Testing a new oral medication for moderate to severe inflammatory bowel disease

Plain-English translation of NCT06754891 on ClinicalTrials.gov ↗ · Source last updated May 2026 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing a new oral medication called TQH3906 to see if it can help people with moderate to severe ulcerative colitis or Crohn's disease — especially those whose symptoms haven't improved with other treatments. The study will compare the medication at two different doses against a placebo (a dummy pill with no active drug) to understand how well it works and how safe it is.

Many people with ulcerative colitis or Crohn's disease don't respond well enough to current treatments, and some can't tolerate them. This trial is exploring whether this new treatment could offer another option for patients who need better control of their symptoms.

Do you qualify?

You likely qualify if…

you are between 18 and 75 years old
you have been diagnosed with ulcerative colitis or Crohn's disease for at least 3 months
you have moderate to severe active disease confirmed by endoscopy or biopsy
you have already tried and either failed to improve on or couldn't tolerate at least one standard treatment (like aminosalicylates, corticosteroids, immunosuppressants, or biologics)
you are willing to use effective contraception from screening through 3 months after the last dose of the study medication

You likely don't qualify if…

you are pregnant or breastfeeding
you have severe complications such as bowel obstruction, perforation, severe bleeding, or signs of cancer
you currently have a colostomy, ileostomy, or fistulas that might require surgery during the trial
you have had a large section of your small intestine removed or have short bowel syndrome requiring IV nutrition
you have an active C. difficile infection or certain viral infections (hepatitis or CMV colitis) that haven't been adequately treated

What participation looks like

You would attend a screening visit (up to 4 weeks), then take either the new medication or a placebo by mouth for 12 weeks while attending regular check-in visits. After treatment ends, you would return for a 4-week follow-up period to monitor how you're doing. The study team will track your symptoms, take blood samples, and perform an endoscopy to see how your bowel is healing.

AI-generated summary from trial data · Jun 29, 2026 · Not medical advice

Testing a new oral medication for moderate to severe inflammatory bowel disease

What is this trial?

Do you qualify?

What participation looks like

Trial locations(30 sites)