A trial to evaluate the efficacy and safety of oral controlled-ileocolonic-release nicotinamide (CICR-NAM) in patients with mild to moderately active ulcerative colitis
- Conditions
- ulcerative colitisMedDRA version: 20.0Level: PTClassification code: 10009900Term: Colitis ulcerative Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2024-510807-13-00
- Lead Sponsor
- niversitaetsklinikum Schleswig-Holstein AöR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 459
Male and female patients with UC and 18 to 80 years of age (at the time of signing the informed consent)., 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., Mild to moderate disease activity (at screening): modified Mayo score 4–7 with Mayo rectal bleeding (RB) subscore = 1, Mayo endoscopic score (ES) subscore = 1 and Mayo stool frequency (SF) subscore = 1., Robarts Histology Index > 4 (at screening endoscopy)., Disease extent >15 cm from the anal verge (at screening endoscopy)., 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 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
Diagnosis of Crohn`s disease, microscopic colitis, ischaemic colitis, radiation colitis or indeterminate colitis., Pregnant or breastfeeding women., 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., 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to assess the efficacy of CICR-NAM on symptomatic remission and endoscopic response and/or histologic improvement after 12 weeks and on clinical remission after 52 weeks in patients with mildly to moderately active ulcerative colitis (UC).;Secondary Objective: The key secondary objectives are to assess the efficacy of CICR-NAM on clinical remission, symptomatic remission, endoscopic response and remission, endoscopic response and/or histologic/biomarker improvement and endoscopic healing in patients with mildly to moderately active UC at timepoints up to 52 weeks of treatment.;Primary end point(s): Symptomatic remission and endoscopic response and/or histologic improvement at Week 12., Clinical remission at Week 52 (for patients with a constant Mayo ES = 1 from baseline, this requires an objective second marker of improvement (histologic improvement to RHI = 4)).
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Symptomatic remission at Week 52.;Secondary end point(s):Endoscopic remission at Week 52.;Secondary end point(s):Symptomatic response at Week 12.;Secondary end point(s):Endoscopic response and/or histologic improvement at Week 12.;Secondary end point(s):Clinical remission at Week 52 in responders at Week 12.;Secondary end point(s):Symptomatic remission at Week 12.;Secondary end point(s):Endoscopic healing at Week 52.;Secondary end point(s):Histologic improvement at Week 12.