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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.
This study was an open-label, proof of concept to assess the safety, and efficacy of a new compound in patients with active mild-to-moderate ulcerative colitis (UC).
The predominant innovation in the study was the oral administration of the compound (compared to injections), once a day for 8 weeks.

Study challenges

Only a small number of subjects had been recruited after five months across seven sites, – far below expectations. Besides the low prevalence of UC (0.037% - 0.24%), the main challenge was a combination of active competitive studies and the disease’s highly random flare-ups. Patients were easiest to recruit during the flare-up period, at which point their primary physician would recommend beginning treatment with steroids, which was an exclusion criterion for this study. In addition, eligible patients could not have received any vaccinations in the four weeks leading up to enrollment, and as UC is an autoimmune disease, patients often receive routine vaccinations against illnesses such as influenza, chickenpox, pneumonia and others.

Strategy

nRollmed’s strategy was to target potential patients located in the relevant geographical proximity to the trial sites, focusing on both the patients and their caregivers. A professional campaign was needed to attract the relevant patients (due to the low prevalence, specific timing of flare-ups and I/E criteria). An influx of patients to the sites was needed to attract the attention and focus of the sites, to overcome the sponsor’s concern regarding competing trials.

Campaign results

50% of the patients were recruited as a direct result of nRollmed’s three month participation in the study. Bringing the study to the forefront of the sites’ priorities proved highly successful. Recruitment continued at a fast pace in tandem with the nRollmed campaign, and was successfully completed to the full satisfaction of the sponsor.