Clinical trials located in

Milan

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

Milan, Italy’s second-largest city, is a global capital of fashion and design. Founded by the Insubres, a Celtic people, it was later captured by the Romans in 222 BC. Milan is renowned for its rich historical heritage, including the iconic Duomo di Milano, a marvel of Gothic architecture, and the Santa Maria delle Grazie, which houses Leonardo da Vinci’s “The Last Supper.” The city is also a financial hub, home to the Italian Stock Exchange. Its vibrant cultural scene is reflected in its numerous museums, theaters, and galleries.

  • CT-EU-00121101

    Stem cell transplantation vs. drugs for immunosuppression in early systemic scleroderma

    The clinical trial concerns patients diagnosed with early diffuse systemic sclerosis (dcSSc). This study will compare two treatment strategies: autologous hematopoietic stem cell transplantation (HSCT) and immunosuppressive therapy.

    Immunosuppressive therapy includes intravenous cyclophosphamide (CYC) followed by oral mycophenolate mofetil (MMF).

    The aim of the study is to determine which of these two methods is most effective in the treatment of early-stage systemic sclerosis in terms of survival and prevention of organ failure.

    Participation in this study is possible for patients aged 18 to 65 years with diagnosed systemic sclerosis. Patients are divided into two groups: one will receive HSCT immediately, the other will undergo immunosuppressive therapy, with HSCT being a rescue option if there is no response to treatment.

    Measuring effectiveness will be based on multiple health metrics, such as event-free survival, overall survival, disease progression, number of patients requiring rescue therapy, and health-related quality of life.

  • Study of the safety and effectiveness of GLSI-100 in patients with HER2-positive breast cancer

    The study concerns the treatment of patients with HER2/neu-positive breast cancer. Treatment will include GLSI-100 immunotherapy and comparison to placebo. GLSI-100 consists of GP2 peptide and GM-CSF, protein substances that are designed to strengthen the body’s immune response, i.e. natural protection against diseases.

    The aim of this study is to determine how effective and safe GLSI-100 therapy is compared to placebo in preventing breast cancer recurrence after standard treatment. The study is aimed at people at high risk of disease recurrence who have completed both preoperative and postoperative therapy based on trastuzumab, a drug used to treat breast cancer.

    The study will assess invasive breast cancer-free survival (i.e. the time from the first dose of the drug to the moment of disease recurrence or death from any cause), invasive disease-free survival (i.e. the time from the first dose of the drug to the moment of any disease recurrence or new cancer), remote disease (i.e. time until disease recurrence in a place other than the breast or death).

    The study also includes an assessment of the participants’ quality of life both at the beginning and over the next 36 months, as well as an analysis of the body’s immune response to treatment.

  • Study of Trabectedin for Advanced Mesenchymal Chondrosarcoma

    Mesenchymal chondrosarcoma is a rare type of cancer that affects the connective tissues in the body, often found in bones or soft tissues. This study focuses on the potential benefit of a drug called trabectedin for patients aged 16 and older who have advanced mesenchymal chondrosarcoma that has either progressed locally or spread to other parts of the body, and who have already received at least one previous chemotherapy treatment.

    The purpose of the study is to explore the activity of trabectedin in treating this specific type of cancer. Trabectedin will be given through a continuous 24-hour infusion. The dose will be determined by the investigator, with the range being from 1.3 mg/m² to 1.5 mg/m² per cycle. Each participant will receive the treatment as the only experimental therapy in the study.

    Patients will be monitored at regular intervals to assess their response to the treatment and its effectiveness over time. The study will also track any adverse effects from the treatment, aiming to understand both the potential benefits and risks of using trabectedin for this cancer type.

    The study aims to provide more information on how trabectedin works in treating mesenchymal chondrosarcoma, which could potentially lead to better treatment options for patients with this rare and challenging disease.

    • Trabectedin
  • 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
  • Long-term safety and efficacy study of PTC518 for Huntington’s disease

    This study focuses on Huntington’s Disease and evaluates the long-term safety and effectiveness of the drug PTC518. Participants, who have previously completed related study phases, will continue taking PTC518 in doses of 5, 10, or 20 milligrams. The study aims to monitor the safety of long-term use and assess how the drug impacts biological markers and symptoms of the disease over a period of 30 months. This is an extension study where all participants will receive the active drug, ensuring continuous monitoring and evaluation of its effects.

    • PTC518
  • 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.

  • Pembrolizumab and electrochemotherapy performed using a cliniporator in the treatment of malignant melanoma

    This study is looking at the use of pembrolizumab (Keytruda) in combination with a treatment called electrochemotherapy (ECT) in people with malignant melanoma. The main goal is to see if combining these two treatments is safe and can improve the effectiveness of the therapy in shrinking tumors, both those on the surface of the skin and those found in the body.

    Electrochemotherapy involves using electrical pulses along with a drug called Bleomycin to kill cancer cells. This is thought to help the immune system better recognize and attack cancer. Pembrolizumab is an immunotherapy drug that inhibits the cells of the immune system that fight cancer. Scientists believe that by combining these two approaches, a better anti-tumor response can be achieved compared to using pembrolizumab alone.

    • Pembrolizumab KEYTRUDA®
  • To evaluate the effectiveness of nivolumab used alone and in combination with HBI-8000 in the treatment of unresectable or metastatic melanoma

    This is a study comparing two treatment options for patients with melanoma that cannot be surgically removed or has spread to other parts of the body. One treatment option is an investigational drug called Tucidinostat (HBI-8000) taken by mouth twice a week in combination with an approved drug called nivolumab given by intravenous infusion. Another option is a placebo taken orally twice a week, also in combination with nivolumab given by intravenous infusion.

    The primary goal of the study is to determine whether the combination of HBI-8000 and nivolumab is more effective than nivolumab alone in shrinking the tumor or preventing further tumor progression. The study will also assess the safety of the treatment combinations.

    Patients enrolled in the main study will be randomly assigned to receive either the HBI-8000 combination or a placebo combination. Treatment will continue for up to 2 years or until the cancer progresses, side effects worsen or the patient decides to withdraw from the study. The study will last up to 4 years and will include regular monitoring and follow-up visits.

    • Placebo
    • Tudicdinostat/HBI-8000
  • 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
  • A study comparing upadacitinib versus adalimumab in the treatment of rheumatoid arthritis

    This clinical trial is studying a new medication called upadacitinib for treating moderate to severe rheumatoid arthritis. Rheumatoid arthritis is a chronic condition that causes pain, stiffness, swelling, and loss of joint function. The study will compare upadacitinib, which is taken as an oral tablet once daily, to adalimumab (brand name Humira), which is an injection given under the skin every other week.

    The main goal is to see how effective upadacitinib is at reducing disease activity compared to adalimumab. The study will measure the percentage of participants who achieve a certain level of low disease activity based on a score called the DAS28-CRP, which looks at tender and swollen joints, overall disease activity, and inflammation levels.

    This is a double-blind study, meaning neither the participants nor the study doctors will know which treatment each participant is receiving. Participants will attend regular visits at a hospital or clinic for medical assessments, checking for side effects, and completing questionnaires. There may be a higher treatment burden compared to standard care. The study is designed to assess the safety and effectiveness of upadacitinib compared to adalimumab in treating moderate to severe rheumatoid arthritis.

    • Adalimumab
    • Upadacitinib
  • Study on the Safety and Effectiveness of INCB057643 for Myelofibrosis and Other Myeloid Neoplasms

    This clinical trial is focused on evaluating the safety, tolerability, and initial effectiveness of a medication called INCB057643, either on its own or in combination with another drug known as ruxolitinib. It is designed for participants who are dealing with myelofibrosis or other advanced myeloid neoplasms, which are types of blood disorders. The study aims to understand how well participants can handle the treatment and to observe any potential benefits or side effects that may occur during the trial. The treatment’s impact will be measured by monitoring the number of treatment-related adverse events, which includes any new or worsening symptoms following the start of the medication. This study is an important step towards finding new treatment options for individuals with myelofibrosis and related conditions, offering hope for better management of these diseases.

    • INCB057643
    • Ruxolitinib
  • ARTEMIS study: Protecting kidney health in heart surgery patients with Ravulizumab

    The ARTEMIS study aims to find a new way to protect people with chronic kidney disease (CKD) undergoing heart surgery requiring the use of a heart-lung machine, also known as cardiopulmonary bypass (CPB). The main aim of this study is to see if a single dose of a drug called ravulizumab given intravenously can reduce the risk of serious kidney problems after surgery, compared with a placebo. Kidney issues are grouped under serious adverse events, and investigators will monitor them for up to 90 days after surgery. The study is carefully controlled and participants will not know whether they are receiving ravulizumab or a placebo to ensure the results are unbiased. This is an important test for people with chronic kidney disease undergoing heart surgery because it may lead to better outcomes and a lower risk of kidney damage after surgery.

    • placebo
    • Ravulizumab
  • Evaluating the Safety and Effectiveness of DYNE-101 for Myotonic Dystrophy Type 1 Patients

    This clinical trial is focused on evaluating a new treatment called DYNE-101 for individuals with Myotonic Dystrophy Type 1 (DM1). The main goal is to see how safe and tolerable this treatment is when given through an intravenous (IV) infusion, which means directly into the vein. The study is designed to carefully monitor how participants respond to multiple doses of DYNE-101 over time.

    The trial is structured into four main phases. It starts with a Screening Period that lasts up to 8 weeks to determine eligibility. Following this, there is a multiple-ascending dose (MAD) Placebo-Controlled Period that goes on for 24 weeks, where the safety and effectiveness of different doses of DYNE-101 are compared against a placebo (a treatment with no active drug). This is to ensure that any changes in participants’ health can be accurately attributed to the treatment. After this phase, there is a Treatment Period of another 24 weeks, where all participants receive DYNE-101. The study concludes with a Long-Term Extension (LTE) Period lasting 96 weeks, aimed at understanding the long-term impacts of the treatment.

    One of the key aspects being monitored throughout the study, up to Week 145, is the number of participants who experience any treatment-emergent adverse events (TEAEs), which are any new or worsening health issues that occur during the trial.

    This study represents an important step towards finding a new treatment option for those living with Myotonic Dystrophy Type 1, with a strong focus on safety and the overall well-being of the participants.

    • DYNE-101
  • Study on the effectiveness and safety of BBP-418 for Limb Girdle Muscular Dystrophy 2I patients

    This clinical trial is focused on a new treatment option for individuals diagnosed with Limb Girdle Muscular Dystrophy 2I (LGMD2I). This study is designed to explore the efficacy and safety of a medication called BBP-418 (Ribitol), which is administered as an oral solution. The medication is in the form of granules that are mixed with water to create a drinkable solution.

    The aim is to include participants aged 12 to 60 years old, covering a wide range of individuals affected by LGMD2I. Throughout a 36-month period, the study will closely monitor changes in the muscle function and overall health of the participants to determine the effectiveness and safety of BBP-418 in treating LGMD2I.

    A key aspect being observed is the change from baseline in the North Star Assessment for Limb Girdle Muscular Dystrophy after 36 months of treatment. This will aid in understanding the impact of BBP-418 on muscle function. In addition, the frequency and severity of any treatment-emergent adverse events will be tracked to ensure the medication’s safety over the long term.

    This study is a randomized, placebo-controlled, double-blind study, meaning participants will be randomly assigned to receive either the BBP-418 treatment or a placebo, with neither the participants nor the study staff aware of which group they are in. This approach helps ensure the reliability of the study results.

    • BBP-418 (ribitol)
  • A study of relacorilant in the treatment of hypercortisolism (Cushing’s syndrome) in patients with adrenal adenoma

    This clinical trial focuses on testing the effectiveness and safety of a drug called relacorilant in the treatment of patients with hypercortisolism (Cushing’s syndrome). Hypercortisolism is a condition in which there is too much cortisol in the body, which may occur due to an adenoma or hyperplasia of the adrenal glands that secrete cortisol. This condition can lead to diabetes or impaired glucose tolerance and/or uncontrolled high blood pressure.

    The study is in phase III, which means that the effectiveness and safety of the drug are compared with placebo. This is a double-blind, placebo-controlled study, which means neither participants nor researchers know who is receiving the actual drug and who is receiving the placebo to ensure unbiased results.

    Participants in this study will be randomly assigned to receive relacorilant or placebo for 22 weeks. The main goals of the study are to see how well relakorilant can improve blood sugar levels in patients with diabetes or impaired glucose tolerance, and how it affects blood pressure in people with high blood pressure. Additionally, the study will monitor the safety of relacorilant by recording any adverse events that occur.

    People who complete the study may have the opportunity to continue with a follow-up study, which may provide further information on the long-term effects and benefits of relacorilant.

    • Relacorilant
  • Exploring tirzepatide as a new treatment for Wolfram Syndrome type 1

    The researchers introduce a pioneering clinical trial aimed at exploring a new treatment option for individuals with Wolfram Syndrome Type 1 (WS1), a rare genetic disorder. This study focuses on the use of tirzepatide, a medication that has shown promise in addressing some of the critical aspects of WS1, including diabetes and possibly other symptoms related to the disease.

