Clinical trials located in

Roma

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

  • 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 comparing Giredestrant and Fulvestrant with CDK4/6 Inhibitors for advanced breast cancer

    This study focuses on a type of advanced breast cancer known as Estrogen Receptor-Positive (ER+), HER2-Negative breast cancer. This kind of cancer is driven by hormones and does not have high levels of the HER2 protein. The study aims to evaluate the effectiveness and safety of a new drug called Giredestrant compared to an existing drug called Fulvestrant. Both drugs will be combined with one of three medicines that inhibit proteins in cancer cells called CDK4/6 inhibitors (Palbociclib, Ribociclib, or Abemaciclib).

    In this study, participants will be randomly assigned to one of two groups. One group will receive Giredestrant and the other will receive Fulvestrant. Both groups will also receive one of the CDK4/6 inhibitors chosen by their doctor. These combinations are being tested to see which works better to stop the cancer from growing or spreading.

    The drugs involved include Giredestrant (RO7197597, RG6171, GDC-9545), Fulvestrant, Abemaciclib, Palbociclib, Ribociclib, and LHRH Agonist (for pre/perimenopausal women and men).

    The goal is to find out if Giredestrant can provide better results and fewer side effects compared to Fulvestrant when both are combined with one of the CDK4/6 inhibitors. The study may involve regular tests and assessments to monitor the cancer’s progress and the patient’s response to the treatment.

    Participants will continue to receive the study drugs as long as they are benefiting from them and not experiencing unacceptable side effects. The study involves close monitoring to ensure the safety and well-being of all participants throughout the treatment period.

    • LHRH Agonist
    • Abemaciclib
    • Giredestrant
    • Palbociclib
    • Ribociclib
    • Fulvestrant
  • Study of Palazestrant or standard therapy in advanced ER+/HER2- breast cancer

    This clinical trial is for patients with advanced or metastatic breast cancer with hyperactivity of estrogen receptors (ER+) and no hyperactivity of HER2- receptors (advanced HER2- breast cancer). The therapy used in the study includes a new drug called palazestrant (OP-1250) and other standard endocrine therapies such as Fulvestrant or aromatase inhibitors (anastrozole, letrozole, exemestane).

    The aim of the study is to compare the effectiveness and safety of palazestrant (OP-1250) as monotherapy compared to the above-mentioned standard therapies in the treatment of this type of breast cancer.

    Patients in the study will be randomly assigned to one of the groups – one receiving palazestrant (OP-1250) and the other receiving one of the standard therapies (fulvestrant, anastrozole, letrozole or exemestane). The study will assess progression-free survival (the time from the start of treatment to the time the disease starts to progress again) and overall survival of participants (the time from the start of treatment to death from any cause).

    • Palazestrant
    • Fulvestrant
    • Anastrozole
    • Letrozole
    • Exemestane
  • 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 of INBRX-109 for patients with unresectable or metastatic conventional chondrosarcoma

    Conventional chondrosarcoma is a type of cancer that affects the bones. This clinical trial focuses on evaluating a new treatment for patients with unresectable (inoperable) or metastatic (spread to other parts of the body) conventional chondrosarcoma. The therapy being tested is called INBRX-109. INBRX-109 is an experimental drug, specifically a humanized antibody that targets a protein called death receptor 5 (DR5). The study aims to determine whether INBRX-109 can help patients who have this type of bone cancer.

    In this study, participants will be randomly assigned to one of two groups: one group will receive INBRX-109, and the other will receive a placebo. Neither the participants nor the researchers will know who is receiving the actual drug and who is receiving the placebo. This is known as a double-blind study. Participants will receive their assigned treatment through an intravenous infusion every three weeks. If the disease progresses, those in the placebo group will be allowed to switch to the INBRX-109 treatment.

    The primary goal of the study is to see how well INBRX-109 works in preventing the cancer from getting worse. The study will also look at overall survival rates, how long any responses to the treatment last, and the quality of life of the participants during the study. Safety and tolerability of INBRX-109 will also be evaluated by monitoring for any side effects. Participants will have regular visits and tests to check on their condition and the effects of the treatment. This clinical trial offers a potential new treatment option for patients with difficult-to-treat chondrosarcoma, aiming to improve their outcomes and quality of life.

    • INBRX-109
    • placebo
  • A study of dupilumab in the treatment of Eosinophilic gastroenteritis in adults and adolescents

    The study involves a drug called Dupilumab and targets adults and adolescents with active eosinophilic gastroenteritis. This is a rare chronic immune disease in which eosinophils (a type of white blood cell) accumulate in large numbers in the stomach and small intestine, causing inflammation and damage. The aim of the study is to evaluate the effect of dupilumab on relieving symptoms of the disease and reducing inflammation in the stomach and small intestine in adults and adolescents.

