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A Phase 2b, Multicenter, Randomized, Double-Blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Crohn's Disease

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

Shikamura Mitsuhiro

Takeda Pharmaceutical Company Limited

1-1, Doshomachi 4-chome, Chuo-ku, Osaka

smb.Japanclinicalstudydisclosure@takeda.com

Contact for Clinical Trial Information

Takeda Pharmaceutical Company Limited

1-1, Doshomachi 4-chome, Chuo-ku, Osaka

+81-6-6204-2111

smb.Japanclinicalstudydisclosure@takeda.com

Recruiting

Mar. 05, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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 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 or more conventional, biologic, or advanced therapy for CD.

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.

Both

Crohn's Disease

TAK-279 Dose 1
Participants will be randomized to receive TAK-279 Dose 1 capsules with TAK-279 placebo-matching capsule orally.

TAK-279 Dose 2
Participants will be randomized to receive TAK-279 Dose 2 capsules with TAK-279 placebo-matching capsule orally.

TAK-279 Dose 3
Participants will be randomized to receive TAK-279 Dose 3 capsules orally.

Placebo
Participants will be randomized to receive TAK-279 placebo-matching capsules orally.

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).

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.

+81-72-804-2808

April. 16, 2024

Yes

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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