Study on BI 3032950 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 effects of a new treatment for ulcerative colitis, a chronic condition that causes inflammation and sores in the digestive tract, specifically affecting the colon and rectum. The treatment being tested is called BI 3032950, which is administered as a solution for injection or infusion. The purpose of the study is to evaluate how effective, safe, and tolerable this treatment is for patients with moderate to severe forms of the disease.

Participants in the study will receive BI 3032950 initially through an intravenous (IV) method, which means the medication is delivered directly into a vein. After this induction phase, the treatment will continue with subcutaneous (SC) injections, where the medication is injected under the skin. The study will monitor patients over a period of time to see if they achieve clinical remission, which means a significant reduction or disappearance of symptoms, by Week 12. The study will also look at other outcomes, such as improvements seen during an endoscopy, a procedure that uses a camera to view the inside of the colon.

Throughout the study, researchers will keep track of any side effects or adverse events that may occur. The trial is designed to last up to 104 weeks, allowing for a comprehensive assessment of the treatment’s long-term effects. This study aims to provide valuable insights into whether BI 3032950 can be a beneficial treatment option for those suffering from ulcerative colitis.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, medical staff will confirm your eligibility based on specific criteria, such as age and medical history related to ulcerative colitis.

You will receive detailed information about the study, including the treatment plan and any potential risks or benefits. You will have the opportunity to ask questions before providing your consent to participate.

2 induction treatment

The treatment begins with an intravenous (IV) administration of the medication BI 3032950. This phase is known as the induction phase and aims to initiate the treatment process.

The frequency and dosage of the IV administration will be explained to you by the medical staff. This phase is designed to last for a specific period, which will be communicated to you during the initial visit.

3 maintenance treatment

Following the induction phase, you will transition to the maintenance phase, where the medication BI 3032950 will be administered subcutaneously (SC). This means the medication will be injected under the skin.

The frequency and dosage of the SC administration will be provided by the medical staff. This phase is intended to maintain the effects of the initial treatment over a longer period.

4 regular assessments

Throughout the study, you will undergo regular assessments to monitor your health and the effectiveness of the treatment. These assessments may include physical examinations, blood tests, and questionnaires about your symptoms.

The primary goal is to evaluate the treatment’s impact on achieving clinical remission by Week 12, which means a significant reduction in symptoms.

5 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation will be conducted to assess the overall outcomes of the study. This includes measuring changes in your condition and any side effects experienced.

The results will help determine the effectiveness and safety of the medication BI 3032950 for treating moderate to severe ulcerative colitis.

Who Can Join the Study?

Participants must be female or male and aged between 18 to 80 years at the time they agree to join the study.
Participants must have been diagnosed with ulcerative colitis for at least 3 months before the screening. This diagnosis should be confirmed by a doctor through a procedure called an endoscopy (a test where a doctor looks inside the body using a special camera) and a histopathology report (a detailed examination of tissue samples).
Participants should have had an inadequate response (the treatment did not work well enough), loss of response (the treatment stopped working), or intolerance (unable to continue due to side effects) to previous treatments with biologic/targeted therapy (specialized medications for treating ulcerative colitis). They may also have stopped these treatments for any other reason.
Female participants who can have children must be willing and able to use highly effective methods of birth control to prevent pregnancy. Male participants are required to use condoms during the study.
There are additional criteria that participants must meet to join the study.

Who Cannot Join the Study?

Patients with any other significant health conditions that could interfere with the study.
Patients who have had recent surgery related to their condition.
Patients who are currently participating in another clinical trial.
Patients who have a history of severe allergic reactions.
Patients who are pregnant or breastfeeding.
Patients who have a history of substance abuse.
Patients who are unable to comply with the study procedures.
Patients who have been diagnosed with certain infections.
Patients who have received certain medications recently that could affect the study results.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Endomed s.r.o.	Kosice	Slovakia
F D Roosevelt University General Hospital Of Banska Bystrica	Banska Bystrica	Slovakia
Synexus Polska Sp. z o.o.	Poznan	Poland
CHC MontLegia	Liege	Belgium
Gastromed Sp. z o.o.	Torun	Poland
KM Management spol. s r.o.	Nitra	Slovakia
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.	Wloclawek	Poland
Medrise Sp. z o.o.	Lublin	Poland
Centrum Medyczne Medyk Sp. z o.o.	Rzeszow	Poland
Iscare a.s.	Prague	Czechia
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
Endoskopia Sp. z o.o.	Sopot	Poland
Planetmed Sp. z o.o.	Wroclaw	Poland
Gastro LM s.r.o.	Presov	Slovakia
EMC Instytut Medyczny S.A.	Poznan	Poland
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz	Warsaw	Poland
Pbmprxv Mtzseo Ski z Ooea Ezi Pmrdogqqv	Poniatowa	Poland
Ebxukja Pyamwludi Sat z oiov	Pabianice	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	10.12.2024
Czechia	Not recruiting	10.12.2024
Poland	Not recruiting	10.12.2024
Slovakia	Not recruiting	10.12.2024

Trial locations

Investigated Drugs:

Bi 3032950

BI 3032950 is a medication being tested in this clinical trial for its effectiveness in treating moderate to severe ulcerative colitis. Ulcerative colitis is a condition that causes inflammation and sores in the lining of the large intestine. This medication is given to patients first through an intravenous (IV) infusion, which means it is delivered directly into the bloodstream through a vein. After the initial treatment, patients continue to receive the medication through subcutaneous injections, which means it is injected under the skin. The goal of this treatment is to help reduce the symptoms of ulcerative colitis and achieve clinical remission, which means the symptoms are significantly reduced or disappear. The trial aims to evaluate how well this medication works, how safe it is, and how well patients can tolerate it over time.

Investigated Diseases:

Colitis ulcerative

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon, also known as the large intestine. It is characterized by inflammation and ulceration of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease typically begins in the rectum and may extend continuously to involve the entire colon. The inflammation causes the colon to empty frequently, resulting in diarrhea. Over time, the inflammation can lead to the formation of ulcers, which are small open sores that can bleed and produce pus. The progression of ulcerative colitis can vary, with periods of active symptoms followed by times of remission.

Trial ID:

2023-509544-10-00

Protocol code:

1486-0006

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on BI 3032950 for Patients with Moderate to Severe Ulcerative Colitis

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