Country: Poland

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  • CT-EU-00118673

    Study WVE-003 in patients with early-stage Huntington’s disease

    This clinical trial is a study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a new drug called WVE-003 in adult patients with early Huntington’s disease (HD). WVE-003 is a type of drug designed to target specific genetic sequences. In this case, it is targeting a single nucleotide polymorphism (SNP), known as SNP3, in Huntington’s disease patients. The drug is administered intrathecally, i.e., it is injected into the spinal canal.

    The study is double-blind, meaning neither patients nor researchers know who is receiving the actual drug and who is receiving the placebo. This helps ensure the results are impartial. The primary goal is to evaluate the safety of WVE-003 by monitoring the percentage of patients who experienced adverse events from day 1 to the end of the study, which lasts a minimum of 36 weeks.

    • WVE-003
  • A study on the safety and effectiveness of AMT-130 in the treatment of early Huntington’s disease in adults

    This clinical trial focuses on evaluating the safety and effectiveness of a new treatment called AMT-130 in adults with early symptoms of Huntington’s disease (HD). The goal is to collect data on the effectiveness of AMT-130 in sick patients.

    In the study, participants in Cohort 3 (Group 3) will receive either a high or low dose of AMT-130. Participants in this cohort will also receive immunosuppressive therapy consisting of dexamethasone, sirolimus, and rituximab. At the end of the month, 36 visit, participants will be informed about their assigned treatment group. The goal is to further evaluate the safety and effectiveness of low or high dose AMT-130.

    The study aims to expand the number of patients exposed to two doses to provide a sufficient sample for safety and effectiveness comparisons. The study will be conducted in approximately 5 to 8 European Huntington’s disease centers, 2 of which will serve as surgical centers. Both studies will share a common set of clinical, safety, imaging, and biomarker assessments over 5 years of follow-up.

    The main objectives of the study include assessing the safety and tolerability of administering AMT-130 to both hemispheres of the brain. This is a type of therapy that reduces the level of the HTT gene in adults with early symptoms of Huntington’s disease. The evaluation will include various parameters such as adverse events, changes in blood pressure, respiratory rate, heart rate, electrocardiograms, neurological and physical examinations, as well as laboratory tests such as clinical chemistry, hematology, urinalysis and cerebrospinal fluid analysis.

    • AMT-130
  • 2019/ABM/01/00024

    Rituximab treatment for children with idiopathic nephrotic syndrome

    This clinical trial focuses on idiopathic nephrotic syndrome (INS), a kidney disorder causing excessive protein loss in the urine, leading to swelling and other complications. The study aims to evaluate the safety and effectiveness of rituximab for children aged 24 months to 16 years with steroid-dependent nephrotic syndrome (SDNS) or frequently relapsing nephrotic syndrome (FRNS).

    Participants will be randomly assigned to receive either rituximab or a placebo during a double-blind phase lasting up to 365 days. Following this period, all participants will receive rituximab in an open-label extension phase. The study will monitor the time to the first relapse, assess disease progression, and observe any adverse effects. Regular health assessments, including physical exams, blood tests, and monitoring of disease progression, will be conducted throughout the trial to ensure the safety and well-being of the participants. The goal is to determine if rituximab can extend the period of remission and reduce the frequency of relapses in children with INS.

    • rituximab
    • placebo
  • Evaluating the safety and effectiveness of Fazirsiran in treating alpha-1 Antitrypsin Deficiency-associated liver disease

    This clinical trial is focused on a disease known as Alpha-1 Antitrypsin Deficiency (AATD). In this condition, the liver produces an abnormal form of the alpha-1 antitrypsin (AAT) protein, called Z-AAT. This abnormal protein builds up in the liver, causing damage and leading to liver scarring (fibrosis), continued liver damage (cirrhosis), and can eventually progress to severe liver disease.

    The study aims to test the safety and effectiveness of a drug called Fazirsiran (also known by its code names TAK-999, ARO-AAT, and ADS-001). Fazirsiran is designed to reduce the amount of the harmful Z-AAT protein in the liver, potentially slowing down or stopping the damage it causes.

    Participants in the study will be randomly assigned to receive either Fazirsiran or a placebo. This will be done to compare the effects of the drug with no treatment. Participants will receive Fazirsiran through injections and will be monitored over an extended period, with some receiving the treatment for up to 100 weeks. The study includes regular assessments to check for any side effects and to measure the drug’s impact on liver health and the levels of Z-AAT protein in the body.

    • placebo
    • Fazirsiran Injection
  • Evaluating the pharmacokinetics, safety, and tolerability of Filgotinib in children and teenagers with juvenile idiopathic arthritis

    This clinical trial focuses on children and teenagers aged 8 to less than 18 years who have Juvenile Idiopathic Arthritis (JIA). The study aims to evaluate the pharmacokinetics, safety, and tolerability of filgotinib, an oral medication.

    Participants will be divided into three groups based on their body weight and will receive different doses of filgotinib in the form of film-coated tablets taken once daily. The trial will monitor the maximum concentration of the drug in the blood, the area under the concentration-time curve, and any adverse events over a period of up to 96 weeks.

    • Filgotinib
  • Baricitinib study in children with juvenile idiopathic arthritis

    This clinical trial is designed to test whether Baricitinib is safe and effective in the treatment of systemic juvenile idiopathic arthritis in children aged 1 to 18 years. Participants will be assigned to one of two groups. In the first group, some participants will receive Baricitinib and others Tocilizumab as the reference drug. In the second group, all participants will receive Baricitinib.

    The primary objective of the study is to evaluate the percentage of participants who experience at least a 30% improvement in disease symptoms after 12 weeks of treatment according to the modified American College of Rheumatology Pediatric Response Criteria (PediACR30). Baricitinib is administered orally and Tocilizumab is administered by subcutaneous injection.

    • Tocilizumab
    • baricitinib
  • Study of ustekinumab and guselkumab in young patients with juvenile psoriatic arthritis

    This here clinical trial is aimin’ to study two different medicines, ustekinumab and guselkumab, for treatin’ a condition called juvenile psoriatic arthritis. This is a type of arthritis that affects young’uns and causes joint pain, swellin’, and stiffness.

    The study will have two groups, one group takin’ ustekinumab and the other takin’ guselkumab. These medicines work by targetin’ certain proteins in the body that cause inflammation, which is the root cause of the arthritis symptoms.

    The main goal of the study is to see how well these medicines work in reducin’ the symptoms of juvenile psoriatic arthritis, like joint pain and swellin’. The study will also look at how the body handles these medicines and if they cause any side effects.

    The study will last for about a year and a half, with regular check-ups and assessments to monitor the participants’ progress.

    • Ustekinumab
    • Guselkumab
  • Study of Adalimumab and Risankizumab in the treatment of juvenile psoriatic arthritis in children

    This clinical trial is evaluating the safety and effectiveness of Risankizumab in the treatment of juvenile arthritis with psoriasis in children. It is a type of arthritis in which the immune system attacks healthy cells and tissues, causing pain, stiffness and swelling in the joints.

    About 40 young participants with juvenile psoriatic arthritis will be randomized to receive Risankizumab or the already approved treatment Adalimumab. Participants will receive medications in the form of subcutaneous injections for 24 weeks. Those who find the treatment effective will continue for another 100 weeks.

    During the study, participants will regularly visit a hospital or clinic where they will undergo medical tests, blood tests, check for side effects and complete questionnaires. This allows us to assess the effectiveness and safety of risankizumab in the treatment of juvenile psoriatic arthritis in children.

    • Risankizumab
    • Adalimumab
  • Study of Pembrolizumab/Quavonlimab Combination vs Other Treatments for Colorectal Cancer

    This here clinical trial is aimin’ to take a good look at a new combination treatment called co-formulated pembrolizumab/quavonlimab for folks with stage IV colorectal cancer that’s got that microsatellite instability-high or mismatch repair deficient business goin’ on. The main goal is to see how well this new combo treatment works at shrinkin’ them tumors, compared to some other treatments out there.

    Now, the real important part is that the doctors’ll be keepin’ a close eye on how many folks get what they call an objective response, meanin’ their tumors either disappear completely or shrink down by at least 30%. They’ll be trackin’ this over a span of up to around 50 months to get a good picture of how effective this new treatment is.

    Safety’s always a top priority too, so the doctors’ll be watchin’ out for any side effects or issues that might crop up with this new combo treatment. It’s all about findin’ the best way to fight that cancer while keepin’ folks as comfortable as possible.

