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

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510807-13-00

Acronym

ORNATUS 1

Enrollment

459

Registered

2024-04-09

Start date

2024-09-12

Completion date

Unknown

Last updated

2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ulcerative colitis

Brief summary

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)).

Detailed description

Symptomatic remission at Week 52., Endoscopic remission at Week 52., Symptomatic response at Week 12., Endoscopic response and/or histologic improvement at Week 12., Clinical remission at Week 52 in responders at Week 12., Symptomatic remission at Week 12., Endoscopic healing at Week 52., Histologic improvement at Week 12.

Interventions

DRUGCICR-NAM

DRUGCICR-NAM Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Symptomatic remission at Week 52., Endoscopic remission at Week 52., Symptomatic response at Week 12., Endoscopic response and/or histologic improvement at Week 12., Clinical remission at Week 52 in responders at Week 12., Symptomatic remission at Week 12., Endoscopic healing at Week 52., Histologic improvement at Week 12.	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026