Clinical trials located in

Leuven

Leuven city is located in Belgium. Currently, 20 clinical trials are being conducted in this city.

Leuven, a historic city in Belgium, is renowned for its vibrant culture and rich heritage. Home to the oldest Catholic university in the world, the University of Leuven, founded in 1425, it’s a hub of academic excellence. The city boasts the 15th-century Town Hall, an architectural masterpiece with its ornate Gothic facade. Leuven is also famous for its beer culture, being the birthplace of several renowned breweries, including Stella Artois. The M-Museum Leuven adds a contemporary touch, showcasing modern art within its striking design.

  • CT-EU-00121056

    Testing BI 764198 for Kidney Disease (FSGS): A 4-Month Study

    This study is focused on individuals with a kind of kidney disease called Focal Segmental Glomerulosclerosis (FSGS). The purpose is to see if a drug named BI 764198 can improve kidney health for people with FSGS. There will be three different doses of BI 764198 tested in the study.

    Participants in the study will be divided into four groups randomly. Three groups will receive different doses of BI 764198, and one group will receive a placebo. The study will last about four months. For approximately three months, participants will take a BI 764198 capsule or placebo capsule daily.

    Participants will visit the study site around ten times. It is possible to participate from home, in which case a research nurse will visit for the study visits. Kidney health will be checked by analyzing urine samples that participants collect at home. The results will be compared between the different groups at the end of the study. Throughout the study, doctors will also regularly monitor the general health of participants.

    • BI 764198
    • placebo
  • Comparison of Olorofim and AmBisome® for Treating Invasive Aspergillosis in Patients Who Cannot Use Azole Therapy

    This study focuses on patients dealing with a serious fungal infection called Invasive Aspergillosis (IA). This infection is known to be particularly dangerous for people with weakened immune systems. Two drugs will be compared in this study: Olorofim (also known as F901318) and AmBisome® (liposomal amphotericin B). These drugs are used to treat patients who have a confirmed or suspected IA infection.

    AmBisome® is an established treatment, while Olorofim is a newer medication that works differently. This new drug aims to provide an alternative for patients who don’t respond well to existing therapies.

    The purpose of this study is to compare the effectiveness and safety of Olorofim with AmBisome®, followed by standard care according to medical guidelines. Patients will receive one of the treatments, and their response will be monitored over several months.

    Patients will start with either Olorofim or AmBisome® for a set period, then switch to the standard care recommended by their doctors. This approach allows researchers to understand how well each treatment works and what side effects might occur.

    Participation includes regular follow-ups and assessments to monitor the patient’s health, response to the medication, and any potential side effects. The ultimate goal is to find the best possible treatment for IA, improving outcomes for patients affected by this serious fungal infection.

    • AmBisome®
    • olorofim
  • Baricitinib study in children with juvenile idiopathic arthritis

    This clinical trial is designed to test whether Baricitinib is safe and effective in the treatment of systemic juvenile idiopathic arthritis in children aged 1 to 18 years. Participants will be assigned to one of two groups. In the first group, some participants will receive Baricitinib and others Tocilizumab as the reference drug. In the second group, all participants will receive Baricitinib.

    The primary objective of the study is to evaluate the percentage of participants who experience at least a 30% improvement in disease symptoms after 12 weeks of treatment according to the modified American College of Rheumatology Pediatric Response Criteria (PediACR30). Baricitinib is administered orally and Tocilizumab is administered by subcutaneous injection.

    • Tocilizumab
    • baricitinib
  • Study of Pembrolizumab/Quavonlimab Combination vs Other Treatments for Colorectal Cancer

    This here clinical trial is aimin’ to take a good look at a new combination treatment called co-formulated pembrolizumab/quavonlimab for folks with stage IV colorectal cancer that’s got that microsatellite instability-high or mismatch repair deficient business goin’ on. The main goal is to see how well this new combo treatment works at shrinkin’ them tumors, compared to some other treatments out there.

    Now, the real important part is that the doctors’ll be keepin’ a close eye on how many folks get what they call an objective response, meanin’ their tumors either disappear completely or shrink down by at least 30%. They’ll be trackin’ this over a span of up to around 50 months to get a good picture of how effective this new treatment is.

    Safety’s always a top priority too, so the doctors’ll be watchin’ out for any side effects or issues that might crop up with this new combo treatment. It’s all about findin’ the best way to fight that cancer while keepin’ folks as comfortable as possible.

  • Study of Fidrisertib/IPN60130 in the treatment of Fibrodysplasia Ossificans Progressiva (FOP)

    The aim of this study is to test a new drug called fidrisertib (also known as IPN60130) to treat a rare disease called Fibrodysplasia Ossificans Progressiva, or FOP. FOP is a grave disease that causes bones to start growing in places they shouldn’t, such as muscles and soft tissues. This causes a lot of pain, swelling, and stiffness in the joints, making movement difficult.

