We have just completed the Bandit trial, a placebo-controlled trial to investigate the safety and efficacy of baricitinib in individuals with recent-onset type 1diabetes. The primary objective to determine if baricitinib can reduce the loss of meal-stimulated C-peptide, a measure of beta-cell function, was met. This trial will be followed by other trials of JAK inhibitors if it is successful and also by trials of other therapies.
Trials like Bandit produce large amounts of patient data with numerous immunological and metabolic parameters and numerous aliquots of plasma and peripheral blood mononuclear cells, the term used for preparations of lymphocytes and monocytes isolated from blood. Some of the challenges we recognise include being able to measure disease activity in order to titrate immunotherapy or add new agents in the event of a flare of disease.
Are there cellular patterns or cytokine levels in blood that can guide this in the absence of clinical features that indicate disease activity in other autoimmune diseases. Does a concurrent medical event like the Covid-19 pandemic affect a trial. These are the kinds of questions that can be tested.