Trials / Recruiting
RecruitingNCT06488625
Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) in Patients with Mild to Moderately Active Ulcerative Colitis
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
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 459 (estimated)
- Sponsor
- University Hospital Schleswig-Holstein · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
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 maintenance period. Patients will be randomised 1:1:1 placebo vs. 2 g/d CICR-NAM vs. 3 g/d CICR-NAM prior to induction treatment and will remain in the allocated dose level in the maintenance period, which results in a 52-week treatment in a treat-through design. An optional open label arm with 3 g/d CICR-NAM will be implemented for patients that have completed the induction period and show worsening of disease activity at the end of the induction period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Low-Dose CICR-NAM | 2 g/d CICR-NAM (blinded) |
| DRUG | High-Dose CICR-NAM | 3 g/d CICR-NAM (blinded) |
| DRUG | 0 g/d CICR-NAM (blinded) | Placebo (blinded) |
| DRUG | Open-Label | 3 g/d CICR-NAM (open label) |
Timeline
- Start date
- 2024-09-12
- Primary completion
- 2027-10-01
- Completion
- 2027-12-01
- First posted
- 2024-07-05
- Last updated
- 2024-11-06
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT06488625. Inclusion in this directory is not an endorsement.