Study of Oral Controlled-Ileocolonic-Release Nicotinamide CICR-NAM for Treating Mild to Moderate Ulcerative Colitis in Adults A Randomized, Double-Blind, Placebo-Controlled Phase IIIII Trial Evaluating Two Dosage Levels

What this Trial Is About

Researchers are evaluating the efficacy and safety of oral controlled-ileocolonic-release nicotinamide CICR-NAM in adults with mild to moderately active ulcerative colitis UC. This phase IIIII double-blind, randomized, placebo-controlled trial aims to improve intestinal inflammation by increasing nicotinamide supply in the ileocolonic region, which may positively influence the intestinal microbiota composition. The study is sponsored by University Hospital Schleswig-Holstein. Participants will be randomly assigned to receive either 2 gday or 3 gday of CICR-NAM or a placebo, taken as six tablets daily to maintain blinding. The trial includes a 12-week induction period followed by a 40-week maintenance period, totaling 52 weeks of treatment. An optional open-label arm with 3 gday CICR-NAM is available for patients who complete induction but experience worsening symptoms. During the study, participants will self-administer tablets daily and attend regular visits for assessments. Researchers will monitor symptomatic remission over 12 weeks and clinical remission over 52 weeks. Evaluations include endoscopy, histology, and measurements of disease activity scores and biomarkers such as C-reactive protein and fecal calprotectin. Safety and adherence will also be closely observed throughout the trial period.

Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) in Patients With Mild to Moderately Active Ulcerative Colitis