So this pilot study is based on influencing the so-called plasma cells, which are cells in the immune system that are primarily responsible for creating antibodies. And we give a medicine called Daratumumab, which is an antibody that is used in cancer treatment for patients who have so-called myelomatosis or bone marrow cancer, because it lowers the level of these plasma cells, also benign plasma cells. So when we use it, the purpose is to temporarily reduce the number of plasma cells in the system and then, as a result, the antibody levels in the blood are temporarily reduced. And then we hope that the effect can be sustained in some patients, so that when those antibodies are reduced, it leads to an improvement in the patients' symptoms.
And what we have seen in the pilot study is that 60% of those, that is, 6 out of 10 patients that we have included, have apparently had a good effect on the symptoms of the disease. And of five of the six patients have experienced a clinical improvement, then the response or improvement has been sustained for up to two years, as long as we have followed the patients. One of the patients had a relatively early relapse after 3 months, a partial relapse, while the other five patients have had a sustained effect.
We haven't had any significant side effects from this. No serious medical events. So we believe that tolerance has been good so far. We have given a little over 50 such injections. And these injections are given subcutaneously, i.e. under the skin of the abdomen. And it has actually worked well. But even though we have seen that it has had a good effect in these patients, we believe that there is reason to do a larger study. And the main reason is that we cannot draw any firm conclusions based on such a small pilot study with 10 patients. We cannot be sure that the medication alone is the cause of the observed improvements.
So that's why we have to do what we call a double-blind study where some of the patients receive active medicine and some of the patients receive inactive injections without active medicine, without either us or the patient knowing what they have received. It is certainly a double-blind and placebo-controlled study. We have planned this and are thinking of starting it, hopefully before or after the summer when the studies have been approved by the authorities.
And initially we are thinking of including 66 patients, where 44 patients will receive active medicine with this Daratumumab medicine that will reduce the number of plasma cells and 22 patients on placebo, i.e. an inactive injection that does not affect the immune system. And then these patients will be followed up for three months after inclusion in the study before they receive the first injection. And then they should be followed for 15 months after they start treatment, so 18 months in total. And when the last patient has been observed for 18 months, the study is closed. And then we will know who has received active treatment and who has received placebo and can compare the results. And then we can get a relatively certain impression of whether this medication is useful for patients, if it is important that it provides good responses that last over time in a sufficiently large proportion of patients.
