Ulcerative colitis causes inflammation and ulcers in the colon and rectum, affecting about 1 million people in the U.S. Treatment includes anti-inflammatory drugs, immune suppressants, and biologics that target specific immune proteins. Many people achieve remission, but some need surgery to remove part or all of the colon.
What's actually going on in research
Trials are testing new biologics and small-molecule drugs that block different immune pathways, including JAK inhibitors, IL-23 inhibitors, and S1P receptor modulators. Researchers are also studying fecal microbiota transplant to restore gut bacteria balance, drugs that heal the intestinal lining rather than just suppress inflammation, and stem cell approaches for severe disease.
JAK inhibitors and S1P modulators
Pills like tofacitinib and ozanimod work inside immune cells to reduce inflammation. Trials are comparing them to biologics and testing whether they work faster or in people who haven't responded to other drugs.
IL-23 targeting
Drugs that block IL-23, a protein that drives chronic inflammation, have shown promise in Crohn's disease and are now being tested in ulcerative colitis. They may offer longer-lasting remission with less frequent dosing.
Microbiome therapies
Studies are testing whether transplanting stool from healthy donors or giving specific bacterial strains can restore normal gut function. Early trials suggest some patients achieve remission without immune suppression.
What to know before you search
Eligibility typically depends on disease severity, extent of colon involvement, whether you've tried biologics before, and current symptoms like bleeding or stool frequency.
What types of trials are currently open
- Induction trials — Testing whether a new drug can bring active ulcerative colitis into remission within 8 to 12 weeks.
- Maintenance trials — Testing whether a drug keeps people in remission over one to two years after initial response.
- Head-to-head trials — Comparing two approved treatments directly to see which works better or has fewer side effects.
- Microbiome trials — Testing fecal transplant or specific bacteria to see if changing gut microbes can control inflammation.
- Combination trials — Testing whether using two drugs together works better than one alone, especially in moderate to severe disease.
Recently added Ulcerative Colitis trials
Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease
This observational study aims to identify genes that may affect how patients with inflammatory bowel disease respond to anti-TNF treatment and why some patients lose response to treatment over time. The study will examine whether genetic markers can help predict which patients are more likely to respond to anti-TNF therapy. Participants who have not previously received anti-TNF treatment and are about to start advanced therapy will provide a blood sample to test for the genetic markers. Participants will also undergo regular assessments of current treatment, disease activity, and inflammatory markers during follow-up.
A Phase I Study to Evaluate the Safety/Tolerability of BDHK-2009 Tablets in Healthy Adult
A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in healthy adult participants.
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