Recruiting

Testing a new medication for moderately to severely active Crohn's disease

Plain-English translation of NCT07577843 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated July 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 moderately to severely active Crohn's disease — a serious intestinal condition that gets worse over time. Researchers will compare this medication to an existing treatment called to determine which works better and is safer for patients. About 460 people will participate in this study over 48 weeks.

Many people with Crohn's disease don't respond well enough to current treatments or develop tolerance to them over time. This trial seeks to find out whether this new medication offers a better option for patients whose disease is not adequately controlled.

Do you qualify?

You likely qualify if…

you have been diagnosed with Crohn's disease for at least 12 weeks before joining, confirmed by endoscopy and biopsy
your Crohn's disease is moderately to severely active, based on symptom scores and intestinal inflammation seen during endoscopy
you have had an inadequate response to, lost response to, or cannot tolerate previously approved systemic treatments for Crohn's disease
you have symptoms including frequent loose stools (4 or more per day on average) or significant abdominal pain

You likely don't qualify if…

you have been diagnosed with ulcerative colitis, indeterminate colitis, or other forms of colitis
you have complications like bowel strictures, stenosis, or other issues that might require surgery during the study
you currently have or are suspected of having a bowel abscess
you have a history of short bowel syndrome or are missing more than 2 of the 5 intestinal segments
you have a functioning stoma or ostomy

What participation looks like

If you join this trial, you'll receive intravenous infusions or injections of either the new medication or the comparison treatment at specific intervals — starting with doses at weeks 0, 4, and 8, then maintenance doses once every 4 weeks. The main study lasts 48 weeks, during which you'll have regular visits to check how well the treatment is working and monitor for any side effects. If your disease doesn't improve enough, you may receive additional rescue doses, and if the treatment helps you, you may be invited to continue in an extended phase after the main study ends.

AI-generated summary from trial data · Jul 7, 2026 · Not medical advice

Trial locations(55 sites)

United States

Clinnova Research, Anaheim, California

Gastro SB Clinic, Chula Vista, California

Medical Associates Research Group, Inc., San Diego, California

Peak Gastroenterology Associates, Colorado Springs, Colorado

Sanchez Clinical Research, Inc, Miami, Florida