A randomised, double-blind, double-dummy, multicentre, phase III, non inferiority trial of an oral mesalazine formulation in patients with active mild to moderate ulcerative colitis for the induction of remission.

Ulcerative colitis

Percentage of patients with clinical remission defined by MMS ≤ 2 with symptomatic remission (stool frequency ≤ 1, rectal bleeding = 0) and endoscopic remission (MES ≤ 1) after 8 weeks of treatment.

[Secondary efficacy:] Percentage of patients achieving symptomatic remission (defined as stool frequency ≤ 1 and rectal bleeding = 0), after the 8-week treatment period, [Secondary efficacy:] Percentage of patients achieving endoscopic remission (defined as a MES ≤ 1), after the 8-week treatment period., [Secondary efficacy:] Percentage of patients achieving overall response (defined as a reduction in MMS ≥ 3 and ≥ 30% from baseline, with a decrease of rectal bleeding subscore ≥ 1 or absolute rectal bleeding subscore ≤ 1), after the 8 week treatment period., [Secondary efficacy:] Change in the symptomatic assessments of the MMS (stool frequency and rectal bleeding), from baseline to Week 8., [Secondary efficacy:] Change in the MES, from baseline to Week 8., [Secondary efficacy:] Percentage of patients achieving histological remission (defined by RHI ≤ 3 with subscores = 0 for lamina propria neutrophils and neutrophils in epithelium) at Week 8., [Secondary efficacy:] Percentage of patients achieving overall remission (all modified Mayo subscores = 0) at Week 8., [Secondary efficacy:] Percentage of patients achieving clinical remission and histologic remission at Week 8., [Secondary efficacy:] Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ), from baseline to Week 8., [Secondary efficacy:] Change in faecal calprotectin values, from baseline (V2) to Week 8., [Secondary safety and tolerability:] Monitoring adverse events: - Incidence of adverse events (related/unrelated). - Incidence of adverse events by maximum severity (related/unrelated). - Incidence of serious adverse events (related/unrelated). - Incidence of adverse events leading to discontinuation of trial drug. - Incidence of adverse events resulting in death., [Secondary safety and tolerability:] Biochemistry, haematology, and urinalysis: - Number of patients with clinically significant results at Week 8 in haematological parameters. - Number of patients with clinically significant results at Week 8 in biochemical parameters. - Number of patients with clinically significant results at Week 8 in urinalysis parameters., [Secondary safety and tolerability:] Physical examination and vital signs - Number of patients with clinically significant findings in physical examination from baseline (V2) to Week 8. - Changes in vital signs parameters from baseline (V2) to Week 8., [Secondary safety and tolerability:] Preference of the pharmaceutical formulation of the IMP evaluated through the Treatment Satisfaction and Acceptability Questionnaire.

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