Clinical trials located in

Monza

Monza city is located in Italy. Currently, 20 clinical trials are being conducted in this city.

Monza, nestled in Italy’s Lombardy region, is renowned for its rich history and cultural heritage. This city is home to the Monza Park, one of Europe’s largest enclosed parks, and the ancient Monza Cathedral, a marvel of Lombard-Gothic architecture. Monza is also globally recognized for the Autodromo Nazionale Monza, a historic race track that has hosted the Formula One Italian Grand Prix since 1922, making it a pivotal location in the world of motorsport. The city’s blend of historical sites, natural beauty, and sporting significance makes it a unique mosaic of Italian culture and tradition.

  • CT-EU-00089037

    Studying the safety of a new medicine in treating Primary biliary cholangitis (PBC)

    The study is aimed at patients suffering from primary biliary cholangitis (PBC), a disease causing inflammation and narrowing of the bile ducts. The therapy involves the administration of the drug A3907, also known as Ritivixibat.

    The main goal of the study is to evaluate how safe and well-tolerated A3907 is in individuals with PBC. Additionally, doctors will examine how participants’ bodies respond to the drug and what changes occur during treatment.

    Adults aged 18 to 75 with clinical symptoms of PBC for at least six months can participate. The study includes various dosing groups of A3907 to understand which dose is most effective and safe.

    An important aspect of the study is that participants must be clinically stable for at least three months prior to its commencement. Women of childbearing age must use appropriate contraceptive methods, and all participants must be willing to sign informed consent.

    The study does not include individuals with other chronic liver diseases, including cirrhosis, or those who have had liver transplants or other internal organ surgeries in the past.

  • Study on the use of Volixibat for the treatment of pruritus in patients with primary cholangitis (PBC)

    The purpose of this clinical trial is to evaluate the efficacy and safety of an investigational drug called volixibat in patients with pruritus caused by primary cholangitis. The study aims to understand how volixibat affects the treatment of pruritus associated with this disease and to evaluate its possible effect on disease progression.

    Study participants will be randomly assigned to a group receiving volixibat or placebo. Volixibat will be administered as oral capsules twice daily. The main goal of the study is to measure the average change in daily pruritus scores using a special Adult Itch Reported Outcome (Adult ItchRO) questionnaire. Adult ItchRO is an 11-point scale for assessing pruritus severity, where 0 means no pruritus and 10 means the worst possible pruritus. The study will run from baseline to week 28.

    • Volixibat
    • Placebo
  • Study of Elafibranor in the treatment of adult patients with Primary Biliary Cholangitis (PBC)

    The clinical trial is aimed at adult patients with confirmed primary cholangitis (PBC). Patients with this condition have an inadequate response or intolerance to ursodeoxycholic acid (UDCA), a drug used to treat PBC.

    Primary cholangitis is a disease that slowly progresses and leads to damage to the bile ducts in the liver. This causes a build-up of bile acids, which further damages the liver. As the disease progresses, scarring of the liver may develop (cirrhosis). PBC is also associated with numerous symptoms, such as itching and fatigue, and may lead to the need for a liver transplant.

    The study evaluates the effectiveness and safety of a drug called elafibranor at a dose of 80 mg daily. The study will compare elafibranor with a placebo, an inactive substance administered for control purposes. The main goal of the study is to test the effectiveness of elafibranor. The safety of long-term use of this medicine and its effect on symptoms such as itching and fatigue will also be checked.

    • Elafibranor
  • Study on the effectiveness and safety of M281 in adults with warm Autoimmune Hemolytic Anemia

    The study focuses on Warm Autoimmune Hemolytic Anemia (wAIHA), a condition where the immune system mistakenly destroys red blood cells. This leads to symptoms like fatigue, weakness, and jaundice (yellowing of the skin or eyes). The trial examines the effects of a therapy named M281 (Nipocalimab). The purpose of the study is to evaluate the efficacy and safety of M281. Patients participating in the study will receive either M281 or a placebo. It aims to compare improvements in health and monitor any side effects.

