Clinical trials located in

Bucharest

Bucharest city is located in Romania. Currently, 20 clinical trials are being conducted in this city.

Bucharest, Romania’s vibrant capital, is steeped in history and culture. Known as the “Little Paris” in the early 20th century for its elegant architecture and the sophistication of its elite, the city boasts the colossal Palace of the Parliament, the world’s second-largest administrative building. Bucharest is also home to the oldest beer factory in Romania, established in 1869. The city’s rich cultural scene is reflected in its numerous museums, theaters, and the iconic Romanian Athenaeum, a symbol of Romanian culture. Despite its tumultuous history, Bucharest has emerged as a dynamic, bustling metropolis, blending its historical charm with modern vitality.

  • CT-EU-00120106

    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 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 Comparing Asciminib and Nilotinib for Newly Diagnosed Chronic Myeloid Leukemia

    This study examines the effects and tolerance of two drugs, asciminib and nilotinib, for treating a specific type of leukemia called Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in its chronic phase. The participants are adults who have been newly diagnosed and have not received previous treatment for this condition. They will be randomly assigned to receive either asciminib or nilotinib. The study aims to see which drug is better tolerated and how effective they are. Throughout the study, participants will be monitored for any side effects and the progress of their treatment until they either experience significant side effects, the disease progresses, or they decide to stop the treatment. Follow-up checks will also be conducted after the treatment ends.

    • Asciminib
    • Nilotinib
  • 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
  • Evaluating SPI-62 in treating ACTH-dependent Cushing’s Syndrome

    This is a study focused on a new treatment option for people suffering from ACTH-dependent Cushing’s syndrome, a condition often caused by a non-adrenal tumor. This condition leads to an overproduction of cortisol, which can have a significant impact on health. The study will test the efficacy and safety of a drug called SPI-62, which is designed to inhibit a specific enzyme involved in cortisol production.

    The study is structured as a randomized, placebo-controlled trial, meaning that participants will be randomly assigned to receive either SPI-62 or placebo treatment for a period of 24 weeks. Such a design helps ensure the reliability of the study’s results. Importantly, after this initial period, participants will have the option to continue the study and receive the active study drug, with follow-up visits every three months. The main goal of the study is to observe the change from baseline in urinary HSD-1 ratio, a marker that helps understand the activity of the enzyme targeted by SPI-62 in the liver. Participation in this study includes a screening period, a baseline period and a treatment period, with the possibility of a long-term extension for those who choose to continue.

    This trial represents a hopeful step forward for those affected by ACTH-dependent Cushing’s syndrome, offering a potential new treatment option that targets the condition at a molecular level.

    • SPI-62
  • SPI-62 as new drug for patients with ACTH-dependent Cushing’s syndrome

    This is a study focused on a new treatment option, SPI-62, for people struggling with ACTH-independent Cushing’s Syndrome. The main aim is to evaluate the efficacy and safety of SPI-62 in treating the condition.

    SPI-62 is a drug that works by inhibiting a specific enzyme in the body, potentially reducing excessive cortisol levels that contribute to the disease. During this study, participants will receive SPI-62 in oral tablet form. Dosing will vary, starting at a lower dose and potentially increasing depending on patient response and study requirements.

    The study has been designed as a Phase 2 trial, meaning that the primary focus is on understanding how well SPI-62 can treat the symptoms of hypercortisolism and what its safety profile is. Participants will be in the study for an extended period of time, with scheduled visits at baseline and then at 1, 3, 6, 9 and 12 months, followed by quarterly visits. These visits are crucial to monitor health status and treatment impact.

    One of the key aspects the researchers will be looking at is the change in HbA1c levels, a marker of blood sugar control, after both 6 and 12 weeks of treatment. This will help to understand whether SPI-62 can improve diabetes or the impaired glucose tolerance that often accompanies diabetes.

    • SPI-62- new potential medication for Cushing’s syndrome and Autonomous Cortisol Secretion
  • 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
  • A comprehensive evaluation of retatrutide in obesity and associated comorbidities

    This study evaluates the effectiveness and safety of a new drug, retatrutide, in individuals with obesity or overweight, including those with knee osteoarthritis or obstructive sleep apnea. Lasting about 89 weeks, the trial involves randomized assignment of participants to either receive retatrutide or a placebo. The main goals are to observe changes in body weight, knee pain in osteoarthritis, and sleep apnea severity. The study also examines various secondary outcomes like changes in BMI, waist circumference, and blood pressure. The trial aims to provide new insights into weight management and associated health conditions, offering hope for improved treatments.

    • Retatrutide
  • 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
  • Exploring the effects and safety of new therapy for Symptomatic Knee Osteoarthritis

    This study is a test of a medication called DFV890, focusing on its effectiveness, safety, and tolerance among individuals with arthritis in their knee, which causes significant pain. Some participants receive the actual medication, while others receive a ‘placebo’ with no active substance. Importantly, neither the participants nor their doctors are aware of which treatment they are receiving. The study duration is slightly over 5 months, and the primary objective is to assess whether DFV890 can help reduce knee pain.

    • DFV890- new potential medication for COVID-19 and knee osteoarthritis
  • Osimertinib effectiveness study for early-stage lung cancer post-surgery

    This study is examining the effects of osimertinib on patients with a specific type of early-stage lung cancer (EGFRm stage IA2-IA3 non-small cell lung cancer) after complete tumor removal surgery. It’s a Phase III trial comparing osimertinib, a new drug, with a placebo. Participants, who have already had surgery for their lung cancer, will either receive osimertinib or a placebo daily for three years. The goal is to see if osimertinib can prevent cancer from coming back and improve patients’ survival rates.

