Oxford patient is world’s first participant in trial of new treatment for microscopic colitis

Gastroenterology researchers at Oxford University Hospitals have recruited the first person in the world to a clinical trial testing a potential new drug to treat microscopic colitis, a form of inflammatory bowel disease for which steroids are the only current treatment.

The patient is taking part in the study sponsored by the French pharmaceuticals company Sanofi-Aventis to assess the efficacy, safety and tolerability of its new SAR444336 therapy.

Microscopic colitis is an autoimmune condition that causes inflammation of the large intestine, leading to debilitating symptoms for patients, including diarrhoea, abdominal pain and digestive problems.

The usual treatment for patients with this condition is steroids, which can be effective in the short term, but half of patients will relapse, requiring repeated courses of steroids.

OUH gastroenterology consultant Dr Michael FitzPatrick, who is leading the study in Oxford, said: “Microscopic colitis is an underserved and understudied condition, with no licensed drugs other than steroids. 

“Oxford has a long history of clinical research in inflammatory bowel disease, and we are now focusing our research efforts on microscopic colitis. We are proud to have recorded this global first in this clinical trial, which aims to test a novel therapy to prevent relapse in microscopic colitis patients and keep them in long-term clinical remission without the need for long-term steroid treatment.”

This is a randomised, double-blind, placebo-controlled, parallel group study, meaning that participants are randomly assigned to two groups, only one of which receives the new treatment, while the other receives a placebo. The researchers do not know who is in each group.

Dr FitzPatrick said “I’d like to thank the gastroenterology research team at the Clinical Trials Facility, who did a fantastic job setting up and recruiting for the trial.”