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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

TAK-018 for Prevention of the Recurrence of Postoperative Crohn's Disease (CD)

Clinicaltrials.gov identifier NCT03943446

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted September 24, 2020

Study Description

Brief summary:

The purpose of this study is to evaluate the efficacy of TAK-018 in reducing endoscopic recurrence of intestinal inflammation in postoperative participants with CD after a planned laparoscopic ileocecal resection with primary anastomosis.

  • Condition or Disease:Crohn Disease
  • Intervention/Treatment: Drug: TAK-018
    Drug: TAK-018 Placebo
  • Phase: Phase 2
Detailed Description

The drug being tested in this study is called TAK-018. TAK-018 is used for the prevention of postoperative CD recurrence. This study will evaluate the efficacy of TAK-018 in reducing endoscopic recurrence of intestinal inflammation in postoperative participants with CD after planned laparoscopic ileocecal resection with primary anastomosis. The study will enroll approximately 96 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 1:1:1 ratio to one of the three treatment groups-which will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need): - TAK-018 0.30 g Low dose - TAK-018 1.5 g High dose - Placebo All participants will be asked to take the tablets twice daily immediately after a meal (that is, breakfast and dinner) with water, approximately 8 to 12 hours apart. Participants will have flexibility to either to opt for home health care (HHC) solutions at Screening, Week 3, Week 6, Week 12, Week 18 and Week 30 or travel to the clinic for all scheduled visits per protocol as permitted by local regulations. This flexible approach is designed in response to health care delivery challenges presented by the coronavirus disease (COVID-19) pandemic and to provide additional flexibility during the course of the trial. This multi-center trial will be conducted in the United States, United Kingdom, France, Austria and Germany. The overall time to participate in this study is approximately 34 weeks. Participants will make final visit to the clinic or can opt for HHC visit at Week 30 (30 days after the Week 26 endoscopy) for safety follow-up.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 96 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Prevention
  • Official 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
  • Actual Study Start Date: August 2020
  • Estimated Primary Completion Date: May 2022
  • Estimated Study Completion Date: November 2022
Arms and interventions
Arm Intervention/treatment
Experimental: TAK-018 0.30 g Low Dose
TAK-018 3*0.10 gram (g), tablets, orally, twice daily (BID) for up to 26 weeks.
Drug: TAK-018
TAK-018 immediate-release tablets.
Experimental: TAK-018 1.5 g High Dose
TAK-018 3*0.50 g, tablets, orally, BID for up to 26 weeks.
Drug: TAK-018
TAK-018 immediate-release tablets.
Placebo Comparator: Placebo
TAK-018 placebo-matching 3*0 g tablets, orally, BID for up to 26 weeks.
Drug: TAK-018 Placebo
TAK-018 placebo-matching tablets.
Outcome Measures
  • Primary Outcome Measures: 1. Percentage of Participants With Endoscopic Recurrence of CD as Assessed by Rutgeerts Grading Scale at Week 26 [ Time Frame: Week 26 ]
    Endoscopic recurrence is defined as a Rutgeerts' score greater than or equal to (>=) i2. The Rutgeerts scoring is a 5-point scale used to assess endoscopic recurrence at the ileocolonic anastomosis and preanastomotic ileum. The scale ranges from i0 to i4; where i0 equal to (=) no lesions, i1= less than or equal to (<=) 5 aphthous ulcers, i2= greater than (>) 5 aphthous ulcers with normal mucosa between lesions or lesions are confined to the anastomosis, i3= diffuse aphthous ileitis with diffusely inflamed mucosa and i4= diffuse inflammation with larger ulcers, nodules, and/or narrowing.
  • Secondary Outcome Measures: 1. 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 ]
    Stool samples will be collected for analysis of fecal calprotectin, a biomarker of intestinal inflammatory activity.
  • 2. 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 ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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-α) 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 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.

Contacts and Locations
Contacts

Contact: Takeda Study Registration Call Center +1-877-825-3327 medinfoUS@takeda.com

Locations
Show 41 Study Locations
Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

Study Director: Medical Director Takeda

More Information
  • Responsible Party: Millennium Pharmaceuticals, Inc.
  • ClinicalTrials.gov Identifier: NCT03943446 History of Changes
  • Other Study ID Numbers: TAK-018-2001, 2019-000886-19, U1111-1225-5064, NR266345, NL71098.018.19
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: September 24, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Millennium Pharmaceuticals, Inc.: Drug Therapy
  • Additional relevant MeSH terms: Crohn Disease Recurrence