A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 3 April 2023
• Main ID: NCT03943446
• Date of registration: 07/05/2019
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery
• Scientific title: 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
• Date of first enrolment: August 4, 2020
• Target sample size: 34
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03943446
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Austria, France, Germany, Netherlands, United Kingdom, United States

Contacts

• Name: Study Director
• Affiliation: Takeda

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Must have a documented diagnosis of CD confirmed by endoscopic biopsy before resection
or by tissue obtained at resection.

2. Planned to undergo a laparoscopic ileocecal resection with primary anastomosis within
72 hours before randomization Day 1. Confirmation that no active disease has been left
behind after resection will be based on surgeon's documentation in the operative
report.

3. With postoperative discontinuation of all concomitant medications specifically related
to the treatment of CD. This includes anti-tumor necrosis factor-alpha (TNF-a) and
anti-integrin therapy, anti- interleukin (IL) 12/23, thiopurines and other
immunomodulators, steroids, 5-minosalicylates, and prophylactic use of antibiotics for
the prevention of postoperative recurrence such as metronidazole.

4. Has resumed oral intake and is capable of swallowing tablets within 72 hours after
surgery.

Exclusion Criteria:

1. Has active perianal CD.

2. Has had >3 previous surgical procedures for CD.

3. Has macroscopically active CD that was not resected at the time of surgery as
documented in the surgeon's operative report.

4. 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.

5. 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).

6. 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: TAK-018 Placebo

Drug: TAK-018

Primary Outcome(s)

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

Secondary Outcome(s)

Ctrough: Observed Plasma Trough Concentrations of TAK-018 [Time Frame: Week 3 pre-dose and at multiple time points (up to 12 hours) post-dose]

Percentage of Participants With Fecal Calprotectin (FCP) >135 Microgram per Gram (mcg/g) at Weeks 3, 6, 12, 18, 26 and 30 [Time Frame: Weeks 3, 6, 12, 18, 26 and 30]

Secondary ID(s)

NL71098.018.19

2019-000886-19

U1111-1225-5064

TAK-018-2001

NR266345

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Takeda Development Center Americas, Inc.