  • To evaluate a combination of 3 different drugs versus 2 other drugs in the treatment of patients with melanoma

    This study compares two different approaches to treating advanced melanoma, a type of skin cancer that has spread to other parts of the body. This study is specifically aimed at patients with a gene mutation called BRAF who have previously received treatment with drugs such as nivolumab or pembrolizumab.

    One therapeutic approach involves taking three study drugs: pembrolizumab administered intravenously every 3 weeks, along with encorafenib and binimetinib taken orally daily at home. The second approach involves taking two study drugs: ipilimumab and nivolumab administered intravenously every 3 weeks for the first 4 doses, followed by nivolumab alone every 4 weeks. Both treatments will last for approximately 2 years, but there is no time limit for treatment with encorafenib and binimetinib.

    The research team will closely monitor the patients’ health during regular clinic visits to see how they are responding to treatment. The main goal is to determine which treatment method is more effective in shrinking or eliminating melanoma tumors.

    • Nivolumab
    • Ipilimumab
    • Binimetinib
    • Encorafenib
    • Pembrolizumab
  • Study of an experimental drug TL-895 for myelofibrosis or indolent systemic mastocytosis

    This here clinical trial is studying a new experimental drug called TL-895. TL-895 is taken by mouth and works by blocking certain proteins called tyrosine kinases that are involved in causing myelofibrosis and indolent systemic mastocytosis.

    Participants in the study will receive TL-895 orally in varying doses based on their specific group assignment. These doses range from 150 mg to 450 mg, and the administration could be either once or twice daily, continuing in a consistent 28-day cycle. The primary goal of the study is to determine the recommended phase 2 dose (RP2D) for TL-895 in each patient group based on safety and tolerability data. Additionally, the study aims to assess the effectiveness of TL-895 in reducing spleen volume and improving symptoms associated with Myelofibrosis over a 24-week period.

    • TL-895
  • Treatment for Herniated Disc in the Lower Back

    Howdy there, partner! This here clinical trial is aimin’ to test out a new treatment called STA363 for folks sufferin’ from a herniated disc in their lower back, causin’ that darn sciatic nerve pain. The main goal is to see if this treatment is safe an’ if it can help shrink that bulgin’ disc an’ ease up on the pain.

    Here’s the deal: they’ll be injectin’ either STA363 or a placebo (a fake treatment) right into that herniated disc. About two-thirds of the folks will get the real STA363, while one-third will get the placebo. The docs will be keepin’ a close eye on things to make sure there ain’t no nasty side effects or problems.

    They’ll be takin’ pictures of your back with one of them fancy MRI machines before an’ after the treatment to see if the disc an’ herniation shrink up. You’ll also be keepin’ track of your pain levels every day for a week after the treatment.

    The whole shebang will take about 6 months, with check-ups along the way to make sure everythin’ is goin’ smooth. If this STA363 treatment works like they hope, it could be a game-changer for folks like you sufferin’ from that darn back pain.

    • Lactic Acid
    • placebo
  • Study on Secukinumab for Rotator Cuff Tendinopathy

    This clinical trial evaluates the efficacy of the drug secukinumab in treating moderate to severe rotator cuff tendinopathy. Participants will receive secukinumab or a placebo, both in conjunction with standard care, to see if there is an improvement in symptoms and physical function. The research is conducted through a controlled setup where neither the participants nor the researchers know who receives the drug or the placebo to ensure unbiased results. This research aims to provide valuable insights into the potential benefits of secukinumab for those struggling with this shoulder condition.

    • placebo
    • Secukinumab
  • Study of DYP688 in patients with metastatic uveal melanoma

    The aim of this study is to test a new drug combination to treat metastatic uveal melanoma, a type of cancer that starts in the eye and spreads to other parts of the body. The main drugs being tested are IDE196 (also called darovasertib) and crizotinib, both taken by mouth twice daily.

    Currently, this process is divided into several stages. In the first part, investigators will test two different doses of IDE196 in combination with crizotinib and compare them to other approved therapies such as pembrolizumab, ipilimumab + nivolumab, or dacarbazine. Once they determine the best dose of IDE196, they will move to the next step in which everyone will receive that dose along with crizotinib or one of the other treatments.

    Researchers will primarily look at how long the cancer stays under control without getting worse and how long patients live. It could take about 4 years to get all the answers you need.