    The study consists of three parts, plus a screening and observation part. In Parts A and B, participants will be randomly assigned to a group receiving dupilumab or placebo for 24 weeks in a double-blind (neither participants, physicians nor study staff will know which treatment a participant is receiving). Part C is a 28-week extension part, in which all participants from parts A and B will receive dupilumab.

    • Placebo
    • Dupilumab
  • 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
  • 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
  • Study on Alogabat for Children and Teens with Angelman Syndrome

    This study is investigating a medication called Alogabat for children and adolescents aged 5-17 years who have Angelman Syndrome with a specific genetic deletion. The research will explore how different doses of Alogabat affect the body by measuring its concentration over time and observing any changes in brain activity and safety outcomes. The study includes several phases where doses are adjusted based on early results. This research aims to determine Alogabat’s effectiveness in treating symptoms of Angelman Syndrome in younger populations.

    • Alogabat
  • Study of sarilumab in the treatment of juvenile idiopathic arthritis in children and adolescents

    This is a trial that aims to find the right dose of a drug called sarilumab for treating children and teenagers aged 1 to 17 years old with Systemic Juvenile Idiopathic Arthritis. Sarilumab is given as an injection under the skin. The main goal is to understand how the body processes this drug in young patients, so they can receive an adequate dose for treating their condition.

    The study will last for about 166 weeks, which is a little over 3 years. It starts with a 4-week screening period, followed by a 12-week treatment phase where the patients will receive repeated doses of sarilumab. After that, there is a 144-week extension phase where the patients can continue receiving the drug, and finally a 6-week follow-up period.

    During the first 12 weeks, the researchers will closely monitor the levels of sarilumab in the patients’ blood to understand how their bodies handle the drug. They will look at the maximum concentration reached, the total amount of drug exposure over time, and the levels just before each new dose. This information will help them determine the right dose and dosing schedule for children and adolescents with Systemic Juvenile Idiopathic Arthritis.

    In addition to studying the drug levels, the researchers will also evaluate the effectiveness of sarilumab in reducing the symptoms of this condition and monitor any potential side effects to ensure the drug is safe for long-term use in this age group.

    • Sarilumab
  • Clinical Trial for Finding the Best Dose of Clodronate for Painful Knee Osteoarthritis

    Howdy there, folks! This here clinical trial is aimin’ to find the best dose of a medicine called clodronate for treatin’ painful knee arthritis. It’s gonna be split into two parts.

    In the first part, they’ll have four groups of folks with knee arthritis. Three of them groups will get different doses of clodronate injected right into their knee once a week for four weeks. The fourth group will get a placebo, which is like a fake medicine. They’ll be keepin’ an eye on how safe and tolerable them different doses are.

    Once they figure out which dose works best without too many side effects, they’ll move on to the second part. In that part, they’ll have two groups – one gettin’ the best dose of clodronate from the first part, and the other gettin’ a placebo again. They’ll be checkin’ to see how effective and safe that best dose really is for helpin’ with knee arthritis pain.

    The main thing they’re lookin’ for is if the clodronate can reduce knee pain by at least 10 millimeters on a special pain scale called the Visual Analogue Scale, compared to the placebo group. They’ll be measurin’ that around 7 weeks into the study.

    So in a nutshell, they’re tryin’ to find the best and safest dose of clodronate for helpin’ folks with painful knee arthritis. It’s a two-part study, and they’ll be keepin’ a close eye on how well it works and how well it’s tolerated.

    • Clodronate
    • placebo
  • A study comparing biosimilar nivolumab and nivolumab in the treatment of resected melanoma

    The aim of this study is to test whether a new drug called ABP 206 (biosimilar nivolumab) works as well as the approved cancer drug OPDIVO® (nivolumab) in people with advanced cutaneous melanoma that has been surgically removed. The study divided people into 3 groups: one group will receive ABP 206, the second will receive real OPDIVO® approved in the US, and the third will receive the version of OPDIVO® approved in Europe. All of these medicines will be given through an intravenous drip every 4 weeks for up to 1 year, or until the cancer comes back or gets significantly worse.

    The main goal is to check whether ABP 206 (biosimilar nivolumab) is absorbed and maintained in the body in the same way as OPDIVO®. Researchers will also closely monitor how well it works, what the side effects are, and whether the body produces antibodies against it. The entire study will last approximately 13 months for each person joining.