    In the study, some participants will be given the new drug fidrisertib at two different doses, and others will be given a dummy treatment called a placebo. Researchers will monitor the situation closely, performing special tests called low-dose whole-body computed tomography (WBCT) to measure new bone growth. For some older participants, they may also use another type of test called fluorine-18-labeled sodium fluoride positron emission tomography – computed tomography to check bone growth.

    • IPN60130
    • placebo
  • Study assessing the effectiveness of Tebentafusp administered alone and in combination with Pembrolizumab in the treatment of advanced melanoma

    The aim of this study is to test new treatments for people with advanced skin melanoma that does not respond well to other therapies. The main focus was on a new experimental drug called tebentafusp, which is a special type of protein that helps the body’s immune system recognize and attack cancer cells.

    The study divided patients into three different groups. One group will receive tebentafusp alone. Another group will receive tebentafusp in combination with another immunotherapy drug called pembrolizumab. The third group will receive the treatment that the doctor thinks is best for the patient – this could be another experimental drug, standard therapy, or simply supportive care.

    Scientists are primarily focusing on the effectiveness of these treatments in shrinking tumors and extending patient survival. They will also monitor closely for any side effects to make sure the treatment is safe. The study is expected to last about two years and will include frequent check-ins to monitor patient responses.

    • Tebentafusp
    • Pembrolizumab
  • Study of the drug combination mRNA-4157/V940 and Pembrolizumab in the treatment of melanoma

    The aim of this clinical trial is to test whether a new drug called mRNA-4157/V940 in combination with pembrolizumab can help prevent the recurrence of melanoma in people who have already had it. Currently, mRNA-4157/V940 is what is called “individualized neoantigen therapy,” which means it is a therapy created specifically for each patient based on their cancer cells. Doctors give this drug along with pembrolizumab, a drug that helps the immune system fight cancer cells.

    The main goal of this study is to determine whether taking V940 and pembrolizumab together is more effective in preventing melanoma recurrence than taking pembrolizumab alone. Researchers will closely monitor how long it takes for the cancer to return or spread. The study will last for approximately 74 months.

    • mRNA-4157/V940
    • placebo
    • Pembrolizumab
  • Efficacy and safety study of rosnilimab in moderate to severe rheumatoid arthritis

    This study will evaluate the effectiveness and safety of Rosnilimab in patients with moderate to severe rheumatoid arthritis. Rosnilimab is an antibody that activates the PD-1 receptor, also known as ANB030. Patients will be randomly assigned to receive Rosnilimab or placebo.

    The main aim of the study is to assess changes in the 28-Joint Disease Activity Index based on the concentration of C-reactive protein (DAS28-CRP) after 12 weeks of treatment. DAS28-CRP is a validated tool that assesses disease activity based on the number of painful and swollen joints and the concentration of C-reactive protein in the blood. A reduction in DAS28-CRP indicates an improvement in the patient’s condition.

    This study aims to test whether Rosnilimab is effective and safe in the treatment of rheumatoid arthritis. If the results are promising, this drug could become a new treatment option for patients suffering from this disease.

    • placebo
    • Rosnilimab
  • Study on Ravulizumab’s effect on Immunoglobulin A Nephropathy

    The study is looking into the effectiveness of a medication called ravulizumab for adults who have a kidney condition known as Immunoglobulin A Nephropathy (IgAN). This condition can lead to kidney damage over time, and the study aims to find out if ravulizumab can help reduce the amount of protein lost in urine—a common problem in IgAN—and slow down the decrease in kidney function.

    In this study, about 450 participants who are at a high risk of their disease getting worse will be chosen. These participants must have been on stable treatment for their IgAN for at least three months before the study starts. They will then receive either ravulizumab or a placebo, which is a treatment with no active drug, through an IV infusion based on their weight. The main goal is to see if those who receive ravulizumab have a significant improvement in their condition compared to those who receive the placebo.

    The study will have two main checkpoints. The first one, at Week 34, will check how much protein is in the urine, and the second one, at Week 106, will assess how well the kidneys are filtering waste from the blood. Additionally, a smaller group of participants with more advanced kidney issues will receive ravulizumab to further explore its effects.

    After the study ends at Week 106, participants will have the option to continue receiving ravulizumab in a follow-up period to see how long-term treatment affects their condition. This study is a chance for people with IgAN to potentially slow down their disease progression and improve their quality of life.

    • placebo
    • Ravulizumab
  • Study on the effectiveness of Givinostat in Non-Walking Duchenne Muscular Dystrophy Patients

    This clinical trial is focused on testing the effectiveness, safety, and how well patients can tolerate a medication called Givinostat for those who have Duchenne Muscular Dystrophy (DMD) and can no longer walk. The study is designed for male pediatric patients aged between 9 to less than 18 years. A total of 138 participants will be involved, and they will be divided into two groups. One group will receive Givinostat, and the other group will receive a placebo, which is a substance with no therapeutic effect, designed to mimic Givinostat. This division will be done randomly and both the patients and the doctors will not know who is receiving the actual medication and who is receiving the placebo, making this a double-blind study.

    The main goal of this study is to see if Givinostat can help reduce muscle decline in patients with DMD who cannot walk, by looking at changes in upper limb function after 18 months of treatment. The safety and tolerability of Givinostat in these patients will also be closely monitored.

    Participants will be involved in the study for about 20 to 21 months, which includes a 4-week screening period to confirm eligibility, 18 months of treatment, and a follow-up period. At the end of the treatment period, all participants, regardless of which group they were in, will have the option to join a long-term safety study where they will receive Givinostat.

    • Givinostat
  • Robotic-Assisted tPA Injection for Subretinal Hemorrhage Treatment

    The RoTIS study is an innovative research project aimed at improving the treatment for patients suffering from subretinal hemorrhage, a condition often associated with age-related macular degeneration. This condition can lead to a significant decrease in vision due to bleeding underneath the retina. Traditionally, treatments have involved manually injecting medication into the affected area to help clear the hemorrhage. However, this study introduces a cutting-edge approach by utilizing a robotic stabilizer to assist in the precise and stable injection of a medication called tPA directly into the subretinal space.

    During the surgery, which is part of your standard care, the surgeon will use a very thin needle, guided by a robot, to inject the tPA. This method aims to form a small bubble (bleb) in the subretinal space, helping to manage the hemorrhage more effectively. The goal is to ensure that the needle is placed accurately and remains stable for up to three minutes to allow for optimal treatment delivery.

    What makes this study particularly unique is the use of a robotic stabilizer. This tool is designed to reduce any tremors from the surgeon’s hand, ensuring the needle is precisely positioned and remains still during the injection. This level of precision is crucial, especially when dealing with delicate structures in the eye.

    Throughout the procedure, the surgical area will be closely monitored using a special type of imaging technology (iOCT) integrated into the surgical microscope. This allows the surgeon and the research team to observe the formation of the bleb in real-time, ensuring the treatment is delivered as intended.

    The RoTIS study represents a significant advancement in the treatment of subretinal hemorrhage, potentially offering patients a more effective and less invasive option. By participating in this study, you will be at the forefront of medical innovation, contributing to the development of new treatments that could benefit many people in the future.

  • Testing a new drug for advanced prostate cancer

    This trial compares a new drug called AZD5305 with a placebo in men who have a specific kind of prostate cancer that has not responded to usual treatment methods. It’s a large trial, with around 1800 participants, and the main aim is to see whether the new treatment can help slow down the disease for longer than current treatments. Participants will be assigned to two different groups, and they will not know whether they’re receiving the real drug or the placebo. Their health will be monitored closely, with regular scans to check the progress of the cancer. The trial will also look at any side effects of the treatment and how it affects the patients’ ability to do their daily activities.

    • Enzalutamide/Xtandi
    • Darolutamide/Nubequa
    • Abiraterone Acetate/Zytiga
    • Saruparib
  • Continued Parsaclisib treatment for B-cell cancer patients

    This is a phase II clinical trial focused on providing continuation of treatment with a drug called parsaclisib to people diagnosed with B-cell malignancies. The main goal of this study is to expand the treatment regimen established in the previous study. Study participants will receive parsaclisib as a stand-alone therapy (monotherapy) or in combination with other therapeutic agents, which may include itacitinib, ruxolitinib or ibrutinib. The study aims to facilitate participants’ ongoing care and contribute to the broader field of medical research by collecting data on the effectiveness and safety of prolonged use of parsaclisib.

    • Ibrutinib
    • Ruxolitinib
    • Itacitinib
    • Parsaclisib
  • Extended safety study for participants using spartalizumab alone or combined

    This study relates to a type of medication called spartalizumab. The goal is to find out if this medicine, when given alone or with other treatments, is safe and doesn’t cause any unwanted side effects. The study is open to people who have already been involved in past studies for spartalizumab. The reason for this is to keep giving these people access to the treatment while also continuously assessing its safety.

    • spartalizumab/PDR001
  • Stomach cancer treatment comparison: trastuzumab deruxtecan vs. ramucirumab & paclitaxel

    This is a thorough comparison study to measure the effectiveness and safety of two treatment paths. It’s designed for individuals who have experienced progression regarding a stomach (gastric) cancer, or cancer of the gastro-esophageal junction (GEJ). The study focuses on those with HER2-positive gastric or GEJ who have previously undergone a trastuzumab-containing regime but have not received further systemic therapy.The research compares the use of trastuzumab deruxtecan, a potent anti-cancer agent, and the combined use of ramucirumab and paclitaxel. The study’s primary goal is to evaluate the overall survival rate, while secondary aims involve examining progression-free survival, response duration, disease control, safety, pharmacokinetics, and immunogenicity.In the study, participants are fairly and randomly assigned to receive one of two treatments. This is crucial in understanding the superiority and safety of these treatment paths, and this knowledge may inform future approaches to treating these types of cancer.

    • Ramucirumab
    • Trastuzumab deruxtecan
    • Paclitaxel
  • Study on Seladelpar in Patients with Primary Biliary Cholangitis (PBC)

    Patients with Primary Biliary Cholangitis (PBC) can participate in a clinical trial involving the drug Seladelpar, available in 5 mg and 10 mg capsule forms. The trial aims to evaluate the long-term safety and tolerability of this drug, also known by the code MBX-8025.

    Seladelpar is being tested on a group of approximately 500 patients to determine its long-term tolerability and effectiveness in individuals with PBC. The objective is also to assess the drug’s impact on patient-reported symptoms, such as itching (pruritus).

    The study includes individuals who have previously participated in PBC studies involving seladelpar. Participants will be monitored for 60 months to collect data on potential side effects and laboratory test results.

    The overall goal of the study is to improve the treatment of patients with Primary Biliary Cholangitis by thoroughly investigating the new drug in terms of its safety and efficacy.

    • Seladelpar
  • Advanced endometrial cancer treatment with acasunlimab and pembrolizumab

    In this trial, scientists are trying out a new treatment for advanced endometrial cancer. This treatment involves using a combination of two drugs, acasunlimab (also referred to as GEN1046) and pembrolizumab, to fight the cancer. The study aims to see how well this treatment works and what side effects might happen. Patients taking part in the trial will be divided into two groups and will be given the trial treatment for up to two years. The total time for which each patient will be monitored is about three years. The treatment’s success will be measured by counting how many patients see their cancer shrink or go away for a period of time. Doctors will be closely watching what happens from the first day of the treatment, tracking how the tumours change and noting down any unusual health happenings that could be related to the trial.

    • Acasunlimab/GEN1046
    • Pembrolizumab
  • Testing the safety and effectiveness of astegolimab for chronic lung disease

    The aim of this study is to see if a drug called astegolimab will be effective and safe in people with a lung disease called chronic obstructive pulmonary disease, or COPD. During this study, patients will be divided into 2 groups. One group of patients will receive the drug, the remaining patients will receive a placebo to compare the results. Both groups will not know what they are getting. The study was particularly interested in people suffering from COPD (chronic obstructive pulmonary disease) who smoked or still smoke and often get sick because of it.

    • Astegolimab
  • Treatment of lung cancer before and after surgery using various drug combinations

    The NeoCOAST-2 trial is a phase II study evaluating various combinations of anticancer therapies in patients with resectable early-stage non-small cell lung cancer. This study is divided into two stages. The first stage occurs before surgery (neoadjuvant treatment), the next stage after surgery (adjuvant treatment). Researchers will use a drug called Durvalumab, which will be combined with various drugs. The goal is to determine the safety and effectiveness of these regimens for treating early-stage lung cancer, potentially improving treatment outcomes.

    The first group of patients will receive Oleclumab, Durvalumab and a strong drug – Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin. After surgery, they will be given Oleclumab and Durvalumab.

    Patients in the second group will receive Monalizumab, Durvalumab and drugs combined with platinum before surgery. After surgery, they will be given Monalizumab and Durvalumab.

    In the third group, MEDI5752 and drugs combined with platinum are administered before surgery. After surgery, patients will only receive MEDI5752.

    People from group four receive Dato-DXd, Durvalumab, Carboplatin or Cisplatin before surgery. After surgery, they will be given Durvalumab.

    Participants in the fifth group will receive AZD0171, Durvalumab and platinum doublet chemotherapy before surgery. After surgery, patients will receive AZD0171 and Durvalumab.

    • AZD0171- new potential medication for advanced cancer
    • Oleclumab
    • Monalizumab
    • MEDI5752
    • Dato-DXd
    • Pemetrexed
    • Paclitaxel
    • Cisplatin
    • Carboplatin
    • Durvalumab
  • Testing tozorakimab’s effect on chronic lung disease symptoms

    This study is all about testing a new drug, Tozorakimab, for people who have COPD – a lung disease that makes it difficult to breathe—and have had a bad flare-up in the past year. The researchers will give some people the new drug and some people a placebo (a dummy treatment) and see which works best. The drug is delivered in a shot under the skin, and all the people in the study will also keep taking their usual COPD medicines. The main things the researchers will be looking at are whether the new drug can reduce the number of flare-ups, improve quality of life (measured using a questionnaire), reduce the need for rescue medication and if it changes the results of breathing tests.

    • Tozorakimab

See more clinical trials in other cities in Belgium:

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