Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) in Patients with Mild to Moderately Active Ulcerative Colitis

PHASE2/PHASE3RecruitingINTERVENTIONAL

Enrollment

459

Participants

Timeline

Start Date

September 12, 2024

Primary Completion Date

October 31, 2027

Study Completion Date

December 31, 2027

Conditions

Ulcerative Colitis, Unspecified

Interventions

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)

Trial Locations (1)

RECRUITING

Universitaetsklinikum Schleswig-Holstein AöR, Kiel

All Listed Sponsors

collaborator

Ced Service GmbH

OTHER

collaborator

Gesellschaft für Therapieforschung mbH

INDUSTRY

collaborator

German Federal Ministry of Education and Research

OTHER_GOV

lead

University Hospital Schleswig-Holstein

OTHER