Clinical trial • Phase II/III • Gastroenterology

Nicotinamide for Ulcerative colitis

Phase II/III trial of Nicotinamide for Ulcerative colitis. CTIS 2024-510807-13-00.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Ulcerative colitis
Trial Stage
Phase II/III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
07-02-2024
First CTIS Authorization Date
09-04-2024

Trial design

Randomised, cicr-nam placebo (matching placebo arm). active investigational product: cicr-nam (oral controlled-ileocolonic-release nicotinamide film-coated tablet); product information indicates a maximum daily dose of 3 g (dose unit g) but specific dosing regimen/schedule for randomised arms not detailed in the provided record. Phase II/III trial across 24 sites in Germany.

Randomised
Yes
Comparator
CICR-NAM Placebo (matching placebo arm). Active investigational product: CICR-NAM (oral controlled-ileocolonic-release nicotinamide film-coated tablet); product information indicates a maximum daily dose of 3 g (dose unit g) but specific dosing regimen/schedule for randomised arms not detailed in the provided record.
Target Sample Size
459
Trial Duration For Participant
364

Eligibility

Recruits 459 No vulnerable population selected. Participants are adults aged 18 to 80. Subject information and informed consent forms are provided (see listed ICF/SIS documents); consent is to be obtained from each participant (no assent arrangements described since minors are excluded)..

Pregnancy Exclusion
Pregnant or breastfeeding women.
Vulnerable Population
No vulnerable population selected. Participants are adults aged 18 to 80. Subject information and informed consent forms are provided (see listed ICF/SIS documents); consent is to be obtained from each participant (no assent arrangements described since minors are excluded).

Inclusion criteria

  • {"criterion_text":"- Male and female patients with UC and 18 to 80 years of age (at the time of signing the informed consent).\n- 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.\n- Mild to moderate disease activity (at screening): modified Mayo score 4–7 with Mayo rectal bleeding (RB) subscore ≥ 1, Mayo endoscopic score (ES) subscore ≥ 1 and Mayo stool frequency (SF) subscore ≥ 1.\n- Robarts Histology Index > 4 (at screening endoscopy).\n- Disease extent >15 cm from the anal verge (at screening endoscopy).\n- In the case of no oral 5-ASA therapy within the last 2 weeks before entry into screening with informed consent, any prior oral 5-ASA therapy is permitted and the patient is not allowed to receive 5-ASA during the study. In the case of oral 5-ASA therapy within 2 weeks before entry into screening with informed consent, the 5-ASA therapy should have been ongoing for > 3 months, should not be increased ≥ 4 weeks before screening endoscopy and should remain stable for ≥ 1 week before screening endoscopy at the maximum dose according to label or lower. This 5-ASA baseline medication must be kept stable in the induction period and may be reduced (but not increased again) in the maintenance period. In cases in which 5-ASA is dosed higher than the approved dose, the dose will be adjusted to the maximum approved dose at the time of randomization."}

Exclusion criteria

  • {"criterion_text":"- Diagnosis of Crohn`s disease, microscopic colitis, ischaemic colitis, radiation colitis or indeterminate colitis.\n- Pregnant or breastfeeding women.\n- Infectious colitis, diverticulitis or segmental colitis associated with diverticulosis (SCAD) within the last 6 months before screening.\n- Current or past diagnosis of complex fistulae, intra-abdominal or peritoneal abscesses, strictures with obstructive symptoms.\n- Severe UC disease activity (modified Mayo score >7).\n- Severe extraintestinal manifestations of UC requiring special treatment.\n- Steroid-dependent or steroid-refractory UC.\n- Rectal topical 5-ASA and/or rectal budesonide therapy (enemas, foams or suppositories) ≤ 2 weeks prior to screening endoscopy (up to 3 single doses allowed).\n- Use of oral corticosteroids and/or oral budesonide ≤ 4 weeks prior to screening endoscopy.\n- Previous use of immunosuppressants, Janus kinase inhibitors, sphingoside-1-phosphate receptor modulators or biologics."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Symptomatic remission and endoscopic response and/or histologic improvement at Week 12.","definition_or_measurement_approach":"Assessed at Week 12; symptomatic remission and endoscopic response and/or histologic improvement measured by modified Mayo score components, endoscopy (Mayo endoscopic score) and histology (e.g., Robarts Histology Index)."}
  • {"endpoint_text":"- 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)).","definition_or_measurement_approach":"Assessed at Week 52; clinical remission per Mayo score criteria; patients with constant Mayo ES = 1 require histologic improvement defined as Robarts Histology Index ≤ 4 as an objective second marker."}