    The study structure is as follows:

    Double-blind period: This lasts for 24 weeks, where participants will be randomly assigned to one of three groups. One group will receive M281 every 4 weeks, alternating with a placebo every 4 weeks. Another group will receive M281 every 2 weeks, and the third group will receive a placebo every 2 weeks.

    Open-label extension period: This phase extends for 144 weeks, where all participants will receive M281, either every 2 weeks or every 4 weeks.

    Participants will be monitored for 8 weeks after the last dose to check for any ongoing effects of the treatment. The study aims to provide comprehensive information about the effectiveness and safety of M281 in treating wAIHA.

    • M281
    • placebo
  • Study on combining two drugs – Fianlimab and Cemiplimab in patients with previously untreated melanoma

    This study examines two drugs, fianlimab and cemiplimab, given together for the treatment of melanoma. The main goal is to see how effective this drug combination is in treating melanoma compared with pembrolizumab, which is already approved for the treatment of melanoma in adults. The study will also look at whether there are any differences in the effects of these experimental drugs in adolescents and adults.

    Scientists also want to learn about other key issues: what side effects may occur from taking these experimental drugs, how much of the drugs enter the bloodstream over time, and whether the body produces antibodies to the drugs that could make them less effective or cause side effects. They will also check whether taking medications improves patients’ quality of life. Fianlimab and cemiplimab will be administered by intravenous infusion, and pembrolizumab will be administered by intravenous infusion.

    • placebo
    • Fianlimab
    • Cemiplimab
    • Pembrolizumab
  • Study of asciminib dosing and safety in pediatric patients with Chronic Myeloid Leukemia

    This study is designed to determine the appropriate dosing and assess the safety of the drug asciminib for children and teenagers who have a specific type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML-CP). These patients have previously been treated with at least one other medication known as a tyrosine kinase inhibitor (TKI). The study involves giving different doses of asciminib to see how well the drug works and how safe it is in young patients. The study will enroll participants into two age groups and will follow them over a five-year period to observe the effects of the treatment.

    • Asciminib
  • 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
  • Assessing imatinib inhalation therapy for pulmonary arterial hypertension

    This clinical study aims to evaluate the safety and efficacy of an inhaled treatment called imatinib (AV-101) for patients with Pulmonary Arterial Hypertension (PAH). The trial is divided into two parts: Phase 2b and Phase 3. In Phase 2b, researchers will test three doses of AV-101 to identify the optimal dose for Phase 3. They will check this by measuring the resistance of the lung vessels — less resistance means the medicine is working. In the following Phase 3, the primary outcome will be the change in the 6-minute walk distance after 24 weeks of treatment compared to a placebo. Participants must be between 18 and 75 years old, have a diagnosis of PAH, and meet specific criteria regarding their disease severity and concomitant therapy.

    • Imatinib/AV-101
  • Testing a new inhaled drug for pulmonary arterial hypertension

    This study focuses on the efficiency and safety of a new inhaled drug – MK-5475 – for patients suffering from Pulmonary Arterial Hypertension (PAH). The study is divided into two parts: phase 2 and phase 3. In phase 2, the researchers will compare three different doses of MK-5475 with a placebo over a base period of 12 weeks. The goal is to find out if any of the doses can decrease the patient’s pulmonary vascular resistance (PVR), which is the resistance that the heart must overcome to pump blood through the lungs. In Phase 3 of the study, the best performing dose from Phase 2 will be used to confirm its long-term effectiveness, safety, and tolerability over a 12-week base period with a follow-up period of up to five years. The focus is to see if this dose is better than a placebo in improving the patient’s walking distance over 6 minutes. The study aims at improving the quality of life and physical health of PAH patients with the help of the new drug.

