Recruiting

Long-term Safety Study of a New Bowel Inflammation Treatment

Plain-English translation of NCT06764615 on ClinicalTrials.gov ↗ · Source last updated May 2026 · Translation generated June 2026 · How we translate trials

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Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This is a continuation study for people who have already participated in earlier trials of an experimental medication called (TAK-279) and benefited from it. The goal is to see how safe and effective the medication remains when people take it for up to three years, and whether it continues to reduce bowel inflammation and symptoms in adults with moderate to severe ulcerative colitis or Crohn's disease.

Ulcerative colitis and Crohn's disease are serious long-term conditions that cause painful inflammation in the gut and can significantly affect quality of life. This trial exists to understand whether this new medication can safely control these conditions over the long term, giving doctors and patients more treatment options.

Do you qualify?

You likely qualify if…

you have been diagnosed with moderately to severely active ulcerative colitis or Crohn's disease
you completed and responded well to the earlier trial of this medication (either at week 12 or week 52, depending on which earlier study you were in)
you are willing and able to follow all study procedures, including clinic visits and using digital tools to track your symptoms
you are able to give informed written consent and understand the study requirements
you meet the study's contraception recommendations

You likely don't qualify if…

you have been diagnosed with cancer or precancerous changes in your digestive tract during or before the study
you have poor compliance or concerns about being able to take the medication as prescribed, in the investigator's judgment
you are taking oral corticosteroids for your condition at or after week 48 of the earlier trial
your laboratory test results meet certain exclusion criteria outlined in the full study protocol

What participation looks like

If you qualify, you will take the medication by mouth every day for up to three years (156 weeks). You'll visit the study clinic approximately 15 times during this period for check-ups, blood tests, and to discuss how you're feeling. Researchers will track whether your bowel inflammation improves, monitor any side effects, and keep detailed records of your symptoms using digital tools and diary entries.

AI-generated summary from trial data · Jun 11, 2026 · Not medical advice

Long-term Safety Study of a New Bowel Inflammation Treatment

What is this trial?

Do you qualify?

What participation looks like

Trial locations(16 sites)