- A Phase 3 trial dubbed Revolve and the extension trial known as Sustain will discontinue. A third trial in Crohn's disease, a Phase 3 study called Define, will not be initiated. The trials involved the drug known as mongersen.
Celgene announces that the GED-0301 phase III REVOLVE trial in Crohn's disease and the extension trial will discontinue following recommendation from Data Monitoring Committee
Celgene has decided to stop the trials following an October recommendation of the Data Monitoring Committee, which assessed overall benefit/risk during a recent interim futility analysis. There were no meaningful safety imbalances identified in the analysis.
- At this time, the phase III DEFINE trial (CD-003) in Crohn's disease will not be initiated. Celgene is waiting to review the full dataset from the phase II trial with GED-0301 in ulcerative colitis (UC) to determine next steps.
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