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Tests treatment safety and results for Ulcerative Colitis, Unspecified
Official title Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) in Patients With Mild to Moderately Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT06488625
What this study is testing
What is Low-Dose CICR-NAM?
Low-Dose CICR-NAM is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ulcerative colitis, unspecified.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
You likely can't join 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.
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kiel, Schleswig-Holstein, Germany
- Aachen, Germany
- Augsburg, Germany
- Bamberg, Germany
- Berlin, Germany
- Bremen, Germany
- Cologne, Germany
- Dachau, Germany
- Darmstadt, Germany
- Dornstadt, Germany
- Dresden, Germany
- Frankfurt, Germany
- Frankfurt am Main, Germany
- Halle, Germany
- Hamburg, Germany
- Hamm, Germany
- Hanover, Germany
- Heidelberg, Germany
- Ludwigshafen, Germany
- Lübeck, Germany
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kiel, Schleswig-Holstein, Germany; Aachen, Germany; Augsburg, Germany; Bamberg, Germany; Berlin, Germany; Bremen, Germany and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.