    • Osimertinib
  • Study of trastuzumab deruxtecan in gastric cancer or gastroesophageal junction adenocarcinoma

    The aim of the DESTINY-Gastric04 study is to help cancer patients suffering from certain diseases. These patients have a specific type of stomach cancer or adenocarcinoma of the gastroesophageal junction that has not responded to treatment or has gotten worse after treatment with a medicine called trastuzumab. This study is testing a new drug called trastuzumab deruxtecan, comparing it with a combination of two other drugs – ramucirumab and paclitaxel. A key goal of this study is to determine how long participants will live after starting a new treatment. It will also be observed whether the cancer will shrink or stop growing, how long it will last, what the potential side effects of treatment will be and how the body will respond to the new drug.

    • Ramucirumab
    • Trastuzumab deruxtecan
    • Paclitaxel
  • Study of the trial on weight loss and type 2 diabetes control of retatrutide

    This study involves a new drug called Retatrutide (LY3437943). It is intended for people who suffer from a type of sugar disease called type 2 diabetes and are also slightly or very overweight. This disease can lead to many health problems, so it is important to find good treatment. Scientists want to see if this new drug can help people with type 2 diabetes and who are overweight. They also wish to check whether it is safe for these people to take the drug. Some people in the study will have another health issue called obstructive sleep apnea, which occurs when a patient stops breathing for a short period of time while sleeping. Treatment lasts approximately 89 weeks and requires as many as 24 clinic visits. Scientists will measure the amount of the new drug in the bodies of people taking part in the study, and will also look at the drug’s effect on a range of health outcomes.

    • Retatrutide
  • Study on the safety and efficacy of a new medicine on various lupus types

    This study is for people with different types of lupus. The main reason for the study is to learn if a new drug named BMS-986326 is safe for people and how their bodies react to it. The study begins by administering small doses of the drug to participants. If these small doses are deemed safe, progressively larger doses are administered. This process is repeated until identifying the largest dose that remains safe and effective. The drug is administered to participants intravenous or via a subcutaneous injection. This is crucial as the goal is to determine the optimal administration method for this drug in people.

    • BMS-986326- new potential medication for autoimmune disorders and cancer
  • Testing brepocitinib medicine’s effect on adult skin and muscle disease

    This study is going to check if a medicine called brepocitinib can help adults with a skin and muscle disease called dermatomyositis. The researchers are making sure that patient results are accurate by giving some people the actual medicine and others a placebo, which has no active substance. The researchers are comparing two different amounts of the medicine against the placebo one to see if the patients get better. It will be tracked by creating a score based on how severe 6 different signs of the disease are, and then tallying up these scores over a period of one year. Those who are part of this one year study can choose to extend their participation for another year, where everyone gets the medicine with active substance. The researchers determine if the patient has improved by looking for an increase in their score of 40 points or more. And also look at how well a person can do their daily tasks, and also score the severity of any skin issues they have at the start and end of the study to check for changes.

    • Brepocitinib
  • Secukinumab study for maintaining remission in axial spondyloarthritis

    The aim of this study is to see if a drug called Secukinumab can maintain remission in people with non-radiographic axial spondyloarthritis (a type of spondylitis). Remission means that there is no or very little disease in the body. To determine whether a person is in remission, we use a special scoring system that looks at various symptoms of arthritis and a blood test for a protein associated with inflammation (C-reactive protein, or CRP). The aim of the study is to see whether people who stop taking Secukinumab will experience an exacerbation (worsening of the disease) and how long it takes for this to happen. The study will last just over two years.

    • Secukinumab
  • Continued study of ozanimod for severe Crohn’s Disease

    This research is about an extended study on the use of an oral medication named Ozanimod for people suffering from Crohn’s disease. Crohn’s disease can make the stomach and intestines really uncomfortable, causing swellings and pain. The main aim of this study is to check if this medicine, Ozanimod, is safe for intake and how effective it is in easing these uncomfortable feelings in the stomach. The researchers will rate patients’ illnesses using the Crohn’s Disease Activity Index (a measurement tool).

    • Ozanimod
  • Long-term study on the effectiveness of mirikizumab for Crohn’s Disease

    This research study is about a long-term test of a medicine called Mirikizumab for people who have Crohn’s disease. The main aim of this study is to know if the medicine is effective and safe for those people eventually. The effect of the medicine will be checked using different tests and scores like the Simple Endoscopic Score for Crohn’s Disease, the Crohn’s Disease Activity Index, and patient-reported outcomes. Researchers will also be checking changes in certain markers in the blood and stool that can show inflammation.

    • Mirikizumab
  • Studying ozanimod as ongoing treatment for Severe Crohn’s Disease

    This trial is to test a medication called Ozanimod on people who have a serious type of Crohn’s Disease. Crohn’s Disease can make the stomach hurt a lot and sometimes makes difficulty eating.  The researchers want to see if the medication helps to calm the disease, so patients feel better. Some patients will get the Ozanimod and others will get a placebo.  The researchers use  ‘Crohn’s Disease Activity Index’ to see how the disease is doing.

    • Ozanimod

See more clinical trials in other cities in Romania:

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