Ulcerative colitis treatment has expanded rapidly with biologics and oral small-molecule drugs targeting different inflammation pathways, including JAK inhibitors and S1P modulators. Many patients reach remission, but choosing the right drug — and reaching deep healing of the colon lining — remains a focus of research.
What's actually going on in research
Trials are testing IL-23 inhibitors, JAK inhibitors, S1P modulators, gut-selective biologics, and combination therapy for moderate-to-severe disease. Researchers are also studying surgical alternatives, treatments to prevent colon cancer in long-standing disease, and microbiome-based approaches like fecal transplants.
New oral drugs
JAK inhibitor pills like upadacitinib and S1P modulators like ozanimod are giving patients an alternative to injections. Trials are testing newer drugs in these classes.
IL-23 inhibitors
Injections targeting IL-23 are showing strong response rates in ulcerative colitis, including in patients whose disease has resisted earlier biologics.
Mucosal healing
Treating until the colon lining looks normal — not just until bleeding stops — leads to fewer flares and surgeries. Trials are testing how to reach this goal faster.
What to know before you search
Eligibility often depends on disease severity, extent (proctitis, left-sided, or extensive), prior medications, and response to recent treatment.
What types of trials are currently open
- New medication trials — Testing biologics and oral drugs for ulcerative colitis, including new pill options.
- Surgical trials — Studies of surgical approaches when medications fail, including pouch surgery.
- Therapy strategy trials — Testing combinations and sequences of medications to reach deep remission.
- Microbiome trials — Testing fecal transplants and microbiome-based treatments for ulcerative colitis.
- Observational studies — Following people with ulcerative colitis to understand disease course and cancer risk.
Recently added Ulcerative Colitis trials
Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis(UPRISE)
This clinical trial aims to evaluate the comparative efficacy and safety of upadacitinib versus infliximab as second-line treatments for acute severe ulcerative colitis, addressing the following key questions: (1) Can upadacitinib as a second-line therapy effectively induce remission in acute severe ulcerative colitis with efficacy non-inferior to infliximab? (2) What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis? Researchers will also compare the efficacy of upadacitinib with that of corticosteroids to assess its therapeutic effect. Participants will be assigned to either the upadacitinib group (receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily) or the infliximab group (receiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose). The treatment duration is 3 months, with outpatient visits for examinations and tests every two weeks. Patients will record their bowel movements and symptoms such as abdominal pain, and undergo colonoscopy, ultrasound examinations, and blood tests at specified time points.
Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis(UPFRONT)
The goal of this clinical trial is to learn comparative effectiveness and safety of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis. The main questions it aims to answer are: 1. Whether upadacitinib can effectively induce remission in acute severe ulcerative colitis with an efficacy non-inferior to that of corticosteroids. 2. What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis? Researchers will compare upadacitinib with corticosteroids to evaluate the efficacy of upadacitinib in the treatment of acute severe ulcerative colitis.Participants will: 1. Upadacitinib group: Upadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily. 2. Corticosteroid group: Methylprednisolone for injection 60 mg/day. If clinical response is achieved, switch to oral prednisone acetate tablets after 5 days (calculated at 0.75 mg/kg/day), followed by a weekly prednisone taper of 5 mg. When the dose is reduced to 20 mg, taper by 2.5 mg weekly until discontinued, with mesalazine 4 g/day as maintenance therapy. 3. Take drug Upadacitinib or Corticosteroid every day for 3 months 4. Visit the clinic once every 2 weeks for checkups and tests 5. Record the patient's bowel movements and the presence of symptoms such as abdominal pain, while performing colonoscopy, ultrasound examination, and blood tests at the specified time points.
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