Actively Recruiting
Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) in Patients with Mild to Moderately Active Ulcerative Colitis
Led by University Hospital Schleswig-Holstein · Updated on 2024-11-06
459
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
Sponsors
U
University Hospital Schleswig-Holstein
Lead Sponsor
C
Ced Service GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) in Patients with Mild to Moderately Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients with ulcerative colitis aged 18 to 80 years at consent
- Ability to understand and follow study procedures
- Signed informed consent
- Diagnosed with ulcerative colitis for at least 3 months with at least 1 relapse in the last 12 months
- Histology confirms ulcerative colitis diagnosis
- Mild to moderate disease activity at screening: modified Mayo score 4-7, endoscopic score �3�31, rectal bleeding �3�31, stool frequency �3�31
- RHI score greater than 4 at screening endoscopy
- Disease extent more than 15 cm from the anal verge at screening endoscopy
- Elevated C-reactive protein and/or fecal calprotectin levels during screening above normal range
- Full colonoscopy within one year before screening or during screening with no signs of malignancy
- Stable oral 5-aminosalicylate therapy for at least 4 weeks before screening or no recent 5-ASA use
You will not qualify if you...
- Diagnosis of Crohn's disease, microscopic colitis, ischemic colitis, radiation colitis, or indeterminate colitis
- Infectious colitis, diverticulitis, or segmental colitis associated with diverticulosis within 6 months before screening
- History or current diagnosis of complex fistulae, abscesses, or strictures with obstruction
- Severe ulcerative colitis activity (modified Mayo score greater than 7)
- Severe extraintestinal manifestations requiring special treatment
- Steroid-dependent or steroid-refractory ulcerative colitis
- Likely need for hospitalization
- Previous colonic surgery except appendectomy
- Positive stool tests for enteric pathogens or Clostridium difficile toxin at screening
- Current or past colon cancer, high-grade dysplasia, or other malignancies except fully resected skin cancers
- Moderate to severe anemia (hemoglobin less than 9 g/dL) at screening
- Moderate to severe renal impairment (glomerular filtration rate less than 60) at screening
- Bleeding or clotting disorders
- Alcohol or drug abuse within last 2 years
- Recent use of rectal 5-ASA or budesonide within 2 weeks before screening (except up to 3 single doses)
- Use of oral corticosteroids or budesonide within 4 weeks before screening
- Previous use of immunosuppressants, Janus kinase inhibitors, sphingosine-1-phosphate receptor modulators, or biologics
- Use of antibiotics or probiotics for ulcerative colitis within 6 weeks before screening
- Need for parenteral therapies for ulcerative colitis except iron infusions
- Known allergy to study drug or placebo components
- Participation in another clinical trial within 4 weeks before screening or investigational drug use within 8 weeks before screening
- Under legal supervision or guardianship
- Dependent on the investigator or sponsor
- Pregnant or breastfeeding women
- Women of childbearing potential not using effective contraception until 1 month after last dose
- Male partners of women of childbearing potential unwilling to use effective contraception until 1 month after last dose
- Inability to comply with study procedures due to language or other barriers
- Other medical conditions that make participation unsafe or unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Universitaetsklinikum Schleswig-Holstein AöR
Kiel, Schleswig-Holstein, Germany, 24105
Actively Recruiting
Research Team
S
Stefan Schreiber, Prof. Dr. Dr. hc.
CONTACT
F
Friso Muijsers
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here