    • MK-5475
  • Ceralasertib & durvalumab vs docetaxel in advanced lung cancer study

    This is an open-label study titled LATIFY, which means everyone will know the type of treatment they are receiving. The study team is looking into a specific type of lung cancer, called Non-Small Cell Lung Cancer (NSCLC) which did not get better after previous treatments. Two treatments will be tested, a new combination of ceralasertib plus durvalumab, compared to a commonly used treatment, docetaxel. Doctors will track participants’ health over time to see which treatment helps people live longer. Understanding the results will help doctors responsibly give the best treatment for patients with this type of lung cancer.

    • Ceralasertib
    • Durvalumab
    • Docetaxel
  • Examining repotrectinib vs crizotinib in advanced lung cancer treatment

    This trial is named TRIDENT-3, it’s for people who have a particular type of lung cancer that has spread beyond the lungs (advanced or metastatic). The lung cancer for this study is called ‘Non-Small Cell Lung Cancer’ (NSCLC) and it’s positive for an important part of the cells called ‘ROS1.’ The trial will compare two medicines: repotrectinib and crizotinib. People participating in the trial have not been treated with a group of drugs called ‘Tyrosine Kinase Inhibitors’ (TKIs) before. The main goal of this study is to see how effective and safe these two drugs are for these patients.

    • Repotrectinib
    • Crizotinib
  • Safety study of tafasitamab with lenalidomide for Diffuse Large B-Cell Lymphoma patients

    In this study, a novel approach to the treatment of Diffuse Large B-Cell Lymphoma (DLBCL) is being investigated. This type of cancer may have either recurred or not responded to previous treatments. The experimental intervention involves the use of two drugs: Tafasitamab, administered intravenously, and Lenalidomide, a oral medication. The study is focused on individuals who have undergone one to three prior treatments and are currently ineligible for intensive chemotherapy or a stem-cell transplant. The study is conducted in an open format, providing transparency regarding the substances being tested. Regular monitoring will be implemented to detect any potential issues and assess the concentration of the medications in participants’ blood.

    • Tafasitamab
    • Lenalidomide
  • Study on the safety of T-DXd and immunotherapy in Advanced or Metastatic Non-Small Cell Lung Cancer

    The DESTINY-Lung03 trial aims to understand how safe and effective a medicine called trastuzumab deruxtecan (T-DXd) is for individuals with a form of lung cancer known as HER2 over-expressing non-small cell lung cancer (NSCLC). T-DXd will be combined with other cancer-fighting medicines identified as Immunotherapy Agents. Some patients will receive additional chemotherapy, others will not. The plan is to test different dosing levels of T-DXd and Immunotherapy Agents in different parts of the study to understand what dose is most effective and safe. We’ll also test T-DXd along with a medicine called MEDI5752 to see how this combination affects the same forms of lung cancer.

    • MEDI4736 (Durvalumab)
    • T-DXd (Trastuzumab deruxtecan)
    • MEDI5752
    • Pemetrexed
    • Cisplatin
    • Carboplatin
  • Testing inhaled imatinib for pulmonary arterial hypertension

    This study is about a new medicine called imatinib (AV-101) which you breathe in as a dry powder. It’s for people who have a health problem called Pulmonary Arterial Hypertension (PAH) – when blood pressure is too high in the arteries that go from the heart to the lungs. The imatinib study will go through two stages. In the first stage, the researchers will try three different amounts of the medicine to find the best one. It will be based on how much it can reduce the resistance in the blood flow in the lungs. In the second stage, they it will be seen how far patients can walk in 6 minutes after taking the medicine for 24 weeks. The study also uses scoring systems to measure how much risk or symptoms a patient has. A higher score means more risk or symptoms.

    • imatinib/ AV-101
  • Study investigating new medicine for advanced metastatic breast cancer

    A clinical study is investigating the impact and safety of a new medicine named ARV-471 (Vepdegrestrant), contrasting its effects with an already-used drug called fulvestrant (FUL). This research targets individuals suffering from advanced metastatic breast cancer, a disease that often spreads to various parts of the body and is challenging to control. ARV-471 will be given to half of the participants, with the other half receiving fulvestrant. The effects of both will be monitored over time. ARV-471 is consumed by mouth, while FUL is administered through injections.

