Recruiting

Testing a new antibody treatment for moderate to severe Crohn's disease

Plain-English translation of NCT06430801 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated July 2026 · How we translate trials

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Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This study is testing a new medication called tulisokibart to see if it can help people with moderate to severe Crohn's disease—especially those whose symptoms haven't improved with other treatments. Tulisokibart is an antibody designed to reduce the inflammation in the digestive system that causes Crohn's symptoms. Researchers will compare the medication at different doses against a placebo (a dummy treatment) to find the safest and most effective approach.

Many people with Crohn's disease don't respond well enough to current treatments or stop responding over time. This trial is exploring whether this new medication can offer hope to patients who have exhausted other options and are still suffering from active inflammation and symptoms.

Do you qualify?

You likely qualify if…

you have had a confirmed Crohn's disease diagnosis for at least 3 months
your Crohn's disease is currently moderate to severe despite treatment
you have not responded well to, lost response to, or could not tolerate standard treatments like steroids, immunomodulators, or biologic drugs
you are at least 16 years old (adolescents may participate in some countries with regulatory approval)
your Crohn's disease involves your colon and/or small intestine (not isolated to just the stomach or upper digestive tract)

You likely don't qualify if…

you have been diagnosed with ulcerative colitis or indeterminate colitis instead of Crohn's disease
you currently have serious complications like an abscess, a blockage in your colon, or severe inflammation requiring urgent surgery
you have had bowel surgery within the past 3 months or have a stoma or colostomy
you have an active or untreated infection, including hepatitis B or C, HIV, tuberculosis, or COVID-19
you have a history of cancer (except fully treated skin cancer) unless you have been disease-free for at least 5 years

What participation looks like

Participants will receive either the new medication or a placebo through an IV infusion first, then switch to regular injections under the skin over several weeks or months. Some participants will continue in an extension phase if their symptoms improve or if certain conditions are met. You'll have multiple visits to the clinic for treatments, blood tests, and symptom assessments to monitor how well the medication works and whether there are any side effects.

Testing a new antibody treatment for moderate to severe Crohn's disease

What is this trial?

Do you qualify?

What participation looks like

Trial locations(499 sites)