Image

Ulcerative Colitis

About the Ulcerative Colitis Study

An Open Label, Proof of Concept Study to assess the safety, PK and explore efficacy a new compound in Patients with active mild-to-moderate Ulcerative Colitis.
One of the main innovation in the study was the oral administration of the compound (compared to injections), once a day for 8 weeks.

Study challenges

Although the early phase of the study, the recruitment goal was not achieved via the 7 sites involved. After 5 months, only a small number of subjects have been recruited, far below the expectations. Beyond the low prevalence of the UC indication (0.037% - 0.24%), the main challenge was a combination between available competitive studies and the disease random flare-ups. Patients are usually recruited during flare-ups and thus are recommended to start a treatment with steroids, which is an exclusion criterion for this study or join competitive phase III studies. In addition, as UC is an autoimmune disease, patients often receive vaccinations against disease such as Influenza, chickenpox, Pneumonia, etc. Eligible patients can't receive any vaccination 4 weeks prior enrollment.

Strategy

nRollmed strategy was to target potential patients located in the relevant proximity to the trial sites, focusing specifically on potential patients and their care givers (parents, family members), who are suffering from Mild-to-Moderate UC. A very professional and accurate campaign was needed to attract the relevant patients (due to the low prevalence and I/E criteria) and put this study in the focus of the sites, to overcome the issue of competitive trials.

Campaign results

nRollmed participated in the study for 3 months until recruitment was completed, during which 50% of the patients were recruited directly as a result of the campaign. The goal to bring the study to the foreground attention of the sites was highly successful and a substantial positive impact on sites' performance was achieved. Thus, recruitment continue vigorously via the sites in parallel to nRollmed campaign, and successfully completed shortly after, to the full satisfaction of the sponsor.