There are about 36633 clinical studies being (or have been) conducted in France. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This is a single-arm long-term extension study that will enroll participants with PNH who have completed participation in Alexion-sponsored clinical studies with danicopan as an add on therapy to a C5i.
The main purpose of this trial is to investigate what happens to the trial drug in the body and to confirm that it is safe to use and effective for treating atopic dermatitis (AD) in children. The trial will last up to maximum of approximately 194 weeks, and there will be up to 59 visits. The visits will be held approximately every second week for the first 68 weeks, then the visits will be held every six weeks for the rest of the treatment period. From week 26, every second visit will be held by phone and every second visit will be held on site. The first part of the trial is called a screening period and will last between 2 and 6 weeks. After the screening period, the trial drug will be administered to the child by subcutaneous (SC) injection. The treatment period with tralokinumab is divided in 3 parts: 1.) initial treatment period for 16 weeks, 2.) open-label treatment period for 52 weeks and 3.) long-term extension treatment period for up to 106 weeks followed by a 14-week safety follow-up period. All children will use an emollient twice daily (or more) for at least 14 days prior to start of treatment and will continue this treatment throughout the trial. If medically necessary, rescue treatment for AD is allowed at the discretion of the trial doctor.
The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.
This is an open-label, single arm, multi-center study. Approximately 28 participants aged 2 to <18 years will be enrolled stratified as 2 to 5 years and 6 to < 18 years. The study is comprised of 3 periods, Screening (up to 45 days), Treatment (1 day), and Follow-up (52 weeks).
Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin-17A, to which it binds with high affinity. This study investigates izokibep in subjects with active non-infectious, intermediate-, posterior- or pan-uveitis requiring high-dose steroids.
This Phase 1b/2a study will assess the efficacy, safety, and pharmacodynamics of CyPep-1 when administered directly into measurable tumor lesions in combination with the anti-PD-1 antibody pembrolizumab. Additionally, the study will assess anti-tumor effects of CyPep-1 on injected lesions and non-injected target lesions identified at baseline, as well as local and systemic immunological effects of CyPep-1 in combination with pembrolizumab.
This is a Phase IIa study to assess efficacy and safety of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD). This study will consist of a Screening Period of up to 15 days and an 18-month Double-Masked Treatment Period, including 9 individual visits to the study site.
Observational, noninterventional, 3-year study to examine the presence of detectable differences in neurocognitive, developmental, motor, neurophysiologic, and quality of life measures over time in patients with cyclin-dependent kinase-like 5 deficiency disorder.
The purpose of the current ZOSTER-101 long-term follow-up (LTFU) study of ZOSTER-049 (NCT02723773) study, an extension of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies, is to assess the long-term vaccine efficacy (VE) against Herpes Zoster (HZ) (approximately 11-15 years post primary vaccination in ZOSTER-006/022 studies), persistence of immunogenicity and safety of GSK's Herpes Zoster subunit (HZ/su) vaccine in older adults. The persistence of immunogenicity and safety of 1 or 2 additional doses (0, 2-month schedule) of HZ/su vaccine administered to a small group of participants in ZOSTER-049 study (approximately 5 years after the initial vaccination in ZOSTER-006/022 studies) will also be assessed.
Myelodysplastic syndromes (MDS) are bone marrow malignant diseases resulting in ineffective haematopoiesis and subsequently, blood cell count decrease. Patients have anaemia responsible of fatigue and high heart frequency, thrombocytopenia responsible of increased risk of bleeding and neutropenia responsible of increased risk of infection. The patients suffering from MDS also are at increased risk of developing acute myeloblastic leukemia (AML). Allogeneic stem cell transplantation (alloSCT) remains the only curative option for patients with aggressive MDS. However, these patients are frequently ineligible for this kind of treatment, because of, for instance, age and co-morbidities. Thus, other treatment options are needed and Azacytidine (AZA), a hypomethylating agent is then proposed. With this COMYRE observatory study, we wanted to analyse which patients undergo alloSCT, why they are not eligible to alloSCT if it is the case, the overall survival of all the patients and if there are some factors which can influence this survival. It could help us to better identify the best candidate for alloSCT and those for other treatments such as AZA.