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

Takeda

Status and phase: Enrolling; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: TAK-279; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06233461

2023-506704-14 (Other Identifier)

TAK-279-CD-2001

Details and patient eligibility

About

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

Full 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.

Enrollment: 268 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 received prior treatment(s) for CD (according to either (a) or (b) below or a combination of both):

   1. Participants must have had an history of inadequate response to, loss of response to, or intolerance to these therapies based on Physician assessment: 6-mercaptopurine or azathioprine, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of CD symptoms).
   2. Have received treatment with ≥1 biologic agents (such as tumor necrosis factor (TNF) antagonists, antibodies to interleukin (IL) -23p19, IL-12/23p40, vedolizumab) or any advanced therapy (such as Janus kinase inhibitor (JAKi) or sphingosine-1-phosphate (S1P) receptor modulators).

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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268 participants in 4 patient groups

TAK-279 Dose 1

Experimental group

Description:

Participants will be randomized to receive TAK-279 Dose 1 capsules with TAK-279 placebo-matching capsule orally as per investigator's discretion.

Treatment:

Drug: Placebo

Drug: TAK-279

TAK-279 Dose 2

Experimental group

Description:

Participants will be randomized to receive TAK-279 Dose 2 capsules with TAK-279 placebo-matching capsule orally as per investigator's discretion.

Treatment:

Drug: Placebo

Drug: TAK-279

TAK-279 Dose 3

Experimental group

Description:

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

Treatment:

Drug: TAK-279

Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo