Study of VE202 in Patients with Ulcerative Colitis
- Conditions
- Mild-to-moderate ulcerative colitis (UC)MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2021-001280-24-HU
- Lead Sponsor
- Vedanta Biosciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
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. Male or female patient who is 18 to 75 years of age.
3. Documented clinical and endoscopic diagnosis of UC at least 3 months prior to enrollment.
4. Active mild to moderate UC, as defined by the following:
? Disease that extends at least 15 cm from the anal verge
? A modified Mayo score of 4 to 8
? Mayo endoscopic subscore as follows, based on screening flexible sigmoidoscopy:
i. Subscore of 1, combined with a fecal calprotectin level of = 150 µg/g, or
ii. Subscore of 2
? 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 not received a biologic agent or Janus kinase inhibitor for the treatment of UC or any other medical condition.
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.
9. If a female patient:
? 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:
? 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
1. Known history of CD or indeterminate colitis
2. A known diagnosis of primary sclerosing cholangitis
3. Allergy to vancomycin
4. A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to enrollment
5. Known or suspected toxic megacolon, abdominal abscess, and/or small bowel ileus at the time of enrollment
6. Any other anatomic or medical contraindication to flexible sigmoidoscopy
7. Evidence of an active infection
8. Recent fever, defined as > 38.0 °C (rectal equivalent) within 3 days prior to randomization
9. Receipt of FMT or other fecal-derived preparation within 6 months prior to enrollment
10. Use of systemic or non-absorbable oral antibiotics within the prior 4 weeks or anticipated within the study period
11. Use of probiotics within the prior 2 weeks (consumption of yogurt and kefir are permissible)
12. Receipt of herbal, botanical, or traditional medicinal preparations within the prior 2 weeks (consumption of mint, turmeric, or other herbal teas is permissible)
13. Active drug or alcohol abuse
14. Active colonic dysplasia
15. Presence of adenomatous polyp on screening endoscopy, or history of adenomatous polyps that were not removed
16. Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)
17. Active malignancy within the past 2 years, 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
18. For female patients, expectation of pregnancy or lactation during the study period
19. Receipt of any investigational drug or vaccine within the 30 days prior to enrollment
20. Receipt of any investigational biologic within 60 days or 5 half-lives prior to enrollment, whichever is longer
21. Aspartate aminotransferase or alanine aminotransferase levels > 3 × ULN
22. Total or direct bilirubin > 1.5 × ULN
23. Evidence of decompensated cirrhosis
24. Serum albumin < 3.0 g/dL
25. 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])
26. Known human immunodeficiency virus infection or other serious congenital or acquired immunodeficiency
27. Absolute neutrophil count < 1000/µL
28. Serum creatinine > 2 × ULN or calculated creatine clearance < 30 mL/min
29. Inability or unwillingness to comply with protocol requirements
30. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method