NL-OMON49621撤回4 期
VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target - VERDICT
Robarts Clinical Trials0 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
- 撤回
- 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 histopathological
- •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 trials without investigational product may be permitted at
- •the discretion of the investigator)
- •7. Negative standard of care tuberculosis (TB) test and hepatitis B and C test
- •randomization, unless negative results available from within 12 months prior
- •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
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 known C. 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. Active severe infection such as sepsis, cytomegalovirus, listeriosis, or
- •opportunistic infection.
研究者
相似试验
招募中
4 期
VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment targetUlcerative colitisNL-OMON51131Alimentiv B.V.38
招募中
4 期
VERDICT - Optimal Treatment Target in Active Ulcerative Colitis (UC)Ulcerative colitis2024-514183-21-00Alimentiv Inc.391
进行中（未招募）
1 期
Determination of the Optimal Treatment Target in Ulcerative ColitisEUCTR2019-002485-12-GBAlimentiv Inc. (formerly Robarts Clinical Trials)660
进行中（未招募）
1 期
Determination of the Optimal Treatment Target in Ulcerative ColitisEUCTR2019-002485-12-NLAlimentiv Inc.660
进行中（未招募）
1 期
Determination of the Optimal Treatment Target in Ulcerative ColitisEUCTR2019-002485-12-PLAlimentiv660