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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233461
• Other study ID #: TAK-279-CD-2001
• Secondary ID: 2023-506704-14
• Status: Recruiting
• Phase: Phase 2
• Start date: March 5, 2024
• Est. completion date: July 23, 2027

Study information

• Verified date: April 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 any 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.t

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 patients. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: July 23, 2027
• Est. primary completion date: September 18, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion 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 SES-CD and 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.

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• TAK-279
TAK-279 capsules.
• Placebo
TAK-279 placebo-matching capsules.

Locations

Country	Name	City	State
United States	Novel Research, LLC	Bellaire	Texas
United States	West Central Gastroenterology, LLP, d/b/a/ Gastro Florida	Clearwater	Florida
United States	Great Lakes Gastroenterology Research, LLC	Mentor	Ohio
United States	United Medical Doctors	Murrieta	California
United States	GI PROS, Inc.	Naples	Florida
United States	Rochester Clinical Research	New York	New York
United States	DiGiovanna Institute for Medical Education and Research	North Massapequa	New York
United States	Hightower Clinical - SSM Health, Oklahoma University Health Sciences Center (OUHSC)	Oklahoma City	Oklahoma
United States	Southern Star Research Institute, LLC	San Antonio	Texas
United States	Tyler Research Institute, LLC	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   To obtain more information about this study, click this link