Secondary endpoints

  • {"endpoint_text":"- Symptomatic remission at Week 52.","definition_or_measurement_approach":"Assessed at Week 52 using symptomatic components (e.g., stool frequency and rectal bleeding subscores)."}
  • {"endpoint_text":"- Endoscopic remission at Week 52.","definition_or_measurement_approach":"Assessed at Week 52 by endoscopy (Mayo endoscopic score criteria)."}
  • {"endpoint_text":"- Symptomatic response at Week 12.","definition_or_measurement_approach":"Assessed at Week 12 using symptomatic measures (modified Mayo score subscores)."}
  • {"endpoint_text":"- Endoscopic response and/or histologic improvement at Week 12.","definition_or_measurement_approach":"Assessed at Week 12 by endoscopy and histology measures (Mayo endoscopic score and histologic indices)."}
  • {"endpoint_text":"- Clinical remission at Week 52 in responders at Week 12.","definition_or_measurement_approach":"Assessed at Week 52 among Week 12 responders using clinical remission criteria (Mayo score)."}
  • {"endpoint_text":"- Symptomatic remission at Week 12.","definition_or_measurement_approach":"Assessed at Week 12 using symptomatic subscores of the modified Mayo score."}
  • {"endpoint_text":"- Endoscopic healing at Week 52.","definition_or_measurement_approach":"Assessed at Week 52 by endoscopic evaluation (Mayo endoscopic score indicating healing)."}
  • {"endpoint_text":"- Histologic improvement at Week 12.","definition_or_measurement_approach":"Assessed at Week 12 by histologic indices (e.g., Robarts Histology Index)."}

Recruitment

Registry Or Advocacy Recruitment
True, Sozialstiftung Bamberg (listed as a trial site and patient organisation/association).
Digital Remote Recruitment
True — recruitment materials include a patient web page and online advertisements (documents listed: K2_..._web page patients; K2 advertisements).
Planned Sample Size
459
Recruitment Window Months
40
Consent Approach
Informed consent to be obtained from each participating adult (participants aged 18 to 80). Subject information and informed consent form documents are listed (e.g., L1_SIS and ICF 2024-510807-13-00 public; L2 patient-facing documents). No assent process described (minors excluded). Languages of ICFs not specified in the provided record.

Methods

  • Recruitment material flyer (document: K2_ Recruitment material flyer) — targeted at patients with ulcerative colitis; country: Germany.
  • Recruitment material advertisements (documents: K2_... advertisement 1, advertisement 2) — advertisements likely for patient audience; country: Germany.
  • Recruitment material web page for patients (document: K2_..._web page patients) — online patient-facing information; country: Germany.
  • Recruitment material poster (document: K2_ Recruitment material poster_A3...) — clinic/site posters for patient recruitment; country: Germany.
  • Recruitment material transcript (document: K2_..._transcript) — supporting recruitment communications; country: Germany.

Geography

Total Number Of Sites
24
Total Number Of Participants
459

Germany

Earliest CTIS Part Ii Submission Date
27-03-2024
Latest Decision Or Authorization Date
17-12-2025
Processing Time Days
630
Number Of Sites
24
Number Of Participants
459

