A Randomized Double-Blind Placebo-Controlled. Multi-center Proof-of-Mechanism Phase 2a Study to Evaluate the Safety Tolerability and efficacy of TAK-018 (EB8018) for the Prevention of Post-Operative Crohn s Disease Recurrence.

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A Randomized Double-Blind Placebo-Controlled. Multi-center Proof-of-Mechanism Phase 2a Study to Evaluate the Safety Tolerability and efficacy of TAK-018 (EB8018) for the Prevention of Post-Operative Crohn s Disease Recurrence.

Brief description of study

The main purpose of this study is to evaluate how safe and tolerable a drug called TAK-018 (or sibofimloc,the “Takeda Study Drug”) is in people with Crohn’s disease (CD) after bowel resection. The study will also look at whether TAK-018 can stop CD from recurring after surgery. TAK-018 is an investigational drug. “Investigational” means that the study drug being tested has not yet been approved by the United States Food and Drug Administration (FDA). TAK-018 is a tablet which is taken orally (by mouth).

Clinical Study Identifier: s19-00438

ClinicalTrials.gov Identifier: NCT03709628

Principal Investigator: Jordan E Axelrad.

Other Investigators: Shannon Chang, Feza Remzi, John Kirat, David P Hudesman, Simon J Hong.

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