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

ConditionUlcerative Colitis, Unspecified
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital Schleswig-Holstein

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female patients with UC and 18 to 80 years of age (at the time of signing the informed consent).

Ability to understand and comply with the protocol.

Signed written informed consent.

Documented diagnosis of UC, with a minimum disease duration of 3 months prior to screening and ≥ 1 relapse, clinically defined using established criteria within the last 12 months.

Disqualifiers

Diagnosis of CD, microscopic colitis, ischaemic colitis, radiation colitis or indeterminate colitis.

Infectious colitis, diverticulitis or segmental colitis associated with diverticulosis (SCAD) within the last 6 months before screening.

Current or past diagnosis of complex fistulae, intra-abdominal or peritoneal abscesses, strictures with obstructive symptoms.

Severe UC disease activity (modified Mayo score >7).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low-Dose CICR-NAM

    Drug

    2 g/d CICR-NAM (blinded)

  • High-Dose CICR-NAM

    Drug

    3 g/d CICR-NAM (blinded)

  • 0 g/d CICR-NAM (blinded)

    Drug

    Placebo (blinded)

  • Open-Label

    Drug

    3 g/d CICR-NAM (open label)

Treatment groups

459 Participants
are divided into 4 treatment groups
Group A: Low-Dose (2 g/d CICR-NAM (blinded))Experimental treatment 1 intervention
Group B: High-Dose (3 g/d CICR-NAM (blinded))Experimental treatment 1 intervention
Group C: Placebo (0 g/d CICR-NAM (blinded))Placebo comparator 1 intervention
Group D: Open-Label (3 g/d CICR-NAM (blinded))Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Schleswig-Holstein

Lead sponsor

Gesellschaft für Therapieforschung mbH

Collaborator

Funded by the German Federal Ministry of Research, Technology and Space (01KG2006)

Collaborator

Ced Service GmbH

Collaborator

Source ClinicalTrials.gov
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