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Clinical trials located in

Sofia

Sofia city is located in Bulgaria. Currently, 20 clinical trials are being conducted in this city.

Sofia, the capital of Bulgaria, nestles in the Sofia Valley at the foot of the Vitosha Mountain. Established thousands of years ago, Sofia is among Europe’s oldest cities, boasting a rich mosaic of history and culture. Its streets are a testament to its layered past, with Roman ruins sitting alongside Ottoman mosques and Soviet-era monuments. The city is also home to the stunning Alexander Nevsky Cathedral, one of the largest Eastern Orthodox cathedrals in the world. Sofia’s thermal springs, known since antiquity, continue to be a natural treasure.

  • CT-EU-00111952

    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.

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  • Exploring the Impact of ATL1102 in Boys with Duchenne Muscular Dystrophy

    This study is designed to test the effectiveness and safety of a new treatment called ATL1102. The trial is specifically for boys aged 10 to <18 who cannot walk (non-ambulatory).

    The study is divided into two main parts. In the first part, participants will be randomly assigned to receive either ATL1102 at doses of 25 mg or 50 mg, or a placebo (a treatment with no active drug), given as a weekly subcutaneous injection. This phase will last for 24 weeks and is double-blind, meaning neither the participants nor the researchers will know who is receiving the actual drug or the placebo.

    Following this, all participants will move into the second part of the study, where they will receive ATL1102 for another 24 weeks. This part is open-label, which means everyone will know they are receiving the active drug.

    The main goal of the study is to see how well ATL1102 can improve upper limb strength, which is crucial for daily activities. This will be measured using the Performance of Upper Limb (PUL) 2.0 score, a tool designed to assess upper limb strength in individuals with DMD.

    BulgariaUnited Kingdom
  • 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.

    BulgariaRomania
  • 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.

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  • Study on new combination therapy for aggressive lymphoma

    This study is about a less common but severe form of cancer known as Diffuse Large B-Cell Lymphoma (DLBCL). It is testing if a new medication called epcoritamab, given with a mix of other commonly used cancer medicines, can help control the disease better. These other medicines include rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone, which are often collectively referred to as R-CHOP. The study includes about 900 adults from around the world who have recently been diagnosed with this type of lymphoma. They will be split into two groups. One group will get epcoritamab with R-CHOP and then continue with epcoritamab. The other group will get R-CHOP followed by rituximab. Doctors will carefully watch for changes in the disease and for any side effects. There will be many checks on health, including medical exams, blood tests, questionnaires, and monitoring of any side effects.

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  • Study of the effectiveness of tanimilast in the treatment of pulmonary diseases

    A 52-week clinical trial is being conducted to investigate the effectiveness and safety of the new drug, known as Tanimilast (CHF6001), in people diagnosed with chronic bronchitis and chronic obstructive pulmonary disease (COPD). The primary aim of the study is to determine the effectiveness of CHF6001 administered as an addition to a standard COPD treatment regimen. Study participants will be randomly assigned to receive the study drug CHF6001 or a placebo, which will be taken concurrently with their existing COPD therapy. Key measurements in the study include monitoring the frequency and severity of COPD exacerbations, which are episodes of significantly worsening symptoms. Additionally, the study will assess changes in participants’ lung function and overall quality of life. Typically eligible for the study are adults who are 40 years of age or older, have a documented history of COPD and chronic bronchitis, and are current or former smokers. In particular, the study is of interest to people who have experienced at least one COPD exacerbation in the year preceding the study.

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  • Testing new medicine for resistant high blood pressure

    In this 20-week trial, the effectiveness, safety, and optimal dosage of a medication known as XXB750 are being evaluated in individuals with resistant high blood pressure (resistant hypertension). This condition persists despite the use of three different blood pressure medications. XXB750 will be administered through subcutaneous injections, and its efficacy will be compared to a placebo. A 2-week preparation period precedes the trial, during which participants receive three doses of the actual trial medicine and one dose as part of the preparation. Following the trial, participants will be monitored for an additional 8 weeks without receiving any trial medicine during this period. The primary focus is on assessing whether XXB750 can effectively reduce blood pressure when measured over a 24-hour period.

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  • Comparing sotorasib and pembrolizumab in treating advanced nonsquamous non-small cell lung cancer

    This trial is testing two first-line therapies in people with advanced lung cancer. Two drugs, Sotorasib and Pembrolizumab, are compared, each combined with a special type of chemotherapy known as a “platinum doublet.” The goal is to determine which combination of these two treatments works most effectively in slowing the growth of the cancer or extending the patient’s life. Patients are selected based on the type and stage of lung cancer. The trial is considered appropriate for people with advanced stage IIIB, IIIC or IV non-squamous non-small cell lung cancer. Additionally, the test is intended for people whose cancer cells show a specific response, including no response to PD-L1, but a positive response to KRAS p. G12C.

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  • Research on new medicine for advanced or metastatic lung cancer

    This study investigates a new medicine called JDQ443’s ability to combat advanced non-small cell lung cancer. It involves two groups based on their PD-L1 levels and mutations KRAS G12C. The study has two parts (called cohorts), each involving different people. The study is carried out in stages called ‘cycles’ which last for 21 days each. During the study, assessments will be conducted to evaluate the medicine’s effectiveness, and health monitoring will be implemented. This involves measuring factors such as the duration until disease progression and the length of survival post-treatment initiation.

