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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 Crohn's Disease
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 medical 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.
Study details:
The drug being tested in this study is TAK-279. TAK-279 is being tested to treat participants with moderately to severely active Crohn's disease. The study will look at the efficacy and safety of TAK-279.
The study will enroll approximately 268 participants. During the Induction Period participants will be randomly assigned to one of the following treatment groups in a ratio of 1:1:1:1 to receive TAK-279 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):. 1.
TAK-279 Dose 1. 2. TAK-279 Dose 2.
3. TAK-279 Dose 3. 4.
Placebo. This multi-center trial will be conducted globally. The overall study duration is approximately 60 weeks including 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: 2024-03-05
Primary completion: 2026-09-18
Study completion finish: 2027-07-23
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06233461
Intervention or treatment
DRUG: TAK-279
DRUG: Placebo
Conditions
- • Crohn's Disease
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
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Western Health/Footscray Hospital
Melbourne, Victoria, 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
|
EXPERIMENTAL: TAK-279 Dose 3
| DRUG: TAK-279
|
EXPERIMENTAL: Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 | 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). | Week 12 |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12 | Clinical remission is defined as a CDAI score of \<150 points. | Week 12 |
| Percentage of Participants With a Clinical Response Based on the CDAI at Week 12 | Clinical response is defined as \>=100-point decrease from Baseline in CDAI score. | Week 12 |
| Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12. | Endoscopic remission as per SES-CD is defined as SES-CD score \<=4 or \<=2 for ileal disease, no subscore \>1. | Week 12 |
| Percentage of Participants Achieving Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) at Week 12 | 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. | Week 12 |
| Percentage of Participants With a Clinical Response in PRO2 at Week 12 | 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. | Week 12 |
| Percentage of Participants With no Bowel Urgency at Week 12 | 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. | 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, 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. | Week 12 |
| Change from Baseline in Health-related Quality of Life (HRQoL) as per IBDQ Total Score at Week 12 | 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. | Baseline to Week 12 |
| Change from Baseline in Fatigue as per Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 12 | 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. | Baseline to Week 12 |
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