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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
NCT06233461 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 268 participants |
| Start Date | 2024-03-05 |
| Est. Completion | 2027-07-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06233461
The ClinicalTrials.gov registry entry for NCT06233461 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 268 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06233461 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06233461?
The interventions under investigation include: Placebo (DRUG), TAK-279 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06233461?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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