RecruitingPhase 2Phase 3NCT06488625

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

Sponsor

University Hospital Schleswig-Holstein

Enrollment

459 participants

Start Date

Sep 12, 2024

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis, Unspecified

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

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral medication called CICR-NAM (a slow-release form of nicotinamide, a type of vitamin B3) in people with mild to moderately active ulcerative colitis (UC), a chronic inflammatory bowel condition. Researchers want to see if this drug is safe and can reduce inflammation in the colon. **You may be eligible if...** - You are 18 to 80 years old with a confirmed diagnosis of ulcerative colitis for at least 3 months - Your disease is mild to moderately active - You have had at least one flare-up in the past 12 months **You may NOT be eligible if...** - You are currently experiencing a very severe UC flare-up - You have Crohn's disease or other bowel conditions - You have recently used certain immunosuppressive medications - You have significant kidney, liver, or heart problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLow-Dose CICR-NAM

2 g/d CICR-NAM (blinded)

DRUGHigh-Dose CICR-NAM

3 g/d CICR-NAM (blinded)

DRUG0 g/d CICR-NAM (blinded)

Placebo (blinded)

DRUGOpen-Label

3 g/d CICR-NAM (open label)

Locations(26)

Universitaetsklinikum Schleswig-Holstein AöR

Kiel, Schleswig-Holstein, Germany

Universitaetsklinikum Aachen AöR

Aachen, Germany

Universitaetsklinikum Augsburg

Augsburg, Germany

Sozialstiftung Bamberg

Bamberg, Germany

Charite Universitaetsmedizin Berlin KöR

Berlin, Germany

Charite Universitaetsmedizin Berlin KöR

Berlin, Germany

DRK Kliniken Berlin

Berlin, Germany

Gesundheit Nord gGmbH Klinikverbund Bremen

Bremen, Germany

Evangelisches Krankenhaus Kalk gGmbH

Cologne, Germany

Medical Care Unit Dachau

Dachau, Germany

Gastroenterologie am Herrengarten

Darmstadt, Germany

Gastroenterologische Schwerpunktpraxis Prof. Dr. Ludwig & Dr. med. Güthle

Dornstadt, Germany

Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

Dresden, Germany

Goethe University Frankfurt

Frankfurt, Germany

Agaplesion Frankfurter Diakonie Kliniken gGmbH

Frankfurt am Main, Germany

Martin-Luther-Universitaet Halle-Wittenberg

Halle, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Gastropraxis an der St. Barbara-Klinik

Hamm, Germany

Practice for Gastroenterology

Hanover, Germany

Private Practice for Gastroenterology

Heidelberg, Germany

St. Marien Und St. Annastiftskrankenhaus

Ludwigshafen, Germany

Universitaetsklinikum Schleswig-Holstein AöR

Lübeck, Germany

Gastropraxis Magdeburg

Magdeburg, Germany

Universitat Heidelberg

Mannheim, Germany

Universitaet Muenster

Münster, Germany

Universitaetsklinikum Ulm AöR

Ulm, Germany

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NCT06488625