drugset / Trial / NCT03844932

A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis

NCT03844932

RandomizedParallel-groupTriple-blindTreatment

Summary

Study CYC-202 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ST-0529 in subjects with moderately to severely active UC, defined as a score of 5 to 9 on the 3-Component Adapted Mayo Score (comprised of rectal bleeding, stool frequency and endoscopy sub-scores; score range 0-9).

Timeline

Start
2019-01-24
Primary completion
2021-04-14
Completion
2021-04-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide 18.75 mg Oral
Subject Cyclosporine Peptide 37.5 mg Oral
Subject Cyclosporine Peptide 75 mg Oral

Indications