Crohn's Disease
Conditions
Keywords
Drug Therapy, Latitude CD, Latitude Research Program
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 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.
Detailed description
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.
Interventions
DRUGTAK-279
TAK-279 capsules.
DRUGPlacebo
TAK-279 placebo-matching capsules.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female aged 18-75 years old with diagnosis of CD for at least 30 days. In South Korea, the age requirement for adult participants is \>=19 years of age. 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 or more conventional, biologic, or advanced therapy for CD.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12 | Week 12 | Clinical remission is defined as a CDAI score of \<150 points. |
| Percentage of Participants With a Clinical Response Based on the CDAI at Week 12 | Week 12 | Clinical response is defined as \>=100-point decrease from Baseline in CDAI score. |
| Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12. | Week 12 | Endoscopic remission as per SES-CD is defined as SES-CD score \<=4 or \<=2 for ileal disease, no subscore \>1. |
| Percentage of Participants Achieving Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) at Week 12 | 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. |
| Percentage of Participants With a Clinical Response in PRO2 at Week 12 | 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. |
| Percentage of Participants With no Bowel Urgency at Week 12 | 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. |
| Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score >=170 at Week 12 | 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. |
| Change from Baseline in Health-related Quality of Life (HRQoL) as per IBDQ Total Score at Week 12 | Baseline to 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. |
| Change from Baseline in Fatigue as per Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 12 | Baseline to 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. |
Countries
Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Norway, Poland, Romania, Slovakia, South Korea, Switzerland, Taiwan, United Kingdom, United States
Contacts
CONTACTTakeda Contact
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed