. Serious underlying disease other than UC that in the opinion of the
- •investigator may interfere with the subject*s ability to participate fully in
- •the study or would compromise subject safety (such as history of malignancies,
- •major neurological disorders, or any unstable or uncontrolled medical disorder)
- •13. History of alcohol or drug abuse that in the opinion of the investigator
- •may interfere with the subject*s ability to comply with the study procedures
- •14. The subject has active cerebral/meningeal disease, signs, symptoms, or any
- •history of progressive multifocal leukoencephalopathy (PML) prior to
- •randomization
- •15. Hypersensitivity to any excipient of vedolizumab
- •16. History of HIV or positive test at screening (Italy-specific criterion).
- •17. Any other contraindication(s)to vedolizumab (Italy-specific criterion).
- •18. If female, the subject is pregnant or lactating or intending to become
- •pregnant before, during, or within 18 weeks after the last dose; or intending
- •to donate ova during such time period.
- •19. If male, the subject intends to donate sperm during the course of this
- •study or for 18 weeks after the last dose.
- •20. Vaccination with a live or live-attenuated vaccine within 4 weeks prior to
- •randomization, or planned vaccination during conduct of the study, except
- •vaccination for coronavirus disease of 2019 (COVID-19)
研究者
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