We very much appreciate your interest in our ongoing research to find new therapies for inflammatory bowel disease (IBD), and in particular ulcerative colitis or Crohn’s disease. If you are a patient suffering from ulcerative colitis or Crohn’s disease, you may have experienced flare-ups despite being adequately treated by your physician. For this reason, the company Immunic is investigating new therapies that work differently in the body. We believe that this may potentially offer a new therapy for IBD patients. However, this is an investigational drug, meaning we have not confirmed a beneficial effect in IBD patients yet and are still investigating this drug in clinical trials. Not all risks of this drug may be known yet, however more than 300 patients and volunteers have received the active drug contained in IMU-838 and the tolerance profile from these investigations is known.
There has been a small trial (total of 34 corticosteroid-dependent patients) where the active drug in IMU-838 has been investigated in IBD patients (roughly half were patients suffering from ulcerative colitis and Crohn’s disease, respectively). The study has shown that a vast majority of these patients had beneficial effects in this trial. However, this was a particular patient population and the result of this trial may not be transferrable to your situation.
This is a Phase 2 trial. This means it evaluates this drug (IMU-838) in different doses to investigate what the best dose will be to treat IBD patients. The best dose should be effective and tolerable for the patient. The study also uses a placebo arm (about 25-33% of patients in this trial receive placebo). You are randomized and blinded, ie, you may not know that you are receiving IMU-838 or placebo. The trial will allow that you switch to an open-label treatment arm (where you will receive IMU-838) when you fulfill certain criteria (including completing an initial 10-or 12- week treatment period).
IMU-838 is a tablet to be taken by mouth. In this trial, 1 or 2 tablets are taken once daily for the duration of the trial.
The clinical trial will involve several endoscopies to be performed. This is necessary to monitor the drug effects on the healing of your bowel.
This trial requires that you have an established diagnosis of IBD, currently have active symptoms of your disease despite being treated, and having failed several medications in the past, including other oral drugs or biologics.