    • Nivolumab biosimilar
    • Nivolumab
  • Study of DYP688 in patients with metastatic uveal melanoma

    The aim of this study is to test a new drug combination to treat metastatic uveal melanoma, a type of cancer that starts in the eye and spreads to other parts of the body. The main drugs being tested are IDE196 (also called darovasertib) and crizotinib, both taken by mouth twice daily.

    Currently, this process is divided into several stages. In the first part, investigators will test two different doses of IDE196 in combination with crizotinib and compare them to other approved therapies such as pembrolizumab, ipilimumab + nivolumab, or dacarbazine. Once they determine the best dose of IDE196, they will move to the next step in which everyone will receive that dose along with crizotinib or one of the other treatments.

    Researchers will primarily look at how long the cancer stays under control without getting worse and how long patients live. It could take about 4 years to get all the answers you need.

    • Darovasertib/IDE196
    • Dacarbazine
    • Nivolumab
    • Crizotinib
    • Ipilimumab
    • Pembrolizumab
  • 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
  • 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
  • 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
  • Evaluating Ianalumab for active Sjogren’s syndrome

    The NEPTUNUS-2 study is a significant research project aimed at exploring the effectiveness and safety of a medication called ianalumab (VAY736) for individuals suffering from active Sjogren’s Syndrome. This study is designed as a three-arm, randomized, double-blind, placebo-controlled trial, which means participants will be randomly assigned to one of three groups: two will receive ianalumab at different intervals, and one will receive a placebo, with neither the participants nor the researchers knowing which group participants are in to ensure unbiased results.

    The main goal of this study is to determine how well ianalumab can improve the symptoms of Sjogren’s Syndrome compared to a placebo. This will be measured by the change in a specific score called the EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) from the start of the study to week 48. The ESSDAI score helps doctors understand how active the disease is, with a higher score indicating more active disease. A decrease in this score over time would suggest an improvement in the condition.

    Participants in this study will receive ianalumab injections either once a month or every three months, depending on the group they are assigned to. The study emphasizes not only the potential benefits of ianalumab in treating Sjogren’s Syndrome but also its safety and tolerability, ensuring that the treatment is not only effective but also safe for patients.

  • Comparison of zibotentan/dapagliflozin with dapagliflozin alone in the treatment of chronic kidney disease with high proteinuria

    The study aims to understand how to better treat people with chronic kidney disease (CKD) and high proteinuria. This study is in its third phase and involves multiple centers where participants will be closely monitored. The main goal is to compare the effectiveness, safety, and how well participants tolerate a combination treatment of zibotentan/dapagliflozin versus dapagliflozin alone.

    During this study, participants will be randomly assigned to one of two groups. One group will receive the combination of zibotentan and dapagliflozin, while the other group will receive only dapagliflozin. Both treatments aim to slow down the decline in kidney function, which is a major concern for people with CKD and high proteinuria. The key measure of success for this study is the change in eGFR from baseline, which is a test used to check how well the kidneys are working, specifically by measuring the estimated glomerular filtration rate (eGFR). This will be assessed at the 24-month mark of the study.

    This research is crucial because it could lead to better treatment options for those suffering from CKD and high proteinuria, potentially improving their quality of life and health outcomes.

    • Zibotentan/Dapagliflozin
    • Dapagliflozin
  • Exploring encaleret’s effectiveness for Autosomal Dominant Hypocalcemia type 1

    This clinical study is a research project focused on understanding how well and safely a medication called Encaleret works compared to the usual treatments for a condition known as Autosomal Dominant Hypocalcemia Type 1 (ADH1). ADH1 is a rare genetic condition that can lead to low calcium levels in the blood and is often inherited from parents to their children.

    The study is designed to last about 12 months, with an additional option to continue in a longer-term extension for up to 48 months or more, depending on certain conditions. Initially, participants will go through a screening phase to make sure they meet the study requirements.

    Participants will then enter a period where their usual care treatment is maintained, with adjustments only made for safety reasons. Following this, they will be randomly assigned to either continue with their standard care or start taking encaleret. This part of the study allows both the doctors and participants to know which treatment is being used and to adjust the dosage based on blood calcium levels. After 20 weeks, there’s a period to maintain the dose before possibly moving on to the long-term extension phase, where encaleret will be continued.

    The main goal of the study is to see how many participants can reach and maintain their blood and urinary calcium levels within a target range by using encaleret compared to their standard treatments. This is important for managing the symptoms and health risks associated with ADH1.

    This study might be an opportunity for people with ADH1 to try a new treatment option and contribute to research that could help others with the same condition in the future.

    • Encaleret

See more clinical trials in other cities in Italy:

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