    • Vepdegrestrant/ARV-471
    • Fulvestrant
  • Understanding trastuzumab deruxtecan treatment for advanced lung cancer

    This study is testing a new lung cancer treatment, Trastuzumab Deruxtecan, to see if it’s effective and safe for patients with a certain type of advanced lung cancer (Non-Small Cell Lung Cancer with HER2 mutations). Patients in the study either receive this new treatment or standard care (cisplatin or carboplatin + pembrolizumab + pemetrexed). The main goal is to see if the new treatment helps patients live longer without their cancer getting worse and to monitor any side effects.

    • Trastuzumab deruxtecan
    • Pemetrexed
    • Cisplatin
    • Carboplatin
    • Pembrolizumab
  • New lung cancer study: testing osimertinib before surgery

    The aim of this clinical trial is to evaluate the effectiveness of osimertinib, a drug that specifically targets the EGFR mutation, in patients with resectable non-small cell lung cancer. The study will involve three groups: one will receive standard chemotherapy, the second will receive a combination of osimertinib and chemotherapy, and the third will receive osimertinib alone. This phase III trial focuses on patients with a specific genetic mutation (EGFRm) in lung cancer. Key outcomes measured include tumor removal rate, survival rates and overall quality of life. The aim is to improve the standard of pre-operative treatment, which could potentially lead to better outcomes for lung cancer patients. The study also aims to understand the impact of osimertinib on this disease, particularly when combined with traditional chemotherapy, which will provide a comprehensive picture of potential benefits and risks.

    • Osimertinib
    • Carboplatin
    • Cisplatin
    • Pemetrexed
  • Sotatercept treatment study for new Pulmonary Hypertension patients

    This study is an important test where doctors are looking at how a drug called Sotatercept can help people struggling with Pulmonary Arterial Hypertension (or PAH for short). The goal is to see whether this drug can delay or prevent the condition from getting worse. PAH makes it really hard for patients to breathe because it affects lungs and heart. The testing process is being done in a fair and careful way. Half of the patients will get the drug, and the others will get a ‘placebo’ which doesnt contain any medicine. The doctors will look at the effect on patients over time. The study is looking specifically at patients who were recently diagnosed with PAH and are at risk for the disease to get worse.

    • Sotatercept
  • Use of tucatinib in combination therapy for HER2-positive breast cancer

    This study examines whether tucatinib, combined with other medications, is more effective than a placebo in treating HER2-positive breast cancer. The research will also identify any side effects from the drug combination. Participants in this study have advanced breast cancer that is either unresectable (cannot be surgically removed) or metastatic (spread throughout the body). Participants will be randomly assigned to receive either tucatinib or a placebo, without knowing which one they are receiving. This method ensures the study’s fairness and accuracy. Additionally, all participants will receive trastuzumab and pertuzumab, two drugs effective against this cancer type. These will be administered every 21 days, either intravenously or subcutaneously, depending on the specific drug and combination used. The study has two main groups: one receiving a placebo and the other tucatinib, both alongside trastuzumab and pertuzumab.

    • Pertuzumab
    • Tucatinib
    • Trastuzumab
  • Testing new treatments for non-small cell lung cancer

    This international study aims to assess the effectiveness and safety of various specialized treatments for individuals with non-small cell lung cancer (NSCLC). The study focuses on a multiple targeted therapies and immunotherapy. It aims to assess the treatments’ effectiveness and safety, tailored based on specific genetic markers in the patients’ tumors. The approach is personalized, hoping to improve outcomes by matching the right treatment to the right patient, based on their unique cancer profile.

    • Divarasib/GDC-6036
    • Alectinib
    • Entrectinib
    • Cobimetinib
    • Vemurafenib
    • Bevacizumab
    • Atezolizumab
    • Gemcitabine
    • Pemetrexed
    • Cisplatin
    • Carboplatin
    • Docetaxel

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