Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study Comparing Ustekinumab, Infliximab, and Combination Therapy for Patients with Moderate to Severe Ulcerative Colitis

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Ulcerative Colitis, a condition that causes inflammation and sores in the colon and rectum. The study will compare the effectiveness and safety of different treatments for patients with moderate to severe forms of this disease. The treatments being tested include Infliximab, Ustekinumab, and a combination of both. Infliximab is administered as a powder that is mixed into a solution and given through an intravenous infusion, which means it is delivered directly into a vein. Ustekinumab can be given either as a solution for infusion or as an injection using a pre-filled syringe.

The purpose of the study is to determine how well these treatments work in helping patients achieve remission, which means reducing or disappearing symptoms of the disease. The study will also look at the safety of these treatments. Participants will receive one of the treatments and will be monitored over a period of time to see how their condition changes. The study will include a phase where the initial response to the treatment is observed, followed by a longer-term observation period to assess the ongoing effects of the treatment.

Throughout the study, researchers will evaluate various outcomes, such as the percentage of patients who achieve clinical and endoscopic remission, which involves both symptom relief and healing of the colon lining as seen through a scope. The study will also assess the quality of life of participants and any side effects they may experience. This information will help determine the best treatment approach for managing moderate to severe Ulcerative Colitis.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of ulcerative colitis and ensuring the condition is moderately to severely active.

    Eligibility is determined by a Mayo scale score between 7 and 12, which evaluates bowel movement frequency, intestinal bleeding, colon mucosa appearance, and overall health assessment.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of three treatment groups: infliximab monotherapy, ustekinumab monotherapy, or a combination therapy of both drugs.

  3. Step 3

    Treatment administration

    For the infliximab group, the medication is administered through an intravenous infusion.

    For the ustekinumab group, the medication is administered through a subcutaneous injection.

    The combination therapy group receives both infliximab intravenously and ustekinumab subcutaneously.

  4. Step 4

    Remission induction phase

    The primary goal during this phase is to achieve clinical and endoscopic remission. This involves regular monitoring and assessment of symptoms and colon health.

  5. Step 5

    Follow-up assessments

    Participants undergo periodic assessments to evaluate clinical response and remission status at various intervals, including at 52 weeks.

    These assessments include clinical evaluations, endoscopic examinations, and laboratory tests to measure remission and improvement.

  6. Step 6

    Quality of life evaluation

    Participants' quality of life is assessed after the remission induction phase and at 52 weeks to determine the impact of the treatment on daily living.

  7. Step 7

    Adverse events monitoring

    Throughout the trial, any adverse events or serious adverse events are recorded and analyzed to ensure participant safety.

Who can join the trial?

11 criteria

  • Provide written consent to participate in the study and for all planned procedures.
  • Patients taking certain medications like 5-ASA derivatives, glucocorticosteroids, or immunosuppressants can join if they have been on a stable dose for 14 days before the study starts.
  • Be between 18 and 65 years old at the time of screening.
  • Women who can become pregnant must agree not to donate eggs during the study and for 6 months after the last dose of the drug.
  • Women who can become pregnant must agree to use effective birth control during the study and for a certain period after the last dose (15 weeks for UST patients or 6 months for IFX patients).
  • Women of childbearing age must have a negative pregnancy test.
  • Have a diagnosis of **ulcerative colitis (UC)** for at least 3 months before the study starts, confirmed by medical records and tests.
  • Have moderate to severe **ulcerative colitis** with a specific score on the Mayo scale, which measures symptoms like bowel movement frequency, bleeding, and overall health.
  • Have not responded well to standard treatments like corticosteroids or certain immunosuppressants, or cannot tolerate these treatments, or have conditions that prevent using these treatments.
  • Have shown failure of standard treatment for severe **ulcerative colitis**, such as not improving with steroids or needing high doses for a long time.
  • Have not achieved remission or have relapsed despite using immunosuppressive therapy for at least 3 months at the right doses.

Who cannot join the trial?

10 criteria

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent infection that requires treatment with antibiotics.
  • Patients who have a history of allergic reactions to the study medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have been diagnosed with cancer in the past five years.
  • Patients who have a history of heart disease or uncontrolled high blood pressure.
  • Patients who have a history of liver or kidney disease.
  • Patients who have a history of tuberculosis or have been exposed to someone with tuberculosis.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Ustekinumab

    is a medication used to treat moderate to severe ulcerative colitis. It works by targeting specific proteins in the immune system to reduce inflammation and help control symptoms of the disease.

  • Infliximab

    is another treatment option for moderate to severe ulcerative colitis. It is a type of medication known as a biologic, which helps to decrease inflammation by blocking a protein in the body that causes inflammation.

  • COMBinatiOn therapy

    refers to the use of both ustekinumab and infliximab together. This dual biological therapy aims to provide a more effective treatment by combining the benefits of both medications to induce remission in patients with ulcerative colitis.

What is already known about the treatment

  • Ustekinumab

    Ustekinumab is administered via injection, typically under the skin. It is currently used in medicine for treating various inflammatory conditions, with ongoing research in ulcerative colitis. The main therapeutic indication is for moderate to severe ulcerative colitis. Ustekinumab works by targeting specific proteins in the immune system to reduce inflammation. It is classified as a monoclonal antibody.

  • Infliximab

    Infliximab is given through an intravenous infusion, usually in a clinical setting. It is well-established in medical literature for treating autoimmune diseases, including ulcerative colitis. The primary use is for moderate to severe ulcerative colitis. Infliximab functions by blocking a protein called tumor necrosis factor-alpha (TNF-alpha), which plays a role in inflammation. It belongs to the class of medications known as TNF inhibitors.

Investigated diseases

Ulcerative colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of flare-ups and remissions. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in genetically susceptible individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506452-25-00Protocol codeCOMBO/2022/3Estimated enrolment172 patientsSponsorMedical University Of Lodz

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.