A Phase II/III, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) for Induction and Maintenance Therapy in Patients with Mild to Moderately Active Ulcerative Colitis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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) 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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

‣ 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.

Locations
Other Locations
Germany
Universitaetsklinikum Schleswig-Holstein AöR
RECRUITING
Kiel
Contact Information
Primary
Stefan Schreiber, Prof. Dr. Dr. hc.
s.schreiber@mucosa.de
+4943150022200
Backup
Friso Muijsers
info@zks.uni-kiel.de
+4943150030751
Time Frame
Start Date: 2024-09-12
Estimated Completion Date: 2027-12
Participants
Target number of participants: 459
Treatments
Experimental: Low-Dose (2 g/d CICR-NAM (blinded))
To maintain blinding for patients and investigators in the induction and maintenance treatment, all patients self-administer 6 tablets per day. In the low-dose arm, subjects receive 4 tablets of verum CICR-NAM and 2 tablets of placebo CICR-NAM per day, resulting in a total daily intake of 2 g/d CICR-NAM
Experimental: High-Dose (3 g/d CICR-NAM (blinded))
To maintain blinding for patients and investigators in the induction and maintenance treatment, all patients self-administer 6 tablets per day. In the high-dose arm, subjects receive 6 tablets of verum CICR-NAM and 0 tablets of placebo CICR-NAM per day, resulting in a total daily intake of 3 g/d CICR-NAM
Placebo_comparator: Placebo (0 g/d CICR-NAM (blinded))
To maintain blinding for patients and investigators in the induction and maintenance treatment, all patients self-administer 6 tablets per day. For the placebo arm, subjects receive 0 tablets of verum CICR-NAM and 6 tablets of placebo CICR-NAM per day, resulting in a total daily intake of 0 g/d CICR-NAM
Experimental: Open-Label (3 g/d CICR-NAM (blinded))
Patients that have completed the induction period and show worsening of disease activity at the end of the induction period will be allowed to switch to the open-label arm to receive 6 tablets of verum CICR-NAM of 0 tablets of placebo CICR-NAM per day, resulting in a total daily intake of 3 g/d CICR-NAM
Sponsors
Collaborators: Ced Service GmbH, Gesellschaft für Therapieforschung mbH, German Federal Ministry of Education and Research
Leads: University Hospital Schleswig-Holstein

This content was sourced from clinicaltrials.gov

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