Double-blind, randomised, placebo-controlled phase II / III trial evaluating efficacy and safety of two different doses (2 g/d or 3 g/d) of oral controlled-ileocolonic-release nicotinamide (CICR-NAM) compared to placebo in patients with ulcerative colitis (UC).
The intended therapeutic use of CICR-NAM is to improve intestinal inflammation in adults with UC by topically increasing nicotinamide supply in the ileocolonic region and thus favourably influencing the composition of intestinal microbiota
Male and female patients with UC and 18 to 80 years of age (at the time of signing the informed consent).
Ability to understand and comply with the protocol.
Signed written informed consent.
Documented diagnosis of UC, with a minimum disease duration of 3 months prior to screening and ≥ 1 relapse, clinically defined using established criteria within the last 12 months.
Diagnosis of CD, microscopic colitis, ischaemic colitis, radiation colitis or indeterminate colitis.
Infectious colitis, diverticulitis or segmental colitis associated with diverticulosis (SCAD) within the last 6 months before screening.
Current or past diagnosis of complex fistulae, intra-abdominal or peritoneal abscesses, strictures with obstructive symptoms.
Severe UC disease activity (modified Mayo score >7).
University Hospital Schleswig-Holstein
Lead sponsor
Gesellschaft für Therapieforschung mbH
Collaborator
Funded by the German Federal Ministry of Research, Technology and Space (01KG2006)
Collaborator
Ced Service GmbH
Collaborator