Country: Czechia

Currently showing 20 clinical trials. Use pagination links to see more trials.

  • CT-EU-00117573

    Study of Combination Therapy for Melanoma After Anti-PD-1 Treatment

    This clinical trial is comparing two different treatment approaches for advanced melanoma, which is a type of skin cancer that has spread to other parts of the body. If you have a specific gene mutation called BRAF and have previously received treatment with certain immunotherapy drugs like nivolumab or pembrolizumab, you may be eligible for this study.

    One treatment approach involves receiving three study medicines: pembrolizumab given through an IV every 3 weeks, along with encorafenib and binimetinib taken by mouth daily at home. The other approach involves receiving two study medicines: ipilimumab and nivolumab given through an IV every 3 weeks for the first 4 doses, followed by nivolumab alone every 4 weeks. Both treatment approaches will be given for around 2 years, but there is no time limit for the encorafenib and binimetinib treatment.

    The study team will closely monitor your condition during regular visits to the clinic to see how you are responding to the treatment. The main goal is to determine which treatment approach is more effective in shrinking or eliminating the melanoma tumors. Around 150 participants will be enrolled in this study and randomly assigned to one of the two treatment groups.

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  • Study of a New Drug for Moderate to Severe Rotator Cuff Tendinopathy

    This here clinical trial is aimin’ to see if a new medicine called secukinumab can help folks with moderate to severe rotator cuff tendinopathy, which is a painful condition affectin’ the shoulder. The study will compare secukinumab to a placebo, which is like a fake medicine with no real effects.

    Now, if you join this trial, you’ll be given either secukinumab or the placebo by injection under the skin every week or so for the first few months. The doctors won’t know which one you’re gettin’ until later. You’ll also need to keep takin’ any anti-inflammatory medicines and doin’ physical therapy exercises as you normally would.

    The main thing the researchers are lookin’ at is whether secukinumab can better improve your physical shoulder symptoms like pain, weakness, stiffness, and such compared to the placebo. They’ll be askin’ you to rate your symptoms at different points durin’ the 24-week study.

    It’s important to know that you can’t increase your anti-inflammatory medicine doses or get steroid injections durin’ the study, but you can take other pain meds like acetaminophen if needed. The study involves some medical tests too, like MRI scans and X-rays of your shoulder.

    So in a nutshell, this trial aims to find out if secukinumab works better than a placebo at relievin’ the symptoms of rotator cuff tendinopathy when combined with standard treatments like physical therapy and anti-inflammatory drugs. If you’re interested, you’d be closely monitored and get either the new medicine or a placebo for free as part of the study.

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  • Comparing a Denosumab to Prolia® in postmenopausal women with osteoporosis

    This here clinical trial is a Phase 3 study aimin’ to compare a new biosimilar drug called Enzene Denosumab (ENZ215) with the already approved drug Prolia®. The study is lookin’ for postmenopausal women with osteoporosis, which is a condition where the bones become weak and brittle.

    The main goal is to see if this new drug ENZ215 works just as well as Prolia® in increasin’ the bone mineral density in the lower back over a period of 360 days. They’ll be measurin’ this by takin’ special X-ray scans called DXA scans.

    Another important thing they’ll be checkin’ is how the two drugs affect the levels of a certain protein in the blood called C-telopeptide of Type-1 collagen (sCTX). This protein is a marker of bone breakdown, so they’ll be lookin’ at how much it changes over the first 180 days of the study.

    Overall, this study aims to see if this new biosimilar drug ENZ215 is just as good as Prolia® in treatin’ osteoporosis in postmenopausal women, both in terms of increasin’ bone density and reducin’ bone breakdown.

    Czechia
  • NCT05608291

    This here clinical trial, folks, is aimin’ to see if a new combination of drugs called fianlimab and cemiplimab works better than a drug called pembrolizumab at preventin’ or delayin’ that darn melanoma cancer from comin’ back after it’s been removed with surgery. Now, pembrolizumab is already approved for this purpose in some countries, but these researchers reckon this new combo might just do an even better job.

    The main goal is to see if this fianlimab and cemiplimab combo is an effective treatment compared to pembrolizumab for folks who’ve had their melanoma removed but are still at high risk of it comin’ back. But they’re also gonna be keepin’ an eye out for any side effects from these new drugs, how much of the drugs are in the blood at different times, and whether the body makes antibodies against ’em, which could make ’em less effective or cause side effects.

    They’re even gonna look at how takin’ these drugs might improve a person’s quality of life. So if you’re interested in joinin’ this trial, you’d be helpin’ to find out if this new combo is the bee’s knees for keepin’ that darn melanoma from comin’ back and botherin’ ya again.

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  • 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.

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  • 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.

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  • 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.

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  • Study of the new oral drug LY3871801 for rheumatoid arthritis

    The aim of this study is to test a new drug called LY3871801 for people suffering from moderate to severe rheumatoid arthritis. The main goal is to see if this new drug can help reduce disease activity and improve symptoms better than a placebo. In the first part of the study, doctors will check how much the Disease Activity Score changes after 12 weeks of taking LY3871801 or a placebo. Then, in the second part, they will look at what percentage of patients experience significant improvement, defined as achieving an ACR50 response, which means reducing symptoms of rheumatoid arthritis by 50% or more. Both the real drug and the placebo will be taken by mouth.

