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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
The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. 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. The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks).
Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks). During the study, participants will visit their study clinic several times.
Study details:
Study TAK-279-UC-2001 is a multicenter, randomized, placebo-controlled, study with a 12-week double-blinded induction treatment period, a 40-week open-label treatment period (52 total weeks of treatment), and a 4-week safety follow-up period. An approximate total of eligible 207 participants will be randomized to one of the three treatment groups -. 1.
TAK-279 Dose 1. 2. TAK-279 Dose 2.
3. Placebo. The maximum study duration per participant is approximately 60 weeks, including up to 30 days for the screening period, a 12-week randomized and double-blinded induction treatment period, a 40-week open-label treatment period, and a 4-week safety follow-up period.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-03-29
Primary completion: 2026-09-30
Study completion finish: 2027-08-04
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06254950
Intervention or treatment
DRUG: TAK-279
DRUG: Placebo
Conditions
- • Ulcerative Colitis
Find a site
Closest Location:
Nepean Clinical School
Research sites nearby
Select from list below to view details:
Nepean Clinical School
Kingswood, New South Wales, Australia
Concord Repatriation General Hospital
Sydney, New South Wales, Australia
Western Health/Footscray Hospital
Melbourne, Victoria, Australia
Harry Perkins Medical Research Institute Fiona Stanley Hospital
Murdoch, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: TAK-279 Dose 1
| DRUG: TAK-279
|
EXPERIMENTAL: TAK-279 Dose 2
| DRUG: TAK-279
|
PLACEBO_COMPARATOR: Placebo
| DRUG: TAK-279
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Percentage of Participants Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS) | The mMS is a composite score of 3 assessments consisting of stool frequency (SF), rectal bleeding (RB), and endoscopic score (ES). Each component subscore ranges from 0 to 3 and total score range of the mMS is from 0 to 9, with higher scores indicating more severe disease. Clinical remission is defined an mMS of ≤2 with SF subscore ≤ 1, RB subscore = 0, and ES ≤ 1 (score of 1 modified to exclude friability). | Week 12 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Percentage of Participants Achieving Clinical Response at Week 12 Based on Modified Mayo Score (mMS) | Clinical response defined as reduction from baseline in mMS of ≥2 points and ≥30% from baseline and a decrease from baseline in the RB subscore of ≥1 point or an absolute RB subscore of ≤1 point at Week 12. | Baseline, Week 12 |
Percentage of Participants Achieving Symptomatic Remission at Week 12 | Symptomatic remission is defined as a RB subscore of 0 and SF subscore of ≤1. | Week 12 |
Percentage of Participants Achieving Endoscopic Improvement at Week 12 | Endoscopic improvement defined as a modified Mayo ES of ≤1 (score of 1 modified to exclude friability). | Week 12 |
Percentage of Participants Achieving Endoscopic Remission at Week 12 | Endoscopic remission defined as a modified Mayo ES of 0. | Week 12 |
Percentage of Participants With no Bowel Urgency at Week 12 | Bowel urgency measured by the bowel urgency electronic diary (eDiary) item at Week 12. | Week 12 |
Percentage of Participants With no Abdominal Pain at Week 12 | Abdominal pain measured by abdominal pain eDiary item at Week 12. | Week 12 |
Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score ≥170 at Week 12 | The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function (10 items), emotional status (12 items), systemic symptoms (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life. | Week 12 |
Change From Baseline in Disease-Specific Health-related Quality of Life (HRQoL) as Measured by IBDQ Total Score at Week 12 | The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function (10 items), emotional status (12 items), systemic symptoms (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life. | Baseline and Week 12 |
Change From Baseline in Fatigue as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12 | The FACIT-Fatigue is a reliable and valid instrument for measuring fatigue. 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. | Baseline and Week 12 |
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