RecruitingPhase 2interventionalRules rewrite

Phase 2: testing TAK-279 for Crohn's Disease

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. this study wants to measure the how well it works and safety of TAK-279 versus dummy treatment (placebo) in participants with moderately to severely active Crohn's disease (CD).

Official registry: https://clinicaltrials.gov/study/NCT06233461 · Takeda · enrollment listed as 268

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are TAK-279, or Placebo. The registry lists allocation as randomized. Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut.

They plan to enroll about 268 people at 201 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 2b, Multicenter, Randomized, Double-Blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Crohn's Disease

Interventions: TAK-279, Placebo

Primary outcome (registry wording): Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
Male or female aged 18-75 years old with diagnosis of CD for at least 30 days. In South Korea, the age requirement for adult participants is \>=19 years of age
Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI
Participants must have had an inadequate response to, loss of response to, or intolerance to at least one or more conventional, biologic, or advanced therapy for CD

Who the registry excludes

Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis
Have complications of CD that might require surgery during the study
Participants with a current ostomy
Participants who have failed 3 or more classes of advanced therapies

Public study contact (from the registry)

Takeda Contact

+1-877-825-3327

medinfoUS@takeda.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

201 listed

United Medical Doctors — Murrieta, California (recruiting)
UCI Health — Orange, California (recruiting)
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida — Clearwater, Florida (recruiting)
Auzmer Research — Lakeland, Florida (recruiting)
Wellness Clinical Research — Miami Lakes, Florida (recruiting)
GI PROS, Inc. — Naples, Florida (recruiting)
AdventHealth (Florida Hospital) Medical Group — Orlando, Florida (not_yet_recruiting)
USF Health Morsani Center for Advanced Healthcare — Tampa, Florida (recruiting)
Emory University Hospital, The Emory Clinic — Atlanta, Georgia (recruiting)
Atlanta Center For Gastroenterology, P.C. — Decatur, Georgia (recruiting)
The University of Iowa Hospitals & Clinics — Iowa City, Iowa (recruiting)
University of Kansas Medical Center — Kansas City, Kansas (recruiting)

+ 171 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06233461 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06233461?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06233461?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary