Recruiting

Testing a New Treatment for Moderately to Severely Active Crohn's Disease

Plain-English translation of NCT07196722 on ClinicalTrials.gov ↗ · Source last updated September 2026 · Translation generated August 2026 · How we translate trials

Read our Crohn Disease research guide →

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 trial is testing a new medication called to see if it can help people with moderate to severe Crohn's disease—a condition that causes painful inflammation of the digestive tract. Researchers want to understand whether this medication works better than placebo (an inactive pill) and whether it is safe to use. About 1,092 people will participate in this study, which is being run by Janssen Research & Development.

Many people with Crohn's disease do not respond well enough to current treatments, or they cannot tolerate the side effects. This medication is being tested to offer a new option for patients who need better control of their symptoms.

Do you qualify?

You likely qualify if…

you have been diagnosed with Crohn's disease for at least 12 weeks, confirmed by both colonoscopy and a biopsy report
you have moderate to severe active Crohn's disease based on your current symptoms and recent endoscopy findings
you have either not responded well to standard treatments or could not tolerate them, or you have failed to respond adequately to advanced biologic or oral medications
if you are a woman of childbearing age, you have a negative pregnancy test and agree to use contraception and take additional pregnancy tests during the study
you are willing to receive either the new medication or a placebo for up to 12 weeks and possibly longer depending on how you respond

You likely don't qualify if…

you have complications of Crohn's disease such as strictures (narrowing of the bowel) or fistulas that may require surgery during the study
you currently have a stoma or ostomy (surgically created opening)
you have had colon surgery within the past 24 weeks or other major surgery within the past 12 weeks
you have polyps in your colon outside of areas of known inflammation that have not been removed
you are currently pregnant or breastfeeding

What participation looks like

If you join this study, you will be randomly assigned to receive either the new medication at one of two doses or a placebo for the first 12 weeks. During this initial phase, you will have regular clinic visits to check how well the treatment is working and to monitor for any side effects. After 12 weeks, your treatment plan may change based on how your disease responds. You will undergo colonoscopies and blood tests at certain timepoints, and you will be asked to track your symptoms and bowel movements. The study involves two separate "induction" phases to thoroughly test the medication's effectiveness and safety.

AI-generated summary from trial data · Aug 10, 2026 · Not medical advice

Trial locations(372 sites)

United States

AZ Gastro Care, Chandler, Arizona

Research Solutions of Arizona, Litchfield Park, Arizona

Mayo Clinic, Scottsdale, Arizona

Clinnova Research, Anaheim, California

Alliance Research Institute, LLC - Canoga Park, Canoga Park, California