The purpose of this study is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active ulcerative colitis. Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period.
This is a Phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active UC. Randomization will be stratified by Mayo score. Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period. The total duration of the study will be 20 weeks, excluding the screening period. The primary objective is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active UC. The secondary objectives are to evaluate the effect of PRV-300 for 12 weeks in subjects with active UC on: * Pharmacodynamics: Changes in gene scores in colonic biopsies over the course of treatment. * Pharmacokinetics: Peak (Cmax) and trough (Cmin) serum concentrations of PRV-300 in subjects with active UC. * Immunogenicity: Immunogenicity of PRV-300 in subjects with active UC * Endoscopic: Trends in endoscopic disease activity in subjects with active UC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
37
Clinical Site
Tbilisi, Georgia
Clinical Site
Chisinau, Moldova
Clinical Site
Kapitanivka, Ukraine
Incidence of Treatment-emergent adverse events (TEAEs),
Assessment of safety and tolerability
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.