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

JRCT ID: jRCT2051240050

Registered date:03/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Crohn's Disease
• Date of first enrollment: 05/03/2024
• Target sample size: 268
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

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.

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.

TAK-279 Dose 3
Participants will be randomized to receive TAK-279 Dose 3 capsules orally as per investigator's discretion.

Placebo
Participants will be randomized to receive TAK-279 placebo-matching capsules orally as per investigator's discretion.

Outcome(s)

Primary Outcome

1.Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
Time Frame: 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 Outcome

1.Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12
Time Frame: Week 12
Clinical remission is defined as a CDAI score of <150 points.

2.Percentage of Participants With a Clinical Response Based on the CDAI at Week 12
Time Frame: Week 12
Clinical response is defined as >=100-point decrease from Baseline in CDAI score.

3.Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12
Time Frame: Week 12
Endoscopic remission as per SES-CD is defined as SES-CD score =<4 or =<2 for ileal disease, no subscore >1.

4.Percentage of Participants Achieving Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) at Week 12
Time Frame: 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.

5.Percentage of Participants With a Clinical Response in PRO2 at Week 12
Time Frame: 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.

6.Percentage of Participants With no Bowel Urgency at Week 12
Time Frame: 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.

7.Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score >=170 at Week 12
Time Frame: 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.

8.Change from Baseline in Health-related Quality of Life (HRQoL) as per IBDQ Total Score at Week 12
Time Frame: 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.

9.Change from Baseline in Fatigue as per Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 12
Time Frame: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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 Simplified Endoscopic Score for CD (SES-CD) and CD Activity Index (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.

Exclude 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.

Related Information

• Primary Sponsor: Shikamura Mitsuhiro
• Secondary ID(s): NCT06233461