Immunic Therapeutics, is a clinical-stage biopharmaceutical company specialising in immunological therapies focused on treating chronic inflammatory and autoimmune diseases. They are currently researching the safety and tolerability of an oral therapy IMU-856, at four clinical research sites in New Zealand, based in Auckland, Hawke's Bay, Palmerston North, and Wellington. IMU-856 is proposed to have the potential to facilitate mucosal recovery followed by symptom relief and thereby improve quality of life.
There are two screening visits for this trial to determine eligibility for participation. The second visit will last approximately 4 hours and will involve an assessment of the participants general health and an endoscopy involving biopsies of the small intestine. This routine procedure performed by a Gastroenterologist is usually painless and performed under light sedation. Clinically diagnosed coeliac patients would have undergone this procedure before.
This clinical trial is a placebo-controlled double-blind trial, meaning neither the medical team or the participants will know whether they will be taking IMU856, of which there is a 67% chance or Placebo a 33% chance. The treatment arms are randomly assigned using a randomisation number system.
The trial will involve a participation period of 84 days. This includes a screening period of 28 days involving 2 visits to the study site. The treatment period involves taking a daily dose of IMU-865 for 28 days, during which there will be 6 visits to the study site, where participants will undergo a medical examination, blood and urine sampling and clinical assessments such as ECG and vital sign measurements. On day14 of the trial participants will visit the trial site, after a dose of IMU-856 they will embark on a 14 day gluten challenge. Day 14 will involve an 8 hour visit and will be the first day of the gluten challenge which will be performed under medical supervision at the clinical site as a day visit. The procedures and length of visit at the clinical site will vary between 1 - 8 hours depending on the assessments and procedure to be performed.
On Day 29 the participant will undergo a second endoscopy where small tissue samples will be taken to measure physiologic characteristics of the intestine and to monitor the status of the gut lining. Participants will also be required to complete disease specific questionnaires during the trial and keep a diary, recording at home dose administration and any side effects the participants may experience. The follow up period of this trial will last for 28 days, involving one visit to the clinic site on Day 56.
Eligible participants for this study will need to be:
Participants' time in this study will be remunerated. Individuals interested in participating in this trial to help develop therapies for coeliac disease can register their interest on the Evrima website, this link https://trials.evrima.com.au/coeliac-disease-medical-study will take them to the study recruitment page on the website.