    • Darovasertib/IDE196
    • Dacarbazine
    • Nivolumab
    • Crizotinib
    • Ipilimumab
    • Pembrolizumab
  • Study assessing the effectiveness of Tebentafusp administered alone and in combination with Pembrolizumab in the treatment of advanced melanoma

    The aim of this study is to test new treatments for people with advanced skin melanoma that does not respond well to other therapies. The main focus was on a new experimental drug called tebentafusp, which is a special type of protein that helps the body’s immune system recognize and attack cancer cells.

    The study divided patients into three different groups. One group will receive tebentafusp alone. Another group will receive tebentafusp in combination with another immunotherapy drug called pembrolizumab. The third group will receive the treatment that the doctor thinks is best for the patient – this could be another experimental drug, standard therapy, or simply supportive care.

    Scientists are primarily focusing on the effectiveness of these treatments in shrinking tumors and extending patient survival. They will also monitor closely for any side effects to make sure the treatment is safe. The study is expected to last about two years and will include frequent check-ins to monitor patient responses.

    • Tebentafusp
    • Pembrolizumab
  • Safety and efficacy of pembrolizumab in combination with investigational drugs in the first-line treatment of patients with melanoma

    The aim of this study is to test new experimental treatments for melanoma, which is a type of skin cancer. The main goal is to test whether these new treatments are safe and effective when used alone or in combination with the drug pembrolizumab.

    The current study includes several different treatment groups. Some groups receive pembrolizumab in combination with other investigational drugs such as vibostolimab, quavonlimab, lenvatinib, favezelimab, or Tretynoina (ATRA). Other groups simply receive pembrolizumab alone.

    Scientists will carefully look at factors such as dose-limiting toxicities and adverse events to make sure the treatment is safe. They will also check the effectiveness of the therapy by measuring, for example, the objective response rate, which shows whether tumors are shrinking or disappearing.

    • Tretynoina
    • Vibostolimab
    • Quavonlimab
    • Favezelimab
    • Pembrolizumab
    • Lenvatinib
  • 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 of the drug combination mRNA-4157/V940 and Pembrolizumab in the treatment of melanoma

    The aim of this clinical trial is to test whether a new drug called mRNA-4157/V940 in combination with pembrolizumab can help prevent the recurrence of melanoma in people who have already had it. Currently, mRNA-4157/V940 is what is called “individualized neoantigen therapy,” which means it is a therapy created specifically for each patient based on their cancer cells. Doctors give this drug along with pembrolizumab, a drug that helps the immune system fight cancer cells.

    The main goal of this study is to determine whether taking V940 and pembrolizumab together is more effective in preventing melanoma recurrence than taking pembrolizumab alone. Researchers will closely monitor how long it takes for the cancer to return or spread. The study will last for approximately 74 months.

    • mRNA-4157/V940
    • placebo
    • Pembrolizumab
  • Trial of KRT-232 and Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia

    This here clinical trial is looking at a new drug called KRT-232 for treating chronic myeloid leukemia, which is a type of blood cancer. The study aims to see if KRT-232, when taken along with other approved drugs like dasatinib or nilotinib, can help patients whose leukemia has come back or stopped responding to those other drugs.

    KRT-232 works by blocking a protein called MDM2, which normally keeps cancer cells alive. The main goals are to find the highest safe dose of KRT-232 that can be given with dasatinib or nilotinib, and to see if the combination can get patients’ leukemia under better control.

    This is an open-label study, meaning both patients and doctors know what treatment is being given. Patients must have chronic myeloid leukemia that has relapsed or become resistant to prior treatment with a tyrosine kinase inhibitor drug like dasatinib or nilotinib.

    • KRT-232
    • Dasatinib
    • Nilotinib
  • Study of asciminib dosing and safety in pediatric patients with Chronic Myeloid Leukemia

    This study is designed to determine the appropriate dosing and assess the safety of the drug asciminib for children and teenagers who have a specific type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML-CP). These patients have previously been treated with at least one other medication known as a tyrosine kinase inhibitor (TKI). The study involves giving different doses of asciminib to see how well the drug works and how safe it is in young patients. The study will enroll participants into two age groups and will follow them over a five-year period to observe the effects of the treatment.

    • Asciminib