A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

Takeda

Status and phase: Enrolling; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: TAK-279; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06254950

2023-506769-67 (Registry Identifier)

jRCT2031240228 (Registry Identifier)

TAK-279-UC-2001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 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 UC for at least 30 days.
2. Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES.
3. Participants must have had an inadequate response to, loss of response to, or intolerance to at least one conventional, biologic or advance therapy 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 3 patient groups, including a placebo group

TAK-279 Dose 1

Experimental group

Description:

TAK-279, capsules, orally at Dose 1 up to Week 52 as per investigator's discretion.

Treatment:

Drug: TAK-279

TAK-279 Dose 2

Experimental group

Description:

TAK-279, capsules, orally at Dose 2 for 12 weeks followed by TAK-279 capsules, orally at Dose 1 up to Week 52 as per investigator's discretion.

Treatment:

Drug: TAK-279

Placebo

Placebo Comparator group

Description:

TAK-279 matching placebo capsules, orally, for 12 weeks followed by TAK-279 capsules, orally at Dose 1 up to Week 52 as per investigator's discretion.

Treatment:

Drug: Placebo

Drug: TAK-279