Provention Bio, Inc. recently announced top-line results with its drug candidate PRV-300 for the treatment of ulcerative colitis.

The Phase Ib PHASE clinical trial, which included 37 patients at three sites, met its primary safety and tolerability endpoints. An analysis of this trial and all other ulcerative colitis trials can be found in the Clinical Trials Database of GlobalData’s Pharma Intelligence Center. In this article, a small number of Phase 0, Phase I/II, Phase II/III, and Phase III/IV trials were combined with Phase I, Phase II, Phase III, and Phase IV trials, respectively.

Looking back at clinical trials that started in the last five years, 2016 had the most clinical trials, with about 22.4%, followed by 2018 (20.6%) and 2017 (19.6%) (Figure 1). Breaking down these trials further by trial status shows that the majority of trials have been completed, followed by ongoing, recruiting and suspended/terminated/withdrawn (S/T/W) (Figure 2).

Phase II clinical trials make up almost half of all clinical trials in the Clinical Trials Database, at 42.8%, followed by Phase I, Phase IV, Phase III, and Phase O (Figure 3). Breaking down trials by single country versus multinational, single country outnumbers multinational in all trial phases (Figure 4).