A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery
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ClinicalTrials.gov Identifier: NCT03943446 |
Recruitment Status :
Terminated
(Sponsor decision to discontinue study due to inability to recruit the expected number of subjects within the requisite time period.)
First Posted : May 9, 2019
Results First Posted : September 7, 2023
Last Update Posted : September 7, 2023
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Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | May 7, 2019 | ||||||||||||||||
First Posted Date ICMJE | May 9, 2019 | ||||||||||||||||
Results First Submitted Date ICMJE | August 11, 2023 | ||||||||||||||||
Results First Posted Date ICMJE | September 7, 2023 | ||||||||||||||||
Last Update Posted Date | September 7, 2023 | ||||||||||||||||
Actual Study Start Date ICMJE | August 4, 2020 | ||||||||||||||||
Actual Primary Completion Date | August 25, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
Percentage of Participants With Endoscopic Recurrence of CD as Assessed by Rutgeerts Grading Scale at Week 26 [ Time Frame: At Week 26 ] Endoscopic recurrence (ER) is defined as a Rutgeerts' score ≥ i2. The Rutgeerts scoring is a 5-point scale used to assess endoscopic recurrence at the ileocolonic anastomosis and preanastomotic ileum. The total score ranges from i0 to i4; where i0 = no lesions, i1= ≤ 5 aphthous ulcers, i2= > 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. Higher score indicates worsening. Percentages are rounded off to the nearest single decimal.
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Original Primary Outcome Measures ICMJE |
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 ] An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
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Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery | ||||||||||||||||
Official Title ICMJE | 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 | ||||||||||||||||
Brief Summary | The main aim is to see if TAK-018 reduces the recurrence of intestinal inflammation after abdominal resection surgery in adults with Crohn's disease. Participants will take either TAK-018 or placebo tablets by mouth, 2 times each day for up to 26 weeks after surgery. The placebo looks like TAK-018 but will not have any medicine in it. Participants will have 6 study visits while receiving treatment. Visits 1 and 6 will be conducted at the study clinic. The others can be in the clinic or at the participant's home. Follow-up will occur 4 weeks after final treatment. |
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Detailed Description | The drug being tested in this study is called TAK-018 (Sibofimloc). 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):
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. Assessments after surgery and endoscopy at Week 26 will be conducted at the clinic. All other study visits may be conducted by telehealth and home health care (HHC). 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. |
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Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Crohn Disease | ||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Terminated | ||||||||||||||||
Actual Enrollment ICMJE |
34 | ||||||||||||||||
Original Estimated Enrollment ICMJE |
75 | ||||||||||||||||
Actual Study Completion Date ICMJE | August 25, 2022 | ||||||||||||||||
Actual Primary Completion Date | August 25, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | Austria, France, Germany, United Kingdom, United States | ||||||||||||||||
Removed Location Countries | Netherlands | ||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT03943446 | ||||||||||||||||
Other Study ID Numbers ICMJE | TAK-018-2001 2019-000886-19 ( EudraCT Number ) U1111-1225-5064 ( Registry Identifier: WHO ) NR266345 ( Registry Identifier: IRAS ) NL71098.018.19 ( Registry Identifier: CCMO ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Takeda | ||||||||||||||||
Original Responsible Party | Millennium Pharmaceuticals, Inc. | ||||||||||||||||
Current Study Sponsor ICMJE | Takeda | ||||||||||||||||
Original Study Sponsor ICMJE | Millennium Pharmaceuticals, Inc. | ||||||||||||||||
Collaborators ICMJE | Takeda Development Center Americas, Inc. | ||||||||||||||||
Investigators ICMJE |
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PRS Account | Takeda | ||||||||||||||||
Verification Date | August 2023 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |