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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06254950




Registration number
NCT06254950
Ethics application status
Date submitted
2/02/2024
Date registered
12/02/2024

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 Ulcerative Colitis
Scientific title
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2023-506769-67
Secondary ID [2] 0 0
TAK-279-UC-2001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TAK-279
Treatment: Drugs - Placebo

Experimental: TAK-279 Dose 1 - TAK-279, capsules, orally at Dose 1 up to Week 52 as per investigator's discretion.

Experimental: TAK-279 Dose 2 - TAK-279, capsules, orally at Dose 2 for 12 weeks followed by TAK-279 capsules, orally at Dose 1 up to Week 52 as per investigator's discretion.

Placebo comparator: Placebo - TAK-279 matching placebo capsules, orally, for 12 weeks followed by TAK-279 capsules, orally at Dose 1 up to Week 52 as per investigator's discretion.


Treatment: Drugs: TAK-279
TAK-279 capsules.

Treatment: Drugs: Placebo
TAK-279 placebo-matching capsules.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS)
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving Clinical Response at Week 12 Based on Modified Mayo Score (mMS)
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Percentage of Participants Achieving Symptomatic Remission at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving Endoscopic Improvement at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants Achieving Endoscopic Remission at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants With no Bowel Urgency at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of Participants With no Abdominal Pain at Week 12
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score =170 at Week 12
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Change From Baseline in Disease-Specific Health-related Quality of Life (HRQoL) as Measured by IBDQ Total Score at Week 12
Timepoint [8] 0 0
Baseline and Week 12
Secondary outcome [9] 0 0
Change From Baseline in Fatigue as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12
Timepoint [9] 0 0
Baseline and Week 12

Eligibility
Key inclusion criteria
1. Male or female aged 18-75 years old with diagnosis of UC for at least 30 days.
2. Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES.
3. Participants must have had an inadequate response to, loss of response to, or intolerance to at least one conventional, biologic or advance therapy for UC.
4. Participants must meet the contraception recommendations.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants with indeterminate/unclassified inflammatory bowel disease (IBD), microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of Crohn's disease (CD).
2. Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study.
3. Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.
4. Participants who have failed 3 or more classes of advanced therapies.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
4/08/2027
Actual
Sample size
Target
207
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Nepean Clinical School - Kingswood
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Sydney
Recruitment hospital [3] 0 0
Western Health/Footscray Hospital - Melbourne
Recruitment hospital [4] 0 0
Harry Perkins Medical Research Institute Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2139 - Sydney
Recruitment postcode(s) [3] 0 0
3011 - Melbourne
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
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California
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Florida
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Georgia
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Iowa
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Kentucky
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Maryland
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Missouri
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Nevada
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New York
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Oklahoma
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South Carolina
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Texas
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Washington
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Belgium
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Anderlecht / Region Capitale De Bruxelles/ Brussel
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Belgium
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Leuven
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Canada
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Alberta
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British Columbia
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Nova Scotia
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Ontario
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Gangdong
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Guangdong
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China
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Hebei Sheng
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Hubei
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Guangzhou
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Hangzhou
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Zhejiang
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Hradec Kralove
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Ostrava-Poruba
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Praha 5
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Syddanmark
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Aalborg
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Esbjerg
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Hvidovre
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Ulm
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Rome
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Rozzano
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Torino
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Chiba
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Tychy
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Romania
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Jud Timis
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Bucharest
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Bucuresti
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Nove Zamky
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Spain
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Fuenlabrada
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Spain
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Huelva
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Spain
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Madrid
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Basel
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Taiwan
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Zhongzheng District
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Taiwan
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United Kingdom
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E1 2at
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Greater London
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Belfast
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Cambridge
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Takeda Contact
Address 0 0
Country 0 0
Phone 0 0
+1-877-825-3327
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
When will data be available (start and end dates)?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


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/NCT06254950