VE202 in Patients With Mild-to-Moderate Ulcerative Colitis (NCT05370885) | Clinical Trial Compass
TerminatedPhase 2
VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
Stopped: Following review of Part 1 study data, the Sponsor decided to terminate the study with immediate effect. Results indicated that VE202 was not superior to placebo on the primary or any of the secondary endpoints. No new safety concerns were observed.
United States114 participantsStarted 2023-05-08
Plain-language summary
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18 to 75 years of age
✓. Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization
✓. 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 with: (i.) Mayo endoscopic subscore of ≥ 2 based on screening flexible sigmoidoscopy; (ii.) Rectal bleeding score of ≥ 1
✓. Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulator for the treatment of UC
✓. If receiving corticosteroids, dose must be stable for at least 4 weeks before randomization
✓. 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
✕. A known diagnosis of primary sclerosing cholangitis
✕. Allergy to VE202 or any of its components
✕. Allergy to vancomycin or any of its components
✕. A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization
What they're measuring
1
Proportion of participants with endoscopic response on flexible sigmoidoscopy after 8 weeks of treatment with VE202 or placebo.
Timeframe: 8 Weeks
2
Percentage of participants with Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) that are treatment-related or Serious Adverse Events (SAEs) that are treatment-related in Part 1 and Part 2 of the study.
✕. 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)
✕. Receipt of Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation within 6 months prior to randomization
✕. Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)