COLLECTIVE202 is a double-blind, placebo-controlled, Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).
- VE202 is administered as oral capsules containing 16 strains of bacteria that are often found in the normal human intestine.
- 100 participants (18 to 75 years of age) with an endoscopically confirmed diagnosis of UC at least 3 months prior to enrollment will be evaluated for further eligibility and upon confirmation, will be randomly assigned to one of two groups.
- The study will be conducted in 3 parts, lasting 56 weeks. Participants are expected to complete all 3 parts of the study.
- Subjects in Group A will receive VE202 in Part 1 of the study and a matching placebo in Part 2 of the study. Subjects in Group B will receive placebo in Part 1 of the study and VE202 in Part 2 of the study.
- Part 3 of the study will follow study participants to evaluate the clinical course of their UC disease and to assess the safety profile of previously-administered VE202.
For more information about the study including contact details, please visit Clinicaltrials.gov at https://clinicaltrials.gov/ct2/show/NCT05370885.
In two Phase 1 studies in healthy volunteers, VE202 was generally safe and well tolerated at all doses and demonstrated durable and dose-dependent colonization. Vedanta expects to begin a Phase 2 study in IBD patients in 2023.
For additional study information, please visit Clinicaltrials.gov: