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-00121490

    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 a new drug for moderate to severe Rotator Cuff Tendinopathy

    The clinical trial examines the use of secukinumab, a drug, for treating moderate to severe rotator cuff tendinopathy—a shoulder condition characterized by pain and limited movement. The study explores whether secukinumab can improve symptoms and physical function compared to a placebo. Participants will receive either the drug or placebo in addition to standard care, under a randomized, double-blind, and placebo-controlled setup, to ensure the results are unbiased.

    • placebo
    • Secukinumab
  • Study of KRT-232 Combined with Ruxolitinib for Myelofibrosis Patients

    This here clinical trial is looking at a new drug called KRT-232 that’s taken by mouth. The study aims to see if combining KRT-232 with the existing drug ruxolitinib can help folks with myelofibrosis who ain’t responding well enough to just taking ruxolitinib alone.

    The main goal in the first part of the study is to find the right dose of KRT-232 to use when combined with ruxolitinib. They’ll be looking closely at any side effects to make sure the dose is safe. In the second part, they’ll check if the combination of the two drugs can shrink the size of the spleen by at least 35% after 6 months of treatment.

    • KRT-232
    • Ruxolitinib
  • 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 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
  • 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
  • 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 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.

    • ALT1102
  • 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
  • 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
  • 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.

    • Prednisone
    • Vincristine
    • Doxorubicin
    • Epcoritamab
    • Cyclophosphamide
    • Rituximab
  • 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.

    • Tanimilast/CHF6001
    • Roflumilast
  • 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.

    • XXB750
  • 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.

    • Sotorasib
    • Pembrolizumab
  • 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.

    • Opnurasib/JDQ-443
  • 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
  • Evaluation of Bemarituzumab in patients with solid tumors overexpressing the FGFR2b receptor

    The study concerns patients with solid tumors that are characterized by excessive expression of the FGFR2b receptor (Fibroblast Growth Factor Receptor 2b). In particular, this includes cancers such as head and neck squamous cell carcinoma, triple negative breast cancer, intrahepatic cholangiocarcinoma, lung adenocarcinoma, epithelial ovarian cancer, endometrial adenocarcinoma and cervical cancer. The therapy that will be used in this study is bemarituzumab (also known as AMG 552), administered by intravenous infusion.

    The aim of the study is to assess the safety and tolerability of bemarituzumab and its preliminary anticancer effectiveness. Patients with the above cancers whose disease recurs or does not respond to standard therapies may be eligible to participate in the study.

    Patients must have confirmed recurrent or refractory cancer that is not suitable for surgical treatment. An additional condition is excessive expression of the FGFR2b receptor in their tumor. The experimental therapy includes two phases: in the first phase, determining the optimal dose, and in the second, expanding the therapy to a larger group of patients using a previously determined dose.

    • Bemarituzumab
  • 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.

    • Telisotuzumab Vedotin
    • Docetaxel
  • 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.

    • Selexipag
    • Macitentan/Tadalafil FDC
    • macitentan

See more clinical trials in other cities in Bulgaria:

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