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  • 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.

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  • Testing safety and effects of telisotuzumab and docetaxel in Lung Cancer patients

    This study is for adults who have been treated before for a type of lung cancer called non-small cell lung cancer (NSCLC). The aim is to see if a new drug, called telisotuzumab vedotin, works better and is as safe as a common drug called docetaxel. In this study, cancer activity and any side-effects will be observed closely. The treatment will be given by a drip into a vein.The researchers will randomly decide whether each participant will get telisotuzumab vedotin or docetaxel, with an equal chance of getting either drug. While in the study, each person will have regular hospital or clinic visits to check how they are doing with tests and questionnaires.

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  • Macitentan and selexipag in ongoing pulmonary hypertension care

    This study is for people with a lung disease called pulmonary hypertension (PH) who have taken part in a previous study and are receiving specific treatment. The main goal of the study is to enable these people to continue treatment even after the previous study has ended. The study involves monotherapy with Macitentan or Selexipag and a combination of Macitentan and Tadalafil at fixed doses. All of these drugs are administered orally. The aim of the study is to check how safe the treatment is when used long-term. Will be monitored if any adverse events occur. If this leads to discontinuation of treatment, this will be reported.

    BelgiumBulgariaPoland
  • Evaluating the efficacy of macitentan in the treatment of high pulmonary artery blood pressure

    This study is checking if a 75 mg dose of a medicine called Macitentan can do a better job for patients with a lung condition called Pulmonary Arterial Hypertension (PAH) compared to a 10 mg dose. The main goal is to see if the 75 mg dose can better delay the patient’s first major health event related to PAH. Major events include things like unplanned hospital stays related to PAH, or their PAH getting worse. The researchers will check if patients’ PAH gets worse by looking at things like their physical exercise ability and signs of heart failure. The study also looks at how patients’ symptoms change from day to day.

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  • Examining mometasone furoate role in treating long-lasting sinusitis

    This trial will study the effects of a drug called LYR-210 (Mometasone Furoate) on adults who have a long-term nose and sinus condition known as chronic rhinosinusitis (CRS). It focuses on the treatment’s effectiveness and safety over 24 weeks, comparing LYR-210 with a sham procedure. The study measures symptom changes, assessing impacts on nasal blockage, discharge, and facial pain. The trial is a significant step towards potentially offering relief to those suffering from persistent sinus challenges.

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  • Study on Aticaprant’s safety and effects as an adjunctive therapy for major depressive disorder

    This trial is for adults and elders who are struggling with major depressive disorder (MDD). The trial involves a medicine called aticaprant, and this is supposed to be taken alongside what they are already using to handle their depression (SSRI or SNRI drugs). The study aims to determine the long-term safety and efficacy of aticaprant. To achieve this, close monitoring of adverse events, which includes negative reactions or changes in patients’ health, is crucial. Physical health indicators, such as weight, core body temperature, heart rate, and blood pressure, will be assessed to understand the potential impact of aticaprant. Additionally, the study will evaluate patients’ thoughts on suicide, any discernible changes in their sexual health, and their overall mood.

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  • Study of alpelisib and fulvestrant for advanced breast cancer treatment

    This trial is looking at the effects of the combined use of two drugs, alpelisib and fulvestrant, in treating patients who have advanced breast cancer. The cancer should be HR-positive and HER2-negative, and have a specific mutation (PIK3CA). If the patients already underwent certain other treatments like CDK4/6 Inhibitors and aromatase Inhibitors, but the cancer has progressed, they could join this trial. Doctors will be able to compare the results of patients taking alpelisib and fulvestrant together, with those taking fulvestrant with a placebo, They aim to check which combination works better in delaying the advance of cancer or in improving a patient’s life duration.

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  • Long-term study on donidalorsen in hereditary angioedema

    This is a research assessing the long-term safety and effectiveness of donidalorsen in the prophylactic treatment of hereditary angioedema (HAE-1 and HAE-2). The study includes two groups of participants: 1) individuals transitioning from another study with donidalorsen, and 2) new participants not transitioning from another donidalorsen study, who were previously on prophylactic therapy with lanadelumab, berotralstat, or a C1-esterase inhibitor (C1-INH). The duration of participation in the study is 70 or 76 weeks.

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  • Examining new medicine safety for schizophrenia in adults

    The study in question is centered around the evaluation of a medication called CVL-231, also recognized as Emraclidine. The aim is to provide assistance to adults contending with the health condition known as Schizophrenia, which impacts cognitive and emotional aspects. The primary objective is to ascertain the safety of Emraclidine over an extended period, specifically for a duration of one year. The observation will encompass the identification of any potential side effects and an assessment of the overall well-being of individuals as they undergo daily administration of the medication.

    Bulgaria
  • CT-EU-00076276

    Comparing biosimilar denosumab and Prolia® in healthy men

    This research is a comparison test between a drug called ‘Biosimilar Denosumab’ and a drug called ‘Prolia’ (Denosumab). The goal is to test which one enters the body faster, lasts longer, and creates fewer side effects. Also, an important part is to see if they trigger any immune response. The drugs will be given to a group of healthy men in a single, small dose. Interestingly, this study has three competitors because it is comparing how Prolia from two different places (Europe and the US) performs alongside Biosimilar Denosumab.

    BulgariaPoland
  • 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.

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See more clinical trials in other cities in Bulgaria:

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