Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488625
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-26
Brief Title:
Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide CICR-NAM
Sponsor:
University Hospital Schleswig-Holstein
Organization:
University Hospital Schleswig-Holstein
Study Overview
Official Title:
A Phase IIIII 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:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Double-blind randomised placebo-controlled phase II III trial evaluating efficacy and safety of two different doses 2 gd or 3 gd 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
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 111 placebo vs 2 gd CICR-NAM vs 3 gd 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 gd 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None