Ulcerative Colitis
Conditions
Keywords
Drug Therapy, Latitude UC, Latitude Research Program
Brief summary
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.
Detailed description
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.
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
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 UC 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 UC assessed by mMS and ES. 3. Participants with a history of inadequate response to, loss of response to, or intolerance to one or more of conventional, biologic or advance therapies for UC. 4. Participants must meet the contraception recommendations.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS) | Week 12 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Clinical Response at Week 12 Based on Modified Mayo Score (mMS) | Baseline, Week 12 | 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. |
| Percentage of Participants Achieving Symptomatic Remission at Week 12 | Week 12 | Symptomatic remission is defined as a RB subscore of 0 and SF subscore of ≤1. |
| Percentage of Participants Achieving Endoscopic Improvement at Week 12 | Week 12 | Endoscopic improvement defined as a modified Mayo ES of ≤1 (score of 1 modified to exclude friability). |
| Percentage of Participants Achieving Endoscopic Remission at Week 12 | Week 12 | Endoscopic remission defined as a modified Mayo ES of 0. |
| Percentage of Participants With no Bowel Urgency at Week 12 | Week 12 | Bowel urgency measured by the bowel urgency electronic diary (eDiary) item at Week 12. |
| Percentage of Participants With no Abdominal Pain at Week 12 | Week 12 | Abdominal pain measured by abdominal pain eDiary item at Week 12. |
| 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 (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. |
| Change From Baseline in Disease-Specific Health-related Quality of Life (HRQoL) as Measured by IBDQ Total Score at Week 12 | Baseline and 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. |
| Change From Baseline in Fatigue as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12 | Baseline and 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. |
Countries
Australia, Belgium, Bulgaria, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Norway, Poland, Romania, Slovakia, South Korea, Taiwan, United Kingdom, United States
Contacts
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed