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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis, Unspecified

In brief

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

Key facts

Study ID

NCT06488625

Run by

University Hospital Schleswig-Holstein

People needed

459

Starts

2024-09-12

Expected to finish

2027-12-01

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• General health and UC:
• 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).
• Severe extraintestinal manifestations of UC requiring special treatment.
• Steroid-dependent or steroid-refractory UC.
• Foreseeable need for hospitalisation.
• Previous colonic surgery, except for appendectomy.
• 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 anaemia (haemoglobin <9 g/dL) at screening.
• Moderate to severe renal impairment (glomerular filtration rate <60) at screening.
• Relevant bleeding or thrombotic disorders.
• 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).
• Known hypersensitivity towards any component of the CICR-NAM or placebo tablets.
• Regulatory requirements
• 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).
• 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.

Where it is running

• Universitaetsklinikum Ulm AöR — Ulm, Germany (enrolling)
• Universitaetsklinikum Schleswig-Holstein AöR — Lübeck, Germany (enrolling)
• Gastropraxis Magdeburg — Magdeburg, Germany (enrolling)
• Universitat Heidelberg — Mannheim, Germany (enrolling)
• Universitaetsklinikum Schleswig-Holstein AöR — Kiel, Schleswig-Holstein, Germany (enrolling)
• Universitaetsklinikum Augsburg — Augsburg, Germany (enrolling)
• Sozialstiftung Bamberg — Bamberg, Germany (enrolling)
• Charite Universitaetsmedizin Berlin KöR — Berlin, Germany (enrolling)
• Charite Universitaetsmedizin Berlin KöR — Berlin, Germany (enrolling)
• DRK Kliniken Berlin — Berlin, Germany (enrolling)
• Gesundheit Nord gGmbH Klinikverbund Bremen — Bremen, Germany (enrolling)
• Evangelisches Krankenhaus Kalk gGmbH — Cologne, Germany (enrolling)
• Gastroenterologie am Herrengarten — Darmstadt, Germany (enrolling)
• Gastroenterologische Schwerpunktpraxis Prof. Dr. Ludwig & Dr. med. Güthle — Dornstadt, Germany (enrolling)
• Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR — Dresden, Germany (enrolling)
• Goethe University Frankfurt — Frankfurt, Germany (enrolling)
• Agaplesion Frankfurter Diakonie Kliniken gGmbH — Frankfurt am Main, Germany (enrolling)
• Martin-Luther-Universitaet Halle-Wittenberg — Halle, Germany (enrolling)
• Gastropraxis an der St. Barbara-Klinik — Hamm, Germany (enrolling)
• Practice for Gastroenterology — Hanover, Germany (enrolling)
• Private Practice for Gastroenterology — Heidelberg, Germany (enrolling)
• St. Marien Und St. Annastiftskrankenhaus — Ludwigshafen, Germany (enrolling)
• Universitaetsklinikum Aachen AöR — Aachen, Germany
• Universitaet Muenster — Münster, Germany
• Medical Care Unit Dachau — Dachau, Germany

Full record on ClinicalTrials.gov

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