Clinical Trials for Ulcerative Colitis

Ulcerative colitis (UC) is a chronic inflammatory bowel disease affecting the lining of the colon and rectum, causing symptoms like urgent diarrhea, blood in the stool, abdominal cramping, and fatigue. For many people, controlling UC requires specialty biologics or small-molecule medications -- and these drugs are frequently subject to insurance prior authorization and denial.

Clinical trials are actively developing new options for UC treatment, including medications that may be more effective, better tolerated, or more accessible than current standards.

The Crohn's and Colitis Foundation estimates that ulcerative colitis affects approximately 907,000 Americans, and it is one of the most actively researched areas in gastroenterology.

What Types of Trials Are Available?

Biologic trials are studying new and next-generation anti-TNF agents, IL-23 inhibitors, and integrin blockers for people who have not achieved remission on current therapies. S1P receptor modulator trials study oral medications that work by preventing immune cells from reaching the gut. This is an emerging class with a different mechanism than injectable biologics. JAK inhibitor trials study tofacitinib and newer oral agents that provide rapid onset of action, which is particularly important during active flares. Mucosal healing trials are studying whether achieving deep remission (including healing of the intestinal lining, not just symptom relief) changes long-term outcomes.

Search ClinicalTrials.gov for currently recruiting UC trials.

Am I Eligible?

Common eligibility factors for UC trials include:

- Confirmed UC diagnosis (typically via colonoscopy and biopsy)

- Active disease with a minimum disease activity score at enrollment

- Prior treatment history with specific biologics or conventional therapy

- No current serious infection, active tuberculosis, or malignancy

- No recent colorectal surgery (some trials exclude people who have had a colectomy)

Many trials enroll people with moderate to severe UC who have not achieved adequate response on mesalamine (5-ASA), corticosteroids, or prior biologics.

Talk to your gastroenterologist to evaluate which trials fit your specific disease profile. Talk to your doctor before making any decisions about your treatment.

What If My Insurance Denied My Medication?

Insurance denials for UC medications are common, particularly for biologics like vedolizumab (Entyvio), ustekinumab (Stelara), infliximab (Remicade), and adalimumab (Humira). If your gastroenterologist prescribed one of these and your insurer said no -- often citing step therapy requirements or formulary restrictions -- you have real options.

You can appeal the denial, and a strong letter of medical necessity from your doctor can significantly improve your chances. At the same time, clinical trials studying similar or newer mechanisms may offer another way to access treatment.

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

Frequently Asked Questions

Are clinical trials for ulcerative colitis 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 ulcerative colitis 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 Entyvio or Stelara?

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 Entyvio or Stelara or similar medications.