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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 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 2,412-participant average among 104 other Crohn's Disease trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 12 states.
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.
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 268 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,412-participant average among 104 other Crohn's Disease trials with a reported enrollment target (89% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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