Status:
RECRUITING
Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) in Patients with Mild to Moderately Active Ulcerative Colitis
Lead Sponsor:
University Hospital Schleswig-Holstein
Collaborating Sponsors:
Ced Service GmbH
Gesellschaft für Therapieforschung mbH
Conditions:
Ulcerative Colitis, Unspecified
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
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) ...
Detailed Description
ORNATUS 1 is a double-blind randomised trial evaluating the efficacy and safety of CICR-NAM in patients with mild to moderately active UC. The trial includes a 12-week induction period and a 40-week m...
Eligibility Criteria
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-aminosalicylate (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 and should be stable ≥ 4 weeks before screening endoscopy with ≤ 3 g/d (up to 3 days with \> 3 g/d acceptable). 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
September 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
459 Patients enrolled
Trial Details
Trial ID
NCT06488625
Start Date
September 12 2024
End Date
December 1 2027
Last Update
November 6 2024
Active Locations (1)
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1
Universitaetsklinikum Schleswig-Holstein AöR
Kiel, Schleswig-Holstein, Germany, 24105