Sites

Site Name
Private Practice for Gastroenterology
Department Name
Practice for Gastroenterology
Contact Person Name
Robert Ehehalt
Contact Person Email
re@hd-gastro.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Med. Department of Gastroenterology, Infectiology and Rheumatology
Contact Person Name
Britta Siegmund
Contact Person Email
britta.siegmund@charite.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Medizinische Klinik und Poliklinik I
Contact Person Name
Renate Schmelz
Contact Person Email
schmelz.studien@ukdd.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Centre for Internal Medicine, Internal Medicine 1
Contact Person Name
Jochen Klaus
Contact Person Email
jochen.klaus@uniklinik-ulm.de
Site Name
Medical Care Unit Dachau
Department Name
Practice for Gastroenterology
Contact Person Name
Wilfred Landry
Contact Person Email
landry@dachau-med.de
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Medizinische Klinik II
Contact Person Name
Johann Ockenga
Site Name
Practice for Gastroenterology
Department Name
Practice for Gastroenterology
Contact Person Name
Jens Seiger
Contact Person Email
seiger@gastro-han.de
Site Name
Gastropraxis Magdeburg
Department Name
Gastropraxis Magdeburg
Contact Person Name
Lars Zimmermann
Contact Person Email
zimmermann@gastropraxis-md.de
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik 1
Contact Person Name
Irina Blumenstein
Site Name
Gastroenterologische Schwerpunktpraxis Prof. Dr. Ludwig & Dr. med. Güthle
Department Name
Gastroenterologische Schwerpunktpraxis Prof. Dr. Ludwig & Dr. med. Güthle
Contact Person Name
Leopold Ludwig
Contact Person Email
l.ludwig@praxis-endoskopie.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Department for Internal Medicine I
Contact Person Name
Susanna Nikolaus
Contact Person Email
s.nikolaus@mucosa.de
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Clinic and polyclinic for internal medicine I
Contact Person Name
Jens Walldorf
Contact Person Email
jens.walldorf@uk-halle.de
Site Name
DRK Kliniken Berlin
Department Name
Clinic for Internal Medicine - Gastroenterology, Hematology and Oncology, Nephrology
Contact Person Name
Benjamin Moser
Contact Person Email
b.moser@drk-kliniken-berlin.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
Contact Person Name
Thomas Vasilakis
Contact Person Email
thomas.vasilakis@charite.de
Site Name
Evangelisches Krankenhaus Kalk gGmbH
Department Name
Gastroenterologie, Pneumologie und Allgemeine Innere Medizin
Contact Person Name
Kondrad Streetz
Contact Person Email
konrad.streetz@evkk.de
Site Name
Gastroenterologie am Herrengarten
Department Name
Gastroenterologie am Herrengarten
Contact Person Name
Jörg Carl Hoffmann
Site Name
Universitat Heidelberg
Department Name
II Medical Clinic
Contact Person Name
Anne Thomann
Site Name
Sozialstiftung Bamberg
Department Name
Department of Internal and Integrative Medicine
Contact Person Name
Jost Langhorst
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medical Clinic I
Contact Person Name
Philipp Solbach
Contact Person Email
philipp.solbach@uksh.de
Site Name
St. Marien Und St. Annastiftskrankenhaus
Department Name
Clinic for Internal Medicine, Gastroenterology, Cardiology, Pneumology, Palliative Medicine, Diabeto
Contact Person Name
Tanja Kühbacher
Site Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name
Department of Medicine I
Contact Person Name
Axel Dignaß
Contact Person Email
axel.dignass@agaplesion.de
Site Name
Universitaetsklinikum Augsburg
Department Name
III. Medical Clinic, Gastroenterology
Contact Person Name
Elisabeth Schnoy
Contact Person Email
studie-3.med@uk-augsburg.de
Site Name
Gastropraxis an der St. Barbara-Klinik
Department Name
Gastropraxis an der St. Barbara Klinik
Contact Person Name
Frank Lenze
Contact Person Email
lenze@gastro-praxis-hamm.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
I. Medical Clinic and Polyclinic
Contact Person Name
Thorben Fründt
Contact Person Email
t.fruendt@uke.de

Sponsor

Primary sponsor

Full Name
Universitaetsklinikum Schleswig-Holstein AöR
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
CICR-NAM
Active Substance
Nicotinamide
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Investigational (not marketing authorised)
Maximum Dose
3 g per day
Investigational Product Name
CICR-NAM Placebo
Modality
Other
Authorisation Status
Not applicable

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