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NCT06233461 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Crohn's Disease, sponsored by Takeda.

Recruiting
Registry status
Phase 2
Development phase
268
Enrollment target
20
Study locations

NCT06233461: Recruiting Phase 2 study of Crohn's Disease, sponsored by Takeda.

NCT06233461 is a Phase 2 study of Crohn's Disease that is actively recruiting participants, run by Takeda. The registered enrollment target is 268 participants, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06233461, a Phase 2 study of Crohn's Disease, is actively recruiting participants, sponsored by Takeda.

RECRUITING
Registry status
Phase 2
Development phase
268 participants
Enrollment target
20
Study locations

Study 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 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.

Primary Outcome

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).

Conditions Studied

Crohn's Disease

Interventions

  • DRUG Placebo
  • DRUG TAK-279

Study Locations (20)

Florida

  • West Central Gastroenterology, LLP, d/b/a/ Gastro Florida - Clearwater
  • Auzmer Research - Lakeland
  • Wellness Clinical Research - Miami Lakes
  • GI PROS, Inc. - Naples
  • USF Health Morsani Center for Advanced Healthcare - Tampa

California

  • GastroIntestinal BioSciences - Los Angeles
  • United Medical Doctors - Murrieta
  • UCI Health - Orange

Georgia

  • Emory University Hospital, The Emory Clinic - Atlanta
  • Atlanta Center For Gastroenterology, P.C. - Decatur

New York

  • Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) - New York
  • Rochester Clinical Research - Rochester

Iowa

  • The University of Iowa Hospitals & Clinics - Iowa City

Kentucky

  • University Of Louisville - Louisville

Maryland

  • Woodholme Gastroenterology Associates - Glen Burnie

Missouri

  • BVL Clinical Research - Liberty

Trial Details

FieldValue
Enrollment Target 268 participants
Start Date 2024-03-05
Est. Completion 2027-07-23
Phase Phase 2
Takeda

408 total trials

What NCT06233461 shows while recruiting

NCT06233461 is an interventional study that assigns participants to a tested intervention. The registered 268 participants enrollment target is mid-sized for trials with a published cap, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (89% lower).

The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06233461 names 20 study sites across 12 states, led by Florida, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT06233461 about?

NCT06233461 is a clinical study titled "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 (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...

What is the current status of trial NCT06233461?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 268 participants. The study started on 2024-03-05. Estimated completion is 2027-07-23.

What conditions does trial NCT06233461 study?

This clinical trial studies the following conditions: Crohn's Disease.

What interventions are being tested in trial NCT06233461?

The interventions under investigation include: Placebo (DRUG), TAK-279 (DRUG).

Who is sponsoring clinical trial NCT06233461?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06233461 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Crohn's Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06233461's enrollment target sits among peer trials

268 44th of 105 higher than 61 of 105 other Crohn's Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06233461

Source: ClinicalTrials.gov NCT06233461, the US trial registry maintained by the National Library of Medicine. NCT06233461 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.