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# Celgene Stops Studies in Crohn’s Disease
- URL: https://www.fdaweb.com/celgene-stops-studies-in-crohns-disease/
- Published: 2017-10-20T12:00:00.000Z
- Updated: 2026-09-14T22:57:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139926

Celgene has discontinued its Phase 3 REVOLVE trial (CD-002) in Crohn’s disease and the extension trial (SUSTAIN, CD-004) that are both studying GED-0301 (mongersen), an investigational oral antisense therapy. The company stopped the trials following a recent recommendation from its data monitoring committee, “which assessed overall benefit/risk during a recent interim futility analysis,” Celgene says.  
  
At this time, the Phase 3 DEFINE trial (CD-003) in Crohn’s disease will not be initiated, Celgene says. “Celgene is waiting to review the full [dataset](http://www.businesswire.com/news/home/20171019006519/en/Celgene-Update-GED-0301-mongersen-Inflammatory-Bowel-Disease/?feedref=JjAwJuNHiystnCoBq%5Fhl-WBlLQO14j4QZPTyX5CYOnwC4VjN53jumZRlnzhBoBxGrCOi9QzgjCezTS3Nw%5FX6kJUrpSBm-Hav1w-UkdSlG3ltkRSnqzf6ourQGu%5FUA28CzZCGORvG0LE20YOvo49uqw==&ref=fdaweb.com) from the Phase 2 trial with GED-0301 in [ulcerative colitis](http://www.businesswire.com/news/home/20171019006519/en/Celgene-Update-GED-0301-mongersen-Inflammatory-Bowel-Disease/?feedref=JjAwJuNHiystnCoBq%5Fhl-WBlLQO14j4QZPTyX5CYOnwC4VjN53jumZRlnzhBoBxGrCOi9QzgjCezTS3Nw%5FX6kJUrpSBm-Hav1w-UkdSlG3ltkRSnqzf6ourQGu%5FUA28CzZCGORvG0LE20YOvo49uqw==&ref=fdaweb.com) (UC) to determine next steps,” it adds.