Clinical Trials for Crohn's Disease

Crohn's disease is a chronic inflammatory bowel disease (IBD) that can affect any part of the digestive tract, causing abdominal pain, diarrhea, fatigue, and complications that affect daily life. Managing Crohn's often requires specialty medications -- biologics and small molecules that modulate the immune system -- and clinical trials are actively developing new options for people who have not found adequate relief.

If your medication was denied by insurance, or if your current therapy has stopped working, a clinical trial may offer another avenue for treatment.

According to the Crohn's and Colitis Foundation, more than 780,000 Americans live with Crohn's disease, and research into new treatments is robust.

What Types of Trials Are Available?

Biologic trials study new anti-TNF agents, IL-12/23 inhibitors (like ustekinumab/Stelara), and IL-23 inhibitors that represent the next generation beyond current biologics. Integrin inhibitor trials build on the mechanism behind vedolizumab (Entyvio), studying newer gut-selective approaches. Small molecule trials study oral options like S1P receptor modulators and TYK2 inhibitors that work differently from injectable biologics. Combination and sequencing trials study how to use existing and new therapies together to achieve and maintain remission.

Search ClinicalTrials.gov for currently recruiting trials.

Am I Eligible?

Eligibility for Crohn's trials typically considers:

- Confirmed Crohn's diagnosis (often requiring endoscopy and histology)

- Disease location (ileal, colonic, ileocolonic) and severity (mild, moderate, severe)

- Prior treatment history -- biologics tried, response achieved, and reason for discontinuation

- Active disease at the time of enrollment (most trials require evidence of active inflammation)

- No current serious infections or certain other complicating conditions

Many trials specifically enroll people with moderate to severe Crohn's who have not responded to or cannot tolerate conventional therapy or prior biologics.

Your gastroenterologist is the key partner in evaluating your eligibility. Talk to your doctor before making any decisions about your treatment.

What If My Insurance Denied My Medication?

Insurance denials for Crohn's biologics are unfortunately common. Whether your insurer denied Stelara (ustekinumab), Entyvio (vedolizumab), Humira (adalimumab), or another specialty drug, you have the right to appeal -- and that appeal can be strengthened significantly when your gastroenterologist documents your specific clinical need.

While your appeal is in progress, clinical trials studying similar or newer mechanisms may offer access to treatment. This is not a lesser path -- it is a legitimate one.

Ellen can help you figure out your next step. Start with Ellen →

Frequently Asked Questions

Are clinical trials for Crohn's disease free?

In most cases, yes. Trial sponsors (pharmaceutical companies, universities, or the NIH) cover the cost of the experimental treatment. You may still have costs for routine care — like doctor visits or standard tests — depending on your insurance. Always ask the trial coordinator what costs you might be responsible for before enrolling.

How do I find Crohn's disease trials near me?

The best place to start is ClinicalTrials.gov, the official registry of all trials in the US. Search by condition name and filter by your location. Your specialist can also help identify trials at academic medical centers in your region.

Can I join a trial after being denied Remicade or Entyvio?

Yes, and in many cases a denial can actually make you a stronger candidate — trials often enroll patients who have not responded to or cannot access standard treatments. Talk to your doctor about whether your denial history makes you eligible for open trials studying Remicade or Entyvio or similar medications.