VE202 in Patients with Mild-to-Moderate Ulcerative Colitis
Purpose
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).
Conditions
- Ulcerative Colitis
- Colitis, Ulcerative
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 18 to 75 years of age 2. Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization 3. Active mild to moderate UC, as defined by the following: 1. Disease that extends at least 15 cm from the anal verge 2. 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 4. Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulator for the treatment of UC 5. If receiving corticosteroids, dose must be stable for at least 4 weeks before randomization 6. Doses of other allowable UC medications must be stable for at least 8 weeks before randomization
Exclusion Criteria
- Known history of Crohn's disease (CD) or indeterminate colitis 2. A known diagnosis of primary sclerosing cholangitis 3. Allergy to VE202 or any of its components 4. Allergy to vancomycin or any of its components 5. A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization 6. Use of probiotics or herbal, botanical, or traditional medicinal preparations within the 2 weeks prior to randomization (consumption of food products such as yogurt, kefir, kombucha, and herbal teas is permissible) 7. Receipt of Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation within 6 months prior to randomization 8. Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy) 9. Receipt of any investigational biologic within 60 days or 5 half-lives prior to randomization, whichever is longer
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment. |
In Part 1 of the study, patients in Group A will receive VE202 for 8 weeks. In Part 2 of the study, patients in Group A will receive VE202 placebo for 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment. |
|
|
Other Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment. |
In Part 1 of the study, patients in Group B will receive VE202 placebo for 8 weeks. In Part 2 of the study, patients in Group B will receive VE202 for 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment. |
|
Recruiting Locations
Boston Medical Center
Boston, Massachusetts 02118
Boston, Massachusetts 02118
More Details
- Status
- Recruiting
- Sponsor
- Vedanta Biosciences, Inc.
Detailed Description
A Phase 2 double-blind, placebo-controlled, randomized study to evaluate the safety, efficacy, and microbiota changes of VE202 in biologic-naïve patients with mild to moderate UC. In Parts 1 and 2 of the study, patients will receive VE202 or placebo for 8 weeks or 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.