Tests nicotinamide for mild to moderate ulcerative colitis in adults

Trial details

Who runs it

University Hospital Schleswig-Holstein

Trial code

NCT06488625EU 2024-510807-13-00

Record updated

22 October 2026

Original description

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).Read full original descriptionShow less

A Phase II/III, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) for Induction and Maintenance Therapy in Patients With Mild to Moderately Active Ulcerative Colitis

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

Inclusion: General:; 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; Disease-specific:; 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; Histology supportive for the diagnosis of UC; Mild to moderate disease activity (at screening): modified Mayo score (mMS) 4-7 RB ≥ 1, endoscopic score ES ≥1 and SF ≥ 1; RHI > 4 (at screening endoscopy); Disease extent >15 cm from the anal verge (at screening endoscopy); Elevated level(s) of C-reactive protein (CRP) and/or faecal calprotectin during the screening period (levels above the reference range, measured by local laboratories); Full colonoscopy with no signs of malignancy either during screening or within one year before screening; Medication:; In the case of no oral 5-ASA therapy within the last 2 weeks before entry into screening with informed consent, any prior oral 5-ASA therapy is permitted and the patient is not allowed to receive 5-ASA during the study. In the case of oral 5-ASA therapy within 2 weeks before entry into screening with informed consent, the 5-ASA therapy should have been ongoing for > 3 months, should not be increased ≥ 4 weeks before screening endoscopy and should remain stable for ≥ 1 week before screening endoscopy at the maximum dose according to label or lower. This 5-ASA baseline medication must be kept stable in the induction period and may be reduced (but not increased again) in the maintenance period. In cases in which 5-ASA is dosed higher than the approved dose, the dose will be adjusted to the maximum approved dose at the time of randomization.

Exclusion: 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; Steroid-dependent or steroid-refractory UC; Previous colonic surgery, except for appendectomy; Alcohol or drug abuse within the last 2 years; Medications:; Rectal topical 5-ASA and/or rectal budesonide therapy (enemas, foams or suppositories) ≤ 2 weeks prior to screening endoscopy (up to 3 single doses allowed); Use of oral corticosteroids and/or oral budesonide ≤ 4 weeks prior to screening endoscopy; Previous use of immunosuppressants, Janus kinase inhibitors, sphingoside-1-phosphate receptor modulators or biologics; Use of antibiotics for the treatment of UC or probiotic medication within 6 weeks prior to screening endoscopy; Any need of parenteral therapies for the therapy of UC (except iron infusions); Participation in a clinical trial within 4 weeks prior to screening for this trial or intake of an investigational medicinal product (IMP) within the last 8 weeks or 5 half-lives (whichever is longer) prior to screening (or longer if necessary in the investigator's discretion); Severe UC disease activity (modified Mayo score >7); Stools positive for enteric pathogens; Clostridium difficile toxin (CDT)-positive infection; indications for other relevant infections including cytomegalovirus colitis, each at screening; Current or history of colon carcinoma, high grade colonic dysplasia or other malignancies except for completely resected basal cell carcinoma and squamous cell carcinoma of the skin; Moderate to severe renal impairment (glomerular filtration rate <60) at screening; Relevant bleeding or thrombotic disorders; Known hypersensitivity towards any component of the CICR-NAM or placebo tablets; Regulatory requirements; Any circumstances or medical conditions which could contradict a trial participation and lead the investigator to assess the patient as unsuitable for trial participation for any other reason; Moderate to severe anaemia (haemoglobin <9 g/dL) at screening; General health and UC:; Current or past diagnosis of complex fistulae, intra-abdominal or peritoneal abscesses, strictures with obstructive symptoms; Severe extraintestinal manifestations of UC requiring special treatment; Foreseeable need for hospitalisation; Patients under legal supervision or guardianship, including patients, who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities; Patients who are dependent on the investigator or the sponsor; Other:; Pregnant or breastfeeding women; Women of childbearing potential (WoCBP) not using highly effective contraception till at least 1 month after last dosing of IMP; Male participants with female partners of childbearing potential who are not willing to use a highly effective contraception till at least 1 month after last dosing of IMP; Indications that the patient may be unable to comply with the trial procedures, e.g. language barriers precluding adequate understanding or cooperation.

ClinicalTrials.gov NCT06488625 · EU CTIS 2024-510807-13-00