Clinical trials located in Europe

Select your disease:

  • CT-EU-00121077

    Study on the effectiveness and safety of DMX-200 for FSGS patients using ARB

    Focal Segmental Glomerulosclerosis (FSGS) is a rare kidney disease where some parts of the kidneys become scarred, leading to kidney damage and protein loss in urine. This study involves a therapy using an experimental drug named DMX-200 (also known as repagermanium), which, when taken with a type of medication called an Angiotensin II Receptor Blocker (ARB), aims to halt the inflammation that contributes to chronic kidney disease.

    The study is designed to assess how well DMX-200 works and how safe it is in treating people with FSGS. It will compare the effects of DMX-200 with a placebo over a period of 104 weeks (about 2 years). Patients will be given either DMX-200 in capsule form to take twice daily or a placebo. Given the rarity of FSGS, the study will include both adults and adolescents aged 12 to 17 years.

    The study will start with a screening period to ensure all necessary assessments are completed. This will be followed by the main treatment phase, lasting 104 weeks. After this, there will be a 4-week follow-up period without treatment to observe any changes. Patients who complete this double-blind period and might benefit from continued treatment will enter an open-label extension phase. During this phase, participants will receive DMX-200 for an additional 2 years, also followed by a 4-week off-treatment period for further observation.

    The goal is to determine the effectiveness and long-term safety of DMX-200 for treating FSGS. The study aims to improve understanding and develop new treatments for this challenging kidney condition.

    • DMX-200
    • placebo
  • Testing BI 764198 for Kidney Disease (FSGS): A 4-Month Study

    This study is focused on individuals with a kind of kidney disease called Focal Segmental Glomerulosclerosis (FSGS). The purpose is to see if a drug named BI 764198 can improve kidney health for people with FSGS. There will be three different doses of BI 764198 tested in the study.

    Participants in the study will be divided into four groups randomly. Three groups will receive different doses of BI 764198, and one group will receive a placebo. The study will last about four months. For approximately three months, participants will take a BI 764198 capsule or placebo capsule daily.

    Participants will visit the study site around ten times. It is possible to participate from home, in which case a research nurse will visit for the study visits. Kidney health will be checked by analyzing urine samples that participants collect at home. The results will be compared between the different groups at the end of the study. Throughout the study, doctors will also regularly monitor the general health of participants.

    • BI 764198
    • placebo
  • Study of WAL0921 for Treating Glomerular Kidney Diseases

    WAL0921 is a treatment being investigated for several types of glomerular kidney diseases that cause damage to the kidney’s filtering units. These diseases include diabetic nephropathy, primary focal segmental glomerulosclerosis (FSGS), treatment-resistant minimal change disease (TR MCD), primary immunoglobulin A nephropathy (IgAN), and primary membranous nephropathy (PMN). These conditions often lead to proteinuria, which is an abnormal amount of protein in the urine.

    The study aims to assess the safety and effectiveness of WAL0921. Participants will either receive WAL0921 or an inactive treatment designed to look like the real drug (placebo), given through an intravenous infusion once every two weeks for a total of 7 infusions.

    The primary goal is to monitor any side effects and how the drug acts in the body during and after treatment. All participants will be observed for 24 weeks after their last infusion to gather comprehensive data on the treatment’s impact.

    • WAL0921
    • placebo
  • Studying the safety of a new medicine in treating Primary biliary cholangitis (PBC)

    The study is aimed at patients suffering from primary biliary cholangitis (PBC), a disease causing inflammation and narrowing of the bile ducts. The therapy involves the administration of the drug A3907, also known as Ritivixibat.

    The main goal of the study is to evaluate how safe and well-tolerated A3907 is in individuals with PBC. Additionally, doctors will examine how participants’ bodies respond to the drug and what changes occur during treatment.

    Adults aged 18 to 75 with clinical symptoms of PBC for at least six months can participate. The study includes various dosing groups of A3907 to understand which dose is most effective and safe.

    An important aspect of the study is that participants must be clinically stable for at least three months prior to its commencement. Women of childbearing age must use appropriate contraceptive methods, and all participants must be willing to sign informed consent.

    The study does not include individuals with other chronic liver diseases, including cirrhosis, or those who have had liver transplants or other internal organ surgeries in the past.

  • Study on the use of Volixibat for the treatment of pruritus in patients with primary cholangitis (PBC)

    The purpose of this clinical trial is to evaluate the efficacy and safety of an investigational drug called volixibat in patients with pruritus caused by primary cholangitis. The study aims to understand how volixibat affects the treatment of pruritus associated with this disease and to evaluate its possible effect on disease progression.

    Study participants will be randomly assigned to a group receiving volixibat or placebo. Volixibat will be administered as oral capsules twice daily. The main goal of the study is to measure the average change in daily pruritus scores using a special Adult Itch Reported Outcome (Adult ItchRO) questionnaire. Adult ItchRO is an 11-point scale for assessing pruritus severity, where 0 means no pruritus and 10 means the worst possible pruritus. The study will run from baseline to week 28.

    • Volixibat
    • 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 of the drug EP-104IAR in adults with eosinophilic esophagitis

    The clinical trial concerns patients with eosinophilic esophagitis (EoE) who will be treated with EP-104IAR. EP-104IAR is a long-acting fluticasone-based drug intended for administration by submucosal injection during an endoscopic procedure of the esophagus, stomach and duodenum (EGD).

    The aim of the study is to assess safety, tolerance and the way the body absorbs and eliminates the drug (pharmacokinetics). The study will also evaluate the local effect of the drug on eosinophilic esophagitis disease activity based on endoscopic and histological (tissue) tests.

    The study will involve up to 24 adult participants aged 18 to 75. Participants will be divided into different groups and will receive different doses of EP-104IAR (from 4 mg to 40 mg).

    Individuals participating in the study should have symptoms of eosinophilic esophagitis and must be able to follow study procedures and visit schedules. Participants should not have other esophageal diseases or mucosal infections.

    It is aimed at patients who are ready and able to provide informed consent to participate in the study. During the study, doctors will monitor the patients’ health and carefully assess the effects of the therapy.

    • EP-104IAR
  • Study of Barzolvolimab (CDX-0159) in Adult Patients with Eosinophilic Esophagitis

    This clinical study involves patients with Eosinophilic Esophagitis (EoE), a condition where a type of white blood cell, called eosinophils, builds up in the lining of the esophagus. This can lead to difficulty swallowing and other issues. The therapy being tested is barzolvolimab (CDX-0159).

    The goal of the study is to test the effectiveness and safety of barzolvolimab in adults with active EoE. There are two main groups in this study: one will receive barzolvolimab, and the other will receive a placebo, followed by barzolvolimab.

    Participants will receive treatment through subcutaneous (under the skin) injections every four weeks for 24 weeks. In the barzolvolimab group, patients will get 300 mg of the medication from the start. In the other group, patients will receive a placebo for the first 16 weeks and then switch to barzolvolimab for the remaining 8 weeks.

    The study will look at changes in the number of eosinophils and other cells in the esophagus, as well as symptoms like difficulty swallowing. Side effects and other health changes will be monitored throughout the study.

    • Placebo
    • barzolvolimab
  • Testing Tislelizumab and Spartalizumab for Various Cancers with High PD1 Levels

    This study focuses on the treatment of various types of cancer, including colorectal cancer, melanoma, anal carcinoma, mesothelioma, triple-negative breast cancer, lung adenocarcinoma, cholangiocarcinoma, cervical carcinoma, kidney clear cell carcinoma, stomach adenocarcinoma, esophageal adenocarcinoma, uterine adenocarcinoma, head and neck squamous cell carcinoma, sarcoma, lung squamous cell carcinoma, urothelial carcinoma, thyroid carcinoma, hepatocellular carcinoma, uveal melanoma, HER2-positive breast cancer, pancreatic adenocarcinoma, squamous esophageal carcinoma, epithelial ovarian cancer, uterine carcinosarcoma, small cell lung cancer, hormone receptor positive/HER2-negative breast cancer, lung adenocarcinoma with EGFR mutation or ALK translocation, colorectal adenocarcinoma, prostate adenocarcinoma, carcinoma of unknown primary, and other histologies.

    The therapy involves two drugs: Spartalizumab and Tislelizumab. Spartalizumab is administered at a dose of 400 mg intravenously every 28 days, while Tislelizumab is administered at a dose of 300mg intravenously every 28 days.

    The purpose of this study is to evaluate the effectiveness of these drugs in patients with tumors that express high levels of a protein called PD1 or lower levels in which PD1/PD-L1 inhibitors have been previously established to be effective. PD1 is a protein found on the surface of cells that helps keep the body’s immune responses in check and blocks cancer-fighting immune cells.

    The study is divided into three groups, called cohorts. Patients will first sign a consent form to allow a molecular test to determine the PD1 levels of their tumor. Patients with high PD1-expressing tumors will be placed into cohort 1 or cohort 3. Those with low PD1-expressing tumors, where the effectiveness of similar treatments has been previously established, will be placed into cohort 2.

    – Cohort 1 will receive Spartalizumab as monotherapy (single drug treatment).
    – Cohort 2, consisting of patients with PD1-low tumors, will also receive Spartalizumab as monotherapy.
    – Cohort 3 will receive Tislelizumab as monotherapy.

    Frequent evaluations will be conducted to monitor the patient’s response to the treatment. Participants will receive the drugs intravenously (through a vein) every 28 days and will be closely observed for any improvements or potential side effects.

    • Spartalizumab
    • Tislelizumab
  • Study of KFA115 alone and with pembrolizumab for Advanced Cancers

    This study focuses on a range of advanced cancers, including non-small-cell lung cancer, cutaneous melanoma (a type of skin cancer), renal cell carcinoma (kidney cancer), ovarian epithelial carcinoma, nasopharyngeal carcinoma (cancer in the upper part of the throat), thymic carcinoma (thymus gland cancer), anal cancer, mesothelioma (cancer in the lining of the lungs, stomach, heart, or other organs), esophagogastric cancer (cancer of the esophagus and stomach), high microsatellite instability colorectal carcinoma (a type of colorectal cancer), squamous cell carcinoma of the head and neck, and triple negative breast neoplasms (a subtype of breast cancer that lacks three common receptors).

    The study evaluates the safety and effectiveness of using a new drug named KFA115 both alone and in combination with pembrolizumab, an anti-PD-1 antibody also known as Keytruda. The purpose of this study is to see how safe KFA115 is and to learn more about how well patients tolerate it, whether used alone or in combination with pembrolizumab. The study also aims to determine the best dose to recommend for future studies.

    The study will begin with a dose escalation phase to find the safest dose and understand its side effects. In this part, patients will receive increasing doses of KFA115, either by itself or combined with pembrolizumab, to identify the highest dose they can safely tolerate. Once the best dose is found, the study will enter a dose expansion phase, where more patients will be treated with this dose to see its preliminary effectiveness against cancer and further verify its safety.

    There are multiple patient groups in this study: one group will receive only KFA115, another will start with KFA115 and then add pembrolizumab after one cycle, and the last group will receive both KFA115 and pembrolizumab at the same time.

    By participating in this study, patients may contribute to the development of new cancer treatments that could benefit future patients with similar advanced cancers.

    • KFA115
    • Pembrolizumab
  • Combining immunotherapy and chemoradiotherapy for Anal Cancer treatment

    Anal carcinoma, specifically squamous cell carcinoma of the anal canal, will be the focus of this study. Patients who have not previously received treatment for this type of cancer and are candidates for combined chemotherapy and radiation treatment will participate. This study will examine the effectiveness of adding immunotherapy drugs, Atezolizumab and Tiragolumab, to standard chemoradiotherapy. These drugs help the body’s immune system recognize and attack cancer cells. The main objective is to determine if this combination can achieve a complete response, meaning the cancer completely disappears according to certain medical evaluations.

    Throughout the study, patients will first receive two cycles of Atezolizumab and Tiragolumab along with chemoradiotherapy, which includes the chemotherapy drugs Cisplatin and 5-Fluorouracil, and a specific schedule of radiation therapy. After this initial phase, they will continue with Atezolizumab and Tiragolumab for an additional 24 weeks during a consolidation phase.

    Safety, the effectiveness of treatment, patients’ quality of life, and certain molecular biomarkers in the cancer and blood will be closely monitored throughout the study. Patients can stop the treatment if there are risks of progression, serious side effects, or based on decisions made by themselves or their doctors.

    This study hopes to provide greater insight into whether combining these immunotherapy drugs with standard treatment can improve outcomes for patients with localized squamous cell carcinoma of the anal canal.

    • Atezolizumab plus Tiraglolumab
  • Combining radiotherapy, chemotherapy, and Spartalizumab for treating Metastatic Anal Cancer

    The study concerns patients with metastatic squamous cell anal cancer. The therapy will include a combination of radiotherapy, chemotherapy (docetaxel, cisplatin, 5-fluorouracil) and spartalizumab (anti-PD-1 therapy).

    The aim of the study is to evaluate the effectiveness and safety of the combination of these therapies in patients. Radiotherapy uses radiation to damage the DNA of cancer cells. Chemotherapy involves the use of drugs that kill rapidly dividing cells, including cancer cells. Spartalizumab is an immune medicine that helps the immune system detect and destroy cancer cells. Combining these methods may lead to better treatment outcomes.

    The study is aimed at patients with locally advanced or metastatic squamous cell anal cancer who cannot achieve sufficient improvement with standard types of treatment. Patients will undergo therapy consisting of a combination of the above-mentioned drugs and methods to increase the chance of longer survival without disease progression and achieving complete remissions.

  • Study of Povetacicept for treating autoimmune blood disorders

    This clinical study aims to evaluate the safety and potential benefits of a drug called povetacicept in adults with autoimmune cytopenias, specifically immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease. The study is open-label, meaning both the researchers and participants know what treatment is being administered. Participants will receive povetacicept through a subcutaneous injection approximately every four weeks for six months. There is also a possibility of extending the treatment for an additional six months. The primary goal is to monitor the type, incidence, severity, and seriousness of any adverse events from the first day of treatment through 30 days after the last dose. This study is designed to determine if povetacicept is safe and potentially beneficial in treating these autoimmune conditions.

    • povetacicept
  • Study on the effectiveness and safety of Ianalumab for treating Warm Autoimmune Hemolytic Anemia

    This clinical trial is designed to evaluate the efficacy and safety of a drug called ianalumab in patients with warm autoimmune hemolytic anemia (wAIHA) who have not responded to at least one previous treatment. The study aims to determine if ianalumab can induce and maintain a durable hemoglobin response compared to a placebo.

    Participants will be randomly assigned to receive one of two different doses of ianalumab or a placebo. If a participant assigned to the placebo group does not respond to the treatment, they may be given ianalumab in an open-label manner, meaning both the participant and the doctor will know they are receiving the drug.

    The investigational treatment will be administered through an intravenous (i.v.) infusion. During the study, participants will have regular visits every other week during the treatment period and primary endpoint follow-up period. For safety monitoring, visits will occur monthly for the first 20 weeks after the last dose and then quarterly for up to two years. If a participant achieves a durable response, additional monthly visits for efficacy will continue for the first two years after the last dose, followed by quarterly visits until the loss of response or the end of the study, which could be up to 39 months after the last participant is randomized.

    The primary goal is to see if ianalumab can achieve a durable hemoglobin response, defined as a hemoglobin level of at least 10 g/dL and an increase of at least 2 g/dL from baseline for a period of at least eight consecutive weeks between weeks 9 and 25, without the need for rescue medication or prohibited treatment.

    This study offers hope for patients with wAIHA who have not found success with other treatments, providing a potential new option to manage their condition.

    • placebo
  • A Study of Obexelimab for treating Warm Autoimmune Hemolytic Anemia

    Warm Autoimmune Hemolytic Anemia (wAIHA) is a condition where the body’s immune system attacks and destroys its own red blood cells. This study will examine whether obexelimab can help treat people with wAIHA. Obexelimab is a special type of treatment called a monoclonal antibody, which can target and potentially reduce the activity of some immune cells involved in this disease.

    Study participants will go through different stages. The first stage is a Safety and Dose Confirmation Run-In Period (SRP) lasting for six months. During this time, all participants will receive obexelimab through injections under the skin. This is followed by the Randomized Control Period (RCP), which also lasts for six months. In this stage, participants will be randomly divided into two groups: one group will continue to receive obexelimab, while the other group will receive a placebo.

    After these initial periods, participants will have the chance to continue receiving obexelimab in an Open Label Extension (OLE) period lasting up to a year. Throughout the study, participants will visit the study site for regular checks to ensure the treatment’s effectiveness and safety.

    • Obexelimab
  • 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 of the drugs Tigulixostat and Allopurinol in patients with gout and hyperuricemia

    The study focuses on patients with gout and hyperuricemia. It aims to evaluate the effectiveness and safety of different doses of the drug Tigulixostat compared to allopurinol. Hyperuricemia is a high level of uric acid in the blood, which can lead to gout attacks, causing painful joint inflammations.

    Eligible participants are adults aged 18 to 85, both men and women, with high blood uric acid levels and a history or presence of gout.

    The study will compare three doses of Tigulixostat (100 mg, 200 mg, 300 mg) taken once daily for up to 12 months and allopurinol doses ranging from 100 mg to 800 mg, taken three times daily for the same period. The effect of a placebo taken three times daily for up to 6 months will also be evaluated.

    The primary goal is to assess the number of patients whose blood uric acid levels drop below 6.0 mg/dL over months 4, 5, and 6. Additionally, the study will determine how many patients achieve levels below 5.0 mg/dL and experience at least one gout attack between months 6 and 12 of therapy. The study will also evaluate the total reduction of gout tophi (nodules) and the frequency of adverse side effects.

    • Placebo
    • Tigulixostat
    • Allopurinol
  • Study on safety and tolerability of GS030 Gene Therapy for Retinitis Pigmentosa

    This study is designed to help individuals with a specific type of genetic eye disease called non-syndromic Retinitis Pigmentosa. This condition causes the cells in the retina that detect light to gradually stop working, leading to vision loss. The study will focus on a new gene therapy named GS030-DP and a medical device called GS030-MD.

    The purpose of the study is to evaluate the safety and tolerability of different doses of GS030-DP. This therapy involves a single injection into the eye and uses light stimulation with special glasses (GS030-MD).

    The study is divided into different phases to test the therapy’s effects. Initially, three small groups of participants will receive increasing doses of the gene therapy to determine the safest and most effective dose. Following this, another group will receive the highest well-tolerated dose to further confirm its safety and effect.

    Participants in this trial must have confirmed non-syndromic Retinitis Pigmentosa and will be monitored for any side effects and changes in their vision over time. This will help determine how well the new therapy works and if it improves their vision or quality of life.

    • GS030-DP
  • Study on the safety of SPVN06 Gene Therapy for Patients with Advanced Retinitis Pigmentosa

    Rod-Cone Dystrophy is a genetic eye disorder that can lead to severe vision loss. This study is focused on people with advanced Rod-Cone Dystrophy caused by specific gene mutations in RHO, PDE6A, or PDE6B. These genes play a crucial role in the health of the eye’s photoreceptor cells, which are responsible for capturing light and enabling vision.

    The therapy being tested in this study is called SPVN06. This is a gene therapy designed to correct or replace the faulty gene causing the disease. Gene therapy involves introducing a functioning version of a gene to help the body create the proteins it needs to work correctly.

    The main aim of this study is to assess the safety and tolerability of a single injection of SPVN06 in patients with advanced stages of Rod-Cone Dystrophy.

    The study is divided into two steps:
    1. Step 1: This initial phase involves three groups of participants who will receive different doses of SPVN06 to find the appropriate dose.
    2. Step 2: In this phase, participants will be divided into three groups. Two groups will receive the recommended doses identified in Step 1, while the third group will not receive any treatment.

    Throughout the study, participants will be closely monitored for any side effects and their overall health and vision will be regularly checked. The goal is to gather enough data to determine whether SPVN06 is safe to use and if it can help improve vision in people affected by this genetic disorder.

    • SPVN06
  • Testing gene therapy for retinitis pigmentosa patients with PDE6B gene mutations

    The clinical trial concerns patients with retinitis pigmentosa, a disease in which a part of the eye called the retina degenerates over time. Patients with this disease first have difficulty seeing in the dark and may later lose central vision, which can lead to blindness. This study focuses on a form of retinopathy caused by a mutation in the PDE6B gene.

    The study will use gene therapy using the AAV2/5-hPDE6B vector, which aims to deliver the healthy PDE6B gene to retinal cells. Gene vectors are special tools that help transfer healthy genes into cells. In this study, the vector is inspired by a virus called AAV (Adeno-Associated Virus).

    The study aims to assess the safety and effectiveness of this gene therapy. Patients will be divided into different groups depending on the dose of therapy. The main outcomes will be the incidence of side effects related to the eyes and other parts of the body and improvements in visual functions such as the ability to move, visual field and reading speed. Additionally, the impact of the therapy on the patients’ quality of life will be assessed.