EUCTR2021-001280-24-LT进行中（未招募）1 期
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients with Mild-to-Moderate Ulcerative Colitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Able and willing to provide written informed consent prior to initiation of any study specific procedure or drug administration and understands the potential risks and benefits of study enrollment and study drug administration. When appropriate, informed consent may be provided by a legally authorized representative (LAR).
- •2. 18 to 75 years of age.
- •3. Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization
- •4. Active mild to moderate UC, as defined by the following:
- •a. Disease that extends at least 15 cm from the anal verge
- •b. A modified Mayo score of 4 to 8 with:
- •i. Mayo endoscopic subscore of = 2 based on screening flexible sigmoidoscopy
- •ii. Rectal bleeding score of = 1
- •5. Is up to date with current local colorectal cancer surveillance recommendations (eg, has had a surveillance colonoscopy within 12 months if indicated based on extent and duration of UC); this may be performed during screening.
- •6. Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulators for the treatment of UC
- •7. If receiving corticosteroids, dose must be stable for at least 4 weeks and be no higher than 10 mg QD prednisone (or prednisone equivalent) or budesonide 9 mg QD.
- •8. Doses of other allowable UC medications (see Section 8.2.2 for details) must be stable for at least 8 weeks before randomization.
- •9. If a female patient (according to sex assignment at birth):
- •- Is not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to hysterectomy, bilateral oophorectomy, or bilateral tubal ligation
- •- If of childbearing potential, must have a negative pregnancy test and agree to either remain celibate or use a highly effective form of birth control (as defined in Appendix 1) from the time of enrollment until 3 months after the last dose of study drug
- •- Agrees not to donate eggs (ova, oocytes) for purposes of assisted reproduction from the time of enrollment until 3 months after the last dose of study drug
- •- Is not breastfeeding
- •10. If a male patient (according to sex assignment at birth):
- •- If not vasectomized, agrees to wear a condom when engaging in sexual intercourse with any partner of childbearing potential from the time of enrollment until 3 months after the last dose of study drug
- •- Agrees not to donate sperm for purpose of reproduction from the time of enrollment until 3 months after the last dose of study drug
- •11. Able and willing to follow study procedures (eg, comply with study visits and procedures, provide blood and stool samples).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Known history of CD or indeterminate colitis
- •2. A known diagnosis of primary sclerosing cholangitis
- •3. Allergy to VE202 or any of its components (Section 9.1.1)
- •4. Allergy to vancomycin or any of its components (Section 9.2)
- •5. A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization
- •6. Known or suspected toxic megacolon, abdominal abscess, and/or small bowel ileus at the time of screening
- •7. Any other anatomic or medical contraindication to flexible sigmoidoscopy
- •8. Evidence of an active infection
- •9. Recent fever, defined as > 38.0 °C (rectal equivalent) within 3 days prior to randomization
- •10. Receipt of FMT or other fecal-derived preparation within 6 months prior to randomization
- •11. Use of systemic or non-absorbable oral antibiotics within the prior 4 weeks before randomization or anticipated within the study period
- •12. Use of probiotics within the prior 2 weeks before randomization (consumption of food products such as yogurt, kombucha, kimchi, and kefir is permissible)
- •13. Receipt of herbal, botanical, or traditional medicinal preparations within the 2 weeks prior to randomization (consumption of mint, turmeric, or other herbal teas is permissible)
- •14. Active drug or alcohol abuse
- •15. Active colonic dysplasia
- •16. Presence of adenomatous polyp on screening endoscopy, or history of adenomatous polyps that were not removed
- •17. Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)
- •18. Active malignancy within the 2 years prior to randomization, with the exception of non-melanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has been treated with local excision for curative intent
- •19. For female patients (according to sex assignment at birth), expectation of pregnancy or lactation during the study period
- •20. Receipt of any investigational drug or vaccine within the 30 days prior to randomization
- •21. Receipt of any investigational biologic within 60 days or 5 half-lives prior to randomization, whichever is longer
- •22. Aspartate aminotransferase or alanine aminotransferase levels > 3×ULN
- •23. Total or direct bilirubin > 1.5×ULN or direct-to-total bilirubin ratio > 0.5
- •24. Evidence of decompensated cirrhosis
- •25. Serum albumin < 3.0 g/dL
- •26. Known active hepatitis B or hepatitis C, or any positive laboratory result consistent with active disease (eg, hepatitis B surface antigen, hepatitis C antibody [unless patient has a history of treatment with successful resolution and an undetectable viral load])
- •27. Known human immunodeficiency virus infection or other serious congenital or acquired immunodeficiency
- •28. Absolute neutrophil count < 1000/µL
- •29. Serum creatinine > 2×ULN or calculated creatine clearance < 30 mL/min
- •30. Inability or unwillingness to comply with protocol requirements
- •31. Any other active or poorly controlled comorbid condition that, in the opinion of the Investigator, may be expected to interfere with either study compliance or interpretation of study results
研究者
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