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

Conditions

• Crohn's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• TAK-279 — DRUG
  TAK-279 capsules.
• Placebo — DRUG
  TAK-279 placebo-matching capsules.

Study Details

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 medical 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.

Key Dates

Start date

Mar 5, 2024

Status verified

May 2026

Primary completion

Sep 18, 2026

Completion

Jul 23, 2027

Study Design

Enrollment

268 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: TAK-279 Dose 1
  Participants will be randomized to receive TAK-279 Dose 1 capsules with TAK-279 placebo-matching capsule orally.
• Experimental: TAK-279 Dose 2
  Participants will be randomized to receive TAK-279 Dose 2 capsules with TAK-279 placebo-matching capsule orally.
• Experimental: TAK-279 Dose 3
  Participants will be randomized to receive TAK-279 Dose 3 capsules orally.
• Experimental: Placebo
  Participants will be randomized to receive TAK-279 placebo-matching capsules orally.

Primary Outcome Measure

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

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (29)

Find similar trials in Los Angeles, CA

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