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Study of controlled-release nicotinamide (CICR-NAM) tablets for treating mild to moderate ulcerative colitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. The research examines a new medication called CICR-NAM, which contains nicotinamide (a form of vitamin B3) in a special tablet form that releases the medicine in specific parts of the intestines.

The purpose of this research is to determine how well CICR-NAM works and how safe it is for treating mild to moderate ulcerative colitis. The study will compare CICR-NAM to a placebo over a period of 52 weeks. During the study, some participants will receive CICR-NAM tablets while others will receive placebo tablets.

The medication will be given as film-coated tablets that participants take by mouth. The treatment period is divided into two parts: the first 12 weeks will focus on initial improvement of symptoms, and the following 40 weeks will evaluate long-term benefits. The maximum daily dose of the medication will be 3 grams.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive either CICR-NAM tablets or placebo tablets (tablets without active medication) to take by mouth

    This first phase of treatment lasts for 12 weeks

    If you are currently taking 5-ASA medication (a common medication for ulcerative colitis), you will continue it at the same dose during this phase

  2. Step 2

    First evaluation period

    After 12 weeks, your condition will be evaluated through medical examination

    The doctors will check your symptoms and perform tests to look at your intestines

    They will assess if your condition has improved by examining your symptoms and conducting a visual examination of your intestinal lining

  3. Step 3

    Extended treatment phase

    If you continue in the study, the treatment will extend until week 52 (one year total)

    You will continue taking either CICR-NAM or placebo tablets

    If you are on 5-ASA medication, the dose may be reduced during this phase, but cannot be increased

  4. Step 4

    Final evaluation

    At week 52, your condition will be evaluated again

    The doctors will check if you have achieved clinical remission (significant improvement in your condition)

    They will perform examinations similar to those done at week 12 to assess your intestinal health

Who can join the trial?

8 criteria

  • Must be between 18 and 80 years old
  • Must have been diagnosed with ulcerative colitis for at least 3 months before screening
  • Must have experienced at least one disease flare-up in the past 12 months
  • Must have mild to moderate disease activity with: - Signs of rectal bleeding - Visible changes in the intestinal lining during endoscopy (examination of the bowel with a camera) - Increased stool frequency
  • Must have inflammation score greater than 4 on the Robarts Histology Index (a measure of disease activity seen under microscope)
  • Must have disease affecting an area larger than 15 centimeters from the anal opening
  • Regarding medication called 5-ASA (an anti-inflammatory drug): - If not taking 5-ASA in the past 2 weeks: can participate but cannot start during study - If currently taking 5-ASA: must have been taking it for more than 3 months, with stable dose for at least 4 weeks - Daily dose must not exceed 3 grams (brief exceptions up to 3 days allowed)
  • Both men and women can participate

Who cannot join the trial?

15 criteria

  • Age under 18 or over 65 years
  • Severe form of ulcerative colitis (a condition affecting the colon)
  • Pregnancy or breastfeeding
  • Current participation in other clinical trials
  • History of allergic reactions to similar medications
  • Major surgery in the past 3 months
  • Active or chronic infections
  • Serious heart, liver, or kidney problems
  • Cancer diagnosis within the last 5 years
  • Use of prohibited medications that could interfere with the study drug
  • Inability to follow study procedures or attend scheduled visits
  • History of substance abuse in the past 12 months
  • Mental health conditions that could affect study participation
  • Inflammatory bowel conditions other than ulcerative colitis
  • Abnormal laboratory test results that could indicate other health issues
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Investigated drugs

CICR-NAM (Controlled-Ileocolonic-Release Nicotinamide) is an oral medication being studied for treating ulcerative colitis. It is a special form of nicotinamide (a form of vitamin B3) that is designed to be released specifically in the intestines. This controlled release system helps the medication reach the areas of the intestine affected by ulcerative colitis. The medication aims to reduce inflammation and improve symptoms in patients with mild to moderate ulcerative colitis. A placebo is also used in this trial as a control substance. It looks identical to the active medication but contains no active ingredients.

What is already known about the treatment

CICR-NAM (Controlled-Ileocolonic-Release Nicotinamide) - An oral medication designed with a specialized delivery system that releases nicotinamide specifically in the ileocolonic region of the intestine. This investigational drug is currently being studied in Phase II/III clinical trials for treating mild to moderate ulcerative colitis, a chronic inflammatory bowel disease. The medication works by delivering nicotinamide, a form of vitamin B3, directly to the affected areas of the colon, where it may help reduce inflammation and promote healing of the intestinal lining. As a novel therapeutic approach in the field of gastroenterology, this controlled-release formulation represents a potential new treatment option that is being evaluated for both induction and maintenance therapy in ulcerative colitis patients.

Investigated diseases

Ulcerative Colitis - A chronic inflammatory bowel disease that affects the large intestine (colon) and rectum. The condition causes inflammation and ulcers in the digestive tract's innermost lining, leading to recurring episodes of abdominal pain, diarrhea, and bowel urgency. The inflammation typically begins in the rectum and can spread continuously to involve other parts of the colon. Symptoms tend to develop gradually and can range from mild to severe, with periods of active disease alternating with periods of remission. The condition may cause other symptoms such as fatigue, weight loss, and reduced appetite.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-510807-13-00Protocol codeORNATUS 1Estimated enrolment459 patientsSponsorUniversitaetsklinikum Schleswig-Holstein AöR

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