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

Exclusion Criteria

• •General health and UC:
• •1. Diagnosis of CD, microscopic colitis, ischaemic colitis, radiation colitis or indeterminate colitis.
• •2. Infectious colitis, diverticulitis or segmental colitis associated with diverticulosis (SCAD) within the last 6 months before screening.
• •3. Current or past diagnosis of complex fistulae, intra-abdominal or peritoneal abscesses, strictures with obstructive symptoms.
• •4. Severe UC disease activity (modified Mayo score \>7).
• •5. Severe extraintestinal manifestations of UC requiring special treatment.
• •6. Steroid-dependent or steroid-refractory UC.
• •7. Foreseeable need for hospitalisation.
• •8. Previous colonic surgery, except for appendectomy.
• •9. Stools positive for enteric pathogens; Clostridium difficile toxin (CDT)-positive infection; indications for other relevant infections including cytomegalovirus colitis, each at screening.
• •10. Current or history of colon carcinoma, high grade colonic dysplasia or other malignancies except for completely resected basal cell carcinoma and squamous cell carcinoma of the skin.
• •11. Moderate to severe anaemia (haemoglobin \<9 g/dL) at screening.
• •12. Moderate to severe renal impairment (glomerular filtration rate \<60) at screening.
• •13. Relevant bleeding or thrombotic disorders.
• •14. Alcohol or drug abuse within the last 2 years.
• •Medications:
• •15. 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).
• •16. Use of oral corticosteroids and/or oral budesonide ≤ 4 weeks prior to screening endoscopy.
• •17. Previous use of immunosuppressants, Janus kinase inhibitors, sphingoside-1-phosphate receptor modulators or biologics.
• •18. Use of antibiotics for the treatment of UC or probiotic medication within 6 weeks prior to screening endoscopy.
• •19. Any need of parenteral therapies for the therapy of UC (except iron infusions).
• •20. Known hypersensitivity towards any component of the CICR-NAM or placebo tablets.
• •Regulatory requirements
• •21. Participation in a clinical trial within 4 weeks prior to screening for this trial or intake of an investigational medicinal product (IMP) within the last 8 weeks or 5 half-lives (whichever is longer) prior to screening (or longer if necessary in the investigator's discretion).
• •22. Patients under legal supervision or guardianship, including patients, who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
• •23. Patients who are dependent on the investigator or the sponsor.
• •Other:
• •24. Pregnant or breastfeeding women.
• •25. Women of childbearing potential (WoCBP) not using highly effective contraception till at least 1 month after last dosing of IMP.
• •26. Male participants with female partners of childbearing potential who are not willing to use a highly effective contraception till at least 1 month after last dosing of IMP.
• •27. Indications that the patient may be unable to comply with the trial procedures, e.g. language barriers precluding adequate understanding or cooperation.
• •28. Any circumstances or medical conditions which could contradict a trial participation and lead the investigator to assess the patient as unsuitable for trial participation for any other reason.