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

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What is this study about?

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.

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 randomization

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

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country	Status
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland

Other Sites

Site Name	City	Country
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Prqmkpefl Ijbdhxzp Mcpmljmk Mradtbkgcfpx Salvw Wsrwppcggmyz I Amkwrsnwakjcn	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	02.01.2024

Trial locations

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.

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 ID:

2023-506452-25-00

Protocol code:

COMBO/2022/3

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?