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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
459
2 g/d CICR-NAM (blinded)
3 g/d CICR-NAM (blinded)
Placebo (blinded)
3 g/d CICR-NAM (open label)
Universitaetsklinikum Schleswig-Holstein AöR
Kiel, Schleswig-Holstein, Germany
RECRUITINGUniversitaetsklinikum Aachen AöR
Aachen, Germany
NOT_YET_RECRUITINGUniversitaetsklinikum Augsburg
Augsburg, Germany
RECRUITINGSozialstiftung Bamberg
Bamberg, Germany
Symptomatic remission
The proportion of subjects that show symptomatic remission. Symptomatic remission is achieved if: Mayo SF = 0 or 1 (and SF no greater than baseline) and Mayo RB = 0 as well as a reduction from Mayo ES = 2 or 3 at baseline by at least one point or a reduction from Mayo ES = 1 at baseline to Mayo ES = 0 or, in case of a constant Mayo ES = 1 from baseline, an objective second marker of improvement (histologic improvement to RHI ≤ 4)
Time frame: Baseline - Week 12
Clinical remission
The proportion of subjects that show clincial remission. Clinical remission is achieved if: Mayo SF = 0 (or SF = 1 with a ≥ 1-point decrease from baseline), Mayo RB = 0, and Mayo ES ≤ 1 (excluding friability) (for constant Mayo ES = 1 from baseline, histologic improvement to RHI ≤ 4)
Time frame: Baseline - Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
RECRUITINGCharite Universitaetsmedizin Berlin KöR
Berlin, Germany
RECRUITINGDRK Kliniken Berlin
Berlin, Germany
RECRUITINGGesundheit Nord gGmbH Klinikverbund Bremen
Bremen, Germany
RECRUITINGEvangelisches Krankenhaus Kalk gGmbH
Cologne, Germany
RECRUITINGMedical Care Unit Dachau
Dachau, Germany
WITHDRAWN...and 16 more locations