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  • Evaluating SAR441566 in Adults with Moderate-to-Severe Rheumatoid Arthritis

    This clinical trial is designed to explore the effectiveness and safety of a new medication called SAR441566 in adults who are dealing with moderate-to-severe rheumatoid arthritis (RA). If you’re an adult who hasn’t found relief from RA with methotrexate alone and haven’t tried biologic or targeted synthetic disease-modifying anti-rheumatic drugs yet, this study might be of interest to you.

    The study is set up as a double-blind, placebo-controlled experiment, which means neither you nor the study team will know if you’re receiving the actual medication or a placebo. This is a key part of ensuring the results are unbiased. You’ll be randomly placed into one of five groups, with some receiving SAR441566 and others a placebo, all alongside your regular methotrexate treatment.

    The trial will last for about 149 days, including a 6-week period before the treatment starts to confirm your eligibility, a 12-week treatment phase, and a 2-week follow-up period after treatment ends to monitor your safety. Throughout the study, you’ll visit the study center 8 times.

    One of the main goals of this study is to see if participants show a significant improvement in their RA symptoms, specifically looking for a 20% improvement in the American College of Rheumatology (ACR) score by week 12. This score measures various aspects of RA, including joint tenderness and swelling, pain levels, and overall physical function.

    By participating, you’ll be contributing to research that could lead to new treatment options for RA, potentially offering relief to many who are searching for more effective therapies.

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  • 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.

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  • Continued Parsaclisib treatment for B-cell cancer patients

    This is a phase II clinical trial focused on providing continuation of treatment with a drug called parsaclisib to people diagnosed with B-cell malignancies. The main goal of this study is to expand the treatment regimen established in the previous study. Study participants will receive parsaclisib as a stand-alone therapy (monotherapy) or in combination with other therapeutic agents, which may include itacitinib, ruxolitinib or ibrutinib. The study aims to facilitate participants’ ongoing care and contribute to the broader field of medical research by collecting data on the effectiveness and safety of prolonged use of parsaclisib.

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  • Extended safety study for participants using spartalizumab alone or combined

    This study relates to a type of medication called spartalizumab. The goal is to find out if this medicine, when given alone or with other treatments, is safe and doesn’t cause any unwanted side effects. The study is open to people who have already been involved in past studies for spartalizumab. The reason for this is to keep giving these people access to the treatment while also continuously assessing its safety.

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  • Examining capivasertib and docetaxel in advanced prostate cancer

    This trial is testing a new potential treatment for a type of advanced prostate cancer. The study will compare two combinations: one with Capivasertib and another called Docetaxel, compared with placebo (a dummy tablet with no medical effect) and Docetaxel. In addition, each study participant will receive steroid treatment and another therapy called androgen deprivation therapy. The main goal of this study is to demonstrate whether Capivasertib + Docetaxel extends patients’ lives more than placebo + Docetaxel. They will also be monitored for the time it takes for the cancer to show signs of growth again, for the pain to increase or for urinary symptoms to worsen.

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  • 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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  • Exploring the safety of seladelpar in treating primary biliary cholangitis

    This is a long-term study on a drug named seladelpar for people with a liver disease called Primary Biliary Cholangitis (PBC). The main goal is to see if this drug is safe and easy for patients with PBC to use over a long period. A secondary goal is to see if seladelpar can effectively treat PBC and improve the patient’s quality of life. The study will track a few things, like if there are changes in the patient’s liver health which may lead to hospitalization or if the patient’s liver enzymes like alkaline phosphate and bilirubin level normalize or not after taking this drug.

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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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  • Assessing imatinib inhalation therapy for pulmonary arterial hypertension

    This clinical study aims to evaluate the safety and efficacy of an inhaled treatment called imatinib (AV-101) for patients with Pulmonary Arterial Hypertension (PAH). The trial is divided into two parts: Phase 2b and Phase 3. In Phase 2b, researchers will test three doses of AV-101 to identify the optimal dose for Phase 3. They will check this by measuring the resistance of the lung vessels — less resistance means the medicine is working. In the following Phase 3, the primary outcome will be the change in the 6-minute walk distance after 24 weeks of treatment compared to a placebo. Participants must be between 18 and 75 years old, have a diagnosis of PAH, and meet specific criteria regarding their disease severity and concomitant therapy.

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  • Testing a new combination therapy with acalabrutinib for a specific type of lymphoma

    This clinical trial is investigating a new combination therapy for diffuse large B-cell lymphoma, a type of lymphoma. The treatment combines Acalabrutinib, a targeted therapy drug, with R-CHOP, a chemotherapy mix consisting of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone, a standard chemotherapy regimen. The aim of the study is to evaluate the safety and effectiveness of this combination in improving patient outcomes. It focuses on patients who have not been previously treated for lymphoma. The study aims to find better treatment strategies for this particular type of lymphoma.

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