A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for
the Prevention of Postoperative Crohn’s Disease Recurrence.

Purpose of this study?

To assess the safety and tolerability of TAK-018 in postoperative subjects with CD after laparoscopic ileocecal resection with primary anastomosis.

Inclusion Criteria:

• Crohn’s Disease patients planned to undergo a laparoscopic ileocecal resection with primary anastomosis within 72 hours before randomization Day 1.
• Postoperative discontinuation of all concomitant medications specifically related to the treatment of CD
• Has resumed oral intake and is capable of swallowing tablets within 72 hours after surgery.

Exclusion Criteria:

• Has active perianal CD.
• Has had >3 previous surgical procedures for CD.
• Has macroscopically active CD that was not resected at the time of surgery as documented in the surgeon's operative report.
• With small bowel resection that exceeds 100 centimeter (cm) or a participant who is considered at risk of short bowel syndrome by the surgeon or investigator.
• Has active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following: history of tuberculosis, OR positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR a tuberculin skin test reaction ≥10 millimeter (mm) (≥5 mm in participants receiving the equivalent of >15 milligram per day (mg/day) prednisone).
• Has chronic hepatitis B (hepatitis B surface antigen positive, or positive for both hepatitis B surface antibody and hepatitis B core antibody but negative for hepatitis B surface antigen) or hepatitis C infection (evident by viral replication by polymerase chain reaction) within 30 days of randomization.

Primary outcome measures:

Percentage of Participants With Endoscopic Recurrence of CD as Assessed by Rutgeerts Grading Scale at Week 26 [ Time Frame: Week 26 ]

Secondary outcome measures:

Percentage of Participants who Experience Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose of study drug up to Week 30 ]

Study Locations in Europe:

Austria, France, Germany, UK

Estimated Study Completion Date: January 28, 2023

Further information on clinicaltrial.gov with trial number NCT03943446

VV-MEDMAT-69172