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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06233461
Registration number
NCT06233461
Ethics application status
Date submitted
23/01/2024
Date registered
31/01/2024
Titles & IDs
Public title
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease
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Scientific title
A Phase 2b, Multicenter, Randomized, Double-Blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Crohn's Disease
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Secondary ID [1]
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2023-506704-14
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Secondary ID [2]
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TAK-279-CD-2001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
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0
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
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0
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TAK-279
Treatment: Drugs - Placebo
Experimental: TAK-279 Dose 1 - Participants will be randomized to receive TAK-279 Dose 1 capsules with TAK-279 placebo-matching capsule orally as per investigator's discretion.
Experimental: TAK-279 Dose 2 - Participants will be randomized to receive TAK-279 Dose 2 capsules with TAK-279 placebo-matching capsule orally as per investigator's discretion.
Experimental: TAK-279 Dose 3 - Participants will be randomized to receive TAK-279 Dose 3 capsules orally as per investigator's discretion.
Experimental: Placebo - Participants will be randomized to receive TAK-279 placebo-matching capsules orally as per investigator's discretion.
Treatment: Drugs: TAK-279
TAK-279 capsules.
Treatment: Drugs: Placebo
TAK-279 placebo-matching capsules.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
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Assessment method [1]
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Endoscopic response is defined by decrease in SES-CD \>50% from baseline (or for participants with isolated ileal disease, SES-CD =4 or at least a 2-point reduction from baseline). SES-CD evaluates 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing).
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12
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Assessment method [1]
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Clinical remission is defined as a CDAI score of \<150 points.
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Percentage of Participants With a Clinical Response Based on the CDAI at Week 12
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Assessment method [2]
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Clinical response is defined as =100-point decrease from Baseline in CDAI score.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12.
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Assessment method [3]
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Endoscopic remission as per SES-CD is defined as SES-CD score =4 or =2 for ileal disease, no subscore \>1.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Percentage of Participants Achieving Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) at Week 12
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Assessment method [4]
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Clinical remission based on PRO2 is defined as average daily liquid or very soft stool frequency (SF) score =2.8 and not worse than baseline and average daily abdominal pain (AP) score =1 and not worse than baseline.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Percentage of Participants With a Clinical Response in PRO2 at Week 12
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Assessment method [5]
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Clinical response based on PRO2 is defined as =30% decrease in average daily very soft or liquid stools and/ or =30% decrease in average AP from baseline.
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Percentage of Participants With no Bowel Urgency at Week 12
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Assessment method [6]
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Bowel urgency is assessed using a 1-item daily patient diary that asks participants to indicate if they had an urgent bowel movement (when they felt the need to rush to the toilet to avoid an accident) in the past 24 hours. Response options, "Yes" or "No" will be coded as numeric values.
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score =170 at Week 12
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Assessment method [7]
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The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question will be assessed on a 7-point Likert scale. Each domain score is the sum of 8 responses each ranging from 1 to 7, where 1 indicates worst function and 7 the best. The total score ranges from 32 to 224, with higher scores representing better quality of life.
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Timepoint [7]
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Week 12
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Secondary outcome [8]
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Change from Baseline in Health-related Quality of Life (HRQoL) as per IBDQ Total Score at Week 12
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Assessment method [8]
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The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question will be assessed on a 7-point Likert scale. Each domain score is the sum of 8 responses each ranging from 1 to 7, where 1 indicates worst function and 7 the best. The total score ranges from 32 to 224, with higher scores representing better quality of life.
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Timepoint [8]
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Baseline to Week 12
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Secondary outcome [9]
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Change from Baseline in Fatigue as per Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 12
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Assessment method [9]
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FACIT-Fatigue questionnaire contains 13 fatigue-related questions. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 5-point Likert scale, where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit and 4=Very much. The total score ranges from 0 to 52. High scores represent less fatigue.
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Timepoint [9]
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Baseline to Week 12
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Eligibility
Key inclusion criteria
1. Male or female aged 18-75 years old with diagnosis of CD for at least 30 days.
2. Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.
3. Participants must have received prior treatment(s) for CD (according to either (a) or (b) below or a combination of both):
1. Participants must have had an history of inadequate response to, loss of response to, or intolerance to these therapies based on Physician assessment: 6-mercaptopurine or azathioprine, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of CD symptoms).
2. Have received treatment with =1 biologic agents (such as tumor necrosis factor (TNF) antagonists, antibodies to interleukin (IL) -23p19, IL-12/23p40, vedolizumab) or any advanced therapy (such as Janus kinase inhibitor (JAKi) or sphingosine-1-phosphate (S1P) receptor modulators).
4. Participants must meet the contraception recommendations.
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Minimum age
18
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
2. Have complications of CD that might require surgery during the study.
3. Participants with a current ostomy.
4. Participants who have failed 3 or more classes of advanced therapies.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/03/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
23/07/2027
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Actual
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Sample size
Target
268
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Nepean Clinical School - Kingswood
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Concord Repatriation General Hospital - Sydney
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Royal Adelaide Hospital - Adelaide
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Western Health/Footscray Hospital - Melbourne
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2747 - Kingswood
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2139 - Sydney
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3011 - Melbourne
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Romania
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State/province [110]
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Jud Timis
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Country [111]
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Romania
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State/province [111]
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Bucharest
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Country [112]
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Romania
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State/province [112]
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Bucuresti
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Country [113]
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Slovakia
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Banska Bystrica
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Slovakia
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State/province [114]
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Bratislava
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Slovakia
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State/province [115]
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Kosice
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Slovakia
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State/province [116]
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Nove Zamky
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Spain
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State/province [117]
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Huelva
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Spain
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Las Palmas De Gran Canaria
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Switzerland
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State/province [119]
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Basel
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Country [120]
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Switzerland
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State/province [120]
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Bern
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Taiwan
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Changhua County
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Taiwan
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State/province [122]
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Zhongzheng District
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Taiwan
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Kaohsiung
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Taiwan
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State/province [124]
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Taichung City
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Taiwan
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State/province [125]
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Taoyuan City
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United Kingdom
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State/province [126]
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Cambridgeshire
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United Kingdom
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State/province [127]
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E1 2at
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United Kingdom
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Belfast
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Takeda
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Ethics approval
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Summary
Brief summary
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems. An endoscopy will be used to check the bowel for inflammation. The participants will be treated with TAK-279 for 52 weeks (1 year). During the study, participants will visit their study clinic 15 times.t
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Trial website
https://clinicaltrials.gov/study/NCT06233461
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Study Director
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Takeda
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Contact person for public queries
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Takeda Contact
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+1-877-825-3327
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
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Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06233461