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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06233461




Registration number
NCT06233461
Ethics application status
Date submitted
23/01/2024
Date registered
31/01/2024
Date last updated
10/06/2024

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
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
Secondary ID [1] 0 0
2023-506704-14
Secondary ID [2] 0 0
TAK-279-CD-2001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants With a Clinical Response Based on the CDAI at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12.
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants Achieving Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants With a Clinical Response in PRO2 at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of Participants With no Bowel Urgency 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 Health-related Quality of Life (HRQoL) as per IBDQ Total Score at Week 12
Timepoint [8] 0 0
Baseline to Week 12
Secondary outcome [9] 0 0
Change from Baseline in Fatigue as per Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 12
Timepoint [9] 0 0
Baseline to Week 12

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 had an inadequate response to, loss of response to, or
intolerance to at least one conventional or biologic therapy for CD.

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 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.

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 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
5/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/07/2027
Actual
Sample size
Target
268
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Nepean Clinical School - Kingswood
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Sydney
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Western Health/Footscray Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2139 - Sydney
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3011 - Melbourne
Recruitment outside Australia
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Newcastle

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

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/ct2/show/NCT06233461
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
medinfoUS@takeda.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06233461