    Wolfram Syndrome is a challenging condition that typically emerges in childhood, leading to diabetes, vision loss, hearing problems, and sometimes diabetes insipidus. Currently, there is no cure or treatment known to halt or slow down the progression of WS1. However, this trial aims to change that by investigating the effectiveness of tirzepatide, a drug that targets specific bodily functions to potentially improve insulin production and stabilize blood sugar levels.

    The trial is designed as a phase 2 study, meaning the researchers will closely monitor the effects of tirzepatide over time in a group of participants with WS1.  Main goal is to see if this treatment can increase the body’s natural insulin production and help manage blood sugar more effectively. It will be assessed  by measuring changes in insulin production and response during the study.

    Participants will receive tirzepatide through a weekly injection, and  team of specialized clinicians and researchers will provide comprehensive care and follow-up.

    By joining this trial, patients will be at the forefront of research that could offer a new therapeutic option for  Wolfram Syndrome and contribute to our understanding of how to manage this and similar diseases more effectively.

    • Tirzepatide
  • Understanding the Genetic Link Between Beckwith-Wiedemann Syndrome and Female Reproductive Health

    This study focuses on understanding the connection between certain genetic variations and reproductive issues, including difficulties in getting pregnant, recurrent pregnancy loss, and a condition known as Beckwith-Wiedemann Syndrome (BWS) in children. BWS is a growth disorder that can cause large body size, large organs, and other health problems in babies. Researchers have found that changes in genes related to the subcortical maternal complex (SCMC) might play a role not only in BWS but also in women who face challenges with pregnancy.

    The main goals of this research are to find out how common these genetic changes are in women who have trouble getting pregnant or who have children with BWS, to look for patterns in DNA methylation (a process that affects how genes work) in these women, and to study these effects in a mouse model to better understand the underlying causes of infertility and BWS.

    Participants in the study will be divided into three groups: healthy women with BWS children and a unique reproductive history, women under 35 undergoing assisted reproductive technology (ART) treatments without success, and women under 35 with recurrent pregnancy loss. The study will use whole-exome sequencing (WES) to look for genetic changes and whole-genome methylation analysis to study DNA methylation patterns. Some participants, especially those with BWS children and no identified genetic changes from WES, will also undergo whole-genome sequencing (WGS) to explore more areas of their DNA.

    By joining this study, participants will contribute to a deeper understanding of how genetic variations and epigenetic changes can impact reproductive health and the development of conditions like BWS. This research could lead to better diagnosis, treatment, and support for women facing these challenges.

  • Exploring New Treatments for Brain Tumors Targeting Cancer Stem Cells

    This clinical trial focuses on developing new treatments for brain tumors, specifically targeting a type of cell called cancer stem cells (CSCs) that play a crucial role in the aggressiveness and resistance to current treatments of these tumors. Brain tumors, such as Glioblastoma (GBM), are among the most aggressive and have a low survival rate, making the need for new therapeutic approaches urgent.

    The study is particularly interested in how a lipid called Sphingosine-1-phosphate (S1P) influences these cancer stem cells. S1P is involved in the tumor’s ability to grow, resist drugs, and spread, making it a potential target for new treatments. By understanding how the environment around the tumor affects these cells and their metabolism, especially under low oxygen conditions (hypoxia), researchers hope to find new ways to stop the tumor from growing and resisting treatment.

    The main goal of this project is to identify new molecular and metabolic targets that are crucial for the survival and resistance to chemotherapy of tumor stem cells. This could lead to the development of new drugs that can inhibit the proliferation of CSCs and, consequently, tumor progression.

    For patients participating in this study, researchers will be investigating specific markers related to the development and progression of brain tumors to improve diagnosis, treatment, and monitoring. This research could significantly improve the prognosis for patients suffering from brain tumors by identifying new therapeutic strategies and potential biomarkers.

  • 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
  • Testing the effectiveness of new drugs in the treatment of age-related macular degeneration

    The study is investigating a potential breakthrough in treating age-related vision loss, specifically neovascular age-related macular degeneration (nAMD). It introduces a novel therapy, OPT-302, and pairs it with Aflibercept, comparing this combination’s effectiveness against the standard treatment. Participants undergo a series of thorough eye examinations and treatments to monitor the progression of their vision health. The research aims to offer a clearer understanding of how these treatments can better manage and possibly improve vision for individuals dealing with nAMD, contributing valuable knowledge to the field of eye health care.

    • aflibercept
    • OPT-302

See more clinical trials in other cities in Italy:

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