Omega Research Group | Omega Research Orlando, LLC
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About
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).
Full 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.
Enrollment
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Inclusion and exclusion criteria
KEY 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:
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
KEY EXCLUSION CRITERIA
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
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Central trial contact
Mary Garfield, MS; Azadeh Haghighi, MS
Data sourced from clinicaltrials.gov
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