Country: Germany

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  • CT-EU-00118849

    Study of R3R01 for Kidney Conditions: Alport Syndrome and FSGS

    This study focuses on treating Alport Syndrome and Focal Segmental Glomerulosclerosis (FSGS), which are both kidney diseases. The therapy being tested uses a drug called R3R01.

    The study aims to determine if R3R01 can improve kidney function and reduce damage in patients with these conditions. Participants will receive R3R01 for 12 weeks, and researchers will observe the changes in protein levels in their urine, kidney function, and any side effects. This study is designed to evaluate the safety, tolerability, and effectiveness of R3R01 in these patients.

    • R3R01
  • Study on the safety and effects of Vonafexor in patients with Alport Syndrome

    This study focuses on Alport syndrome, a genetic disorder affecting the kidneys. The therapy being tested is Vonafexor, a medication identified as EYP001a. The purpose of this study is to evaluate the safety of Vonafexor and its effects on kidney function in patients with Alport syndrome who are at risk of disease progression.

    The study involves a single group of patients who will receive escalating doses of Vonafexor over a 24-week treatment period, followed by a 12-week follow-up period. The main goals are to assess the safety of the drug and observe changes in kidney function and other renal biomarkers.

    • Vonafexor
  • Long-term safety and efficacy study of PTC518 for Huntington’s disease

    This study focuses on Huntington’s Disease and evaluates the long-term safety and effectiveness of the drug PTC518. Participants, who have previously completed related study phases, will continue taking PTC518 in doses of 5, 10, or 20 milligrams. The study aims to monitor the safety of long-term use and assess how the drug impacts biological markers and symptoms of the disease over a period of 30 months. This is an extension study where all participants will receive the active drug, ensuring continuous monitoring and evaluation of its effects.

    • PTC518
  • 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
  • Evaluating upadacitinib and tocilizumab in pediatric and adolescent patients with active systemic juvenile idiopathic arthritis

    This clinical trial is designed for pediatric and adolescent participants aged 1 to less than 18 years with systemic Juvenile Idiopathic Arthritis (sJIA). The study aims to evaluate the safety and effectiveness of upadacitinib, an oral medication, and includes a reference arm for tocilizumab, which can be administered subcutaneously or intravenously.

    Participants will be assigned to one of two cohorts. Cohort 1 (group) will receive either upadacitinib or tocilizumab, while Cohort 2 will receive upadacitinib only. The treatment period will last 52 weeks, followed by a 30-day follow-up. The study will monitor changes in disease activity and adverse events through regular visits and assessments.

    • Tocilizumab
    • Upadacitinib
  • 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
  • Study of sarilumab in the treatment of juvenile idiopathic arthritis in children and adolescents

    This is a trial that aims to find the right dose of a drug called sarilumab for treating children and teenagers aged 1 to 17 years old with Systemic Juvenile Idiopathic Arthritis. Sarilumab is given as an injection under the skin. The main goal is to understand how the body processes this drug in young patients, so they can receive an adequate dose for treating their condition.

    The study will last for about 166 weeks, which is a little over 3 years. It starts with a 4-week screening period, followed by a 12-week treatment phase where the patients will receive repeated doses of sarilumab. After that, there is a 144-week extension phase where the patients can continue receiving the drug, and finally a 6-week follow-up period.

    During the first 12 weeks, the researchers will closely monitor the levels of sarilumab in the patients’ blood to understand how their bodies handle the drug. They will look at the maximum concentration reached, the total amount of drug exposure over time, and the levels just before each new dose. This information will help them determine the right dose and dosing schedule for children and adolescents with Systemic Juvenile Idiopathic Arthritis.

    In addition to studying the drug levels, the researchers will also evaluate the effectiveness of sarilumab in reducing the symptoms of this condition and monitor any potential side effects to ensure the drug is safe for long-term use in this age group.

    • Sarilumab
  • 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.

  • Study ANV419 as monotherapy or in combination with pembrolizumab and ipilimumab in patients with metastatic melanoma

    The aim of this study is to test a new drug called ANV419. It will be given alone or in combination with other approved cancer medicines such as pembrolizumab or ipilimumab. The main goal is to see how well ANV419 works and whether it is safe for people with advanced cutaneous melanoma, which is a type of skin cancer that has spread or cannot be surgically removed.

    The trial is currently open to adult patients who have already been treated with drugs that target PD-1 or PD-L1 proteins, but whose cancer has continued to progress. The study will have different parts. First, doctors will find the right dose of ANV419 to use alone or in combination with other treatments. They will then check how many patients respond to treatment, which means their tumors shrink or stop spreading.

    • ANV419
    • Ipilimumab
    • Pembrolizumab
  • 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
  • Study of darovasertib in patients with uveal melanoma

    This is a study of a new drug called darovasertib (also known as IDE196 or LXS196) in patients with primary choroidal melanoma. Darovasertib is an oral, potent and selective protein kinase C inhibitor that will be used to treat uveal melanoma.

    The aim of this study is to see if darovasertib can help reduce the size of the tumor before local treatment, such as removal of the eyeball or radiation. Patients will receive darovasertib for a maximum of 6 months before local treatment, and then for a further 6 months after local treatment. Doctors will watch to see if the drug helps avoid having to remove the eyeball or reduce the dose of radiation needed to treat the tumor.

    It is important to monitor for any side effects and changes in laboratory tests while taking darovasertib. Doctors will closely monitor the patient’s health throughout the study, which may last up to 3 years.

    • Darovasertib
  • Study of Fidrisertib/IPN60130 in the treatment of Fibrodysplasia Ossificans Progressiva (FOP)

    The aim of this study is to test a new drug called fidrisertib (also known as IPN60130) to treat a rare disease called Fibrodysplasia Ossificans Progressiva, or FOP. FOP is a grave disease that causes bones to start growing in places they shouldn’t, such as muscles and soft tissues. This causes a lot of pain, swelling, and stiffness in the joints, making movement difficult.

    In the study, some participants will be given the new drug fidrisertib at two different doses, and others will be given a dummy treatment called a placebo. Researchers will monitor the situation closely, performing special tests called low-dose whole-body computed tomography (WBCT) to measure new bone growth. For some older participants, they may also use another type of test called fluorine-18-labeled sodium fluoride positron emission tomography – computed tomography to check bone growth.

    • IPN60130
    • placebo
  • A study comparing biosimilar nivolumab and nivolumab in the treatment of resected melanoma

    The aim of this study is to test whether a new drug called ABP 206 (biosimilar nivolumab) works as well as the approved cancer drug OPDIVO® (nivolumab) in people with advanced cutaneous melanoma that has been surgically removed. The study divided people into 3 groups: one group will receive ABP 206, the second will receive real OPDIVO® approved in the US, and the third will receive the version of OPDIVO® approved in Europe. All of these medicines will be given through an intravenous drip every 4 weeks for up to 1 year, or until the cancer comes back or gets significantly worse.

    The main goal is to check whether ABP 206 (biosimilar nivolumab) is absorbed and maintained in the body in the same way as OPDIVO®. Researchers will also closely monitor how well it works, what the side effects are, and whether the body produces antibodies against it. The entire study will last approximately 13 months for each person joining.

    • Nivolumab biosimilar
    • Nivolumab
  • Study of a new drug – DYP688 for patients with uveal melanoma and other melanomas with the GNAQ/11 mutation

    This study is testing a new drug called DYP688 for people with metastatic uveal melanoma. It is a type of eye cancer that has spread to other parts of the body. Other types of cutaneous melanoma that have certain gene mutations called GNAQ/11 are also being studied.

    The process consists of two main parts. The first part, called the dose escalation phase, aims to find the highest safe dose of DYP688 that can be given without too many side effects. This section includes patients with metastatic uveal melanoma and other melanomas with a GNAQ/11 mutation.

    Once the right dose is determined in the second part, called Phase II, DYP688 will be tested in three groups of patients: people with metastatic uveal melanoma who have previously received another medicine called tebentafusp, people with metastatic uveal melanoma who has not received tebentafusp before, and the third group with melanomas with the GNAQ/11 mutation.

    The main goal is to see how well DYP688 works at reducing or stopping the development of these cancers and to see if there are any serious side effects.

    • DYP688
  • 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