Oswiecim

Researchers are evaluating the effectiveness and safety of Xeomin injections in preventing chronic migraine. This Phase 3 clinical trial compares Xeomin to placebo injections given into muscles of the head and neck. Participants have chronic migraine diagnosed for at least 12 months and meet specific headache and migraine day criteria. The study aims to measure changes in monthly migraine days over time with Xeomin treatment. Participants will receive four treatments spaced about 12 weeks apart over a total study duration of 52 to 55 weeks. The treatments involve injections of either Xeomin or placebo solution prepared with sodium chloride. Visits occur approximately every 4 weeks, totaling 14 visits: the first, last, and four treatment visits are on-site, while the other eight visits are remote via phone or video call. During the study, participants will keep headache diaries to track migraine and headache days. Researchers will focus on the change in monthly migraine days from baseline to six months after the first injection. Safety and effectiveness are monitored throughout, with frequent assessments during both on-site and remote visits to ensure accurate tracking of migraine symptoms and any side effects.

Researchers are evaluating the effect of Xeomin injections compared to placebo injections for preventing episodic migraine. This phase 3 clinical trial focuses on adults who experience episodic migraine, aiming to measure changes in the number of migraine days per month. Participants must have a diagnosis of episodic migraine for at least 12 months and meet specific headache frequency criteria. Participants will receive four treatments of either Xeomin or placebo injections into muscles of the head and neck, with treatments spaced about 12 weeks apart. The entire trial lasts approximately 52 to 55 weeks, beginning with a screening period of 4 to 5 weeks. There are about 14 visits in total, with the first, last, and four treatment visits conducted on-site, while the other visits are held remotely via phone or video. Throughout the study, participants will track their migraine days using a headache diary, and researchers will assess changes in monthly migraine frequency from baseline to six months after the first injection. Regular monitoring includes both in-person and remote assessments. The primary outcome focuses on the change in monthly migraine days between baseline and month six after treatment initiation.

Researchers are evaluating the safety and potential benefits of VHB937 in people aged 50 to 85 years with early Alzheimer's disease, including those diagnosed with Mild Cognitive Impairment due to Alzheimer's or mild Alzheimer's disease. This Phase II, multicenter, randomized, double-blind, placebo-controlled study aims to assess how VHB937 affects memory, thinking abilities, daily activities, and brain changes, while also studying how the body processes and responds to the treatment. The study includes an initial 72-week double-blind phase followed by an extension period. Participants will receive either VHB937 solution for infusion or a placebo solution through infusion during the 72-week double-blind phase. The study compares these two groups to evaluate the effects and safety of VHB937 in early Alzheimer's disease. After the double-blind phase, participants may continue in an extension period for further observation. Treatment involves regular infusions under controlled conditions throughout the study. During the study, participants and their study partners will attend visits for assessments including memory and cognitive tests, evaluations of daily functioning, brain imaging, and biomarker analysis from cerebrospinal fluid or PET scans. Researchers will monitor safety, record any side effects, and track changes using the Clinical Dementia Rating scale (CDR) over 72 weeks. The study requires a reliable partner to accompany participants to visits, and overall participation includes monitoring during treatment and the extension phase to thoroughly assess VHB937's effects and safety.

Researchers are evaluating VENT-03 to see if it can treat adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). The study also aims to learn about the safety of VENT-03 and how the body processes it. Participants will be compared to those receiving a placebo to determine if VENT-03 affects disease activity and severity, as well as to monitor any side effects. Participants will take either VENT-03 tablets or placebo tablets for 4 weeks in a double-blind phase. After this, all participants will switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study involves monthly clinic visits for checkups and tests throughout the treatment periods. During the study, researchers will assess the effect of VENT-03 on the interferon gene signature in the skin from baseline to the end of the double-blind treatment (up to Day 28). Participants will have regular evaluations including clinical assessments and safety monitoring to track how the treatment affects their condition and to watch for any side effects or adverse events over the total duration of the study.

Researchers are evaluating the safety and effects of different doses of a new medicine called NNC0519-0130 on kidney function in adults with chronic kidney disease, some of whom may also have type 2 diabetes, and who are living with overweight or obesity. The study compares NNC0519-0130 with semaglutide, an existing medicine, and a placebo, which is a "dummy" treatment. This is a Phase 2 proof-of-concept and dose-finding study aimed at understanding how these treatments may reduce kidney damage. Participants will be randomly assigned to one of three groups receiving either NNC0519-0130, semaglutide, or placebo. All treatments are given by subcutaneous injection once weekly. The study treatment phase lasts up to 36 weeks, with assessments at weeks 12, 24, and 36 to monitor changes in kidney damage by measuring the urinary albumin-to-creatinine ratio. The overall study duration can be up to 43 weeks. During the study, participants will be regularly monitored through laboratory tests and clinical evaluations to assess kidney function and safety. Researchers will measure changes from the start of the study in the urinary albumin-to-creatinine ratio at multiple time points. Participants will also need to have stable doses of certain blood pressure medications before joining. Safety and treatment effects will be assessed throughout the study period.

Researchers are evaluating the effect and safety of different doses of a new medicine called NNC0662-0419 in people living with type 2 diabetes. This study compares NNC0662-0419 to a placebo or to semaglutide, an approved medication for type 2 diabetes. The goal is to determine if NNC0662-0419 is effective and safe for treating this condition in a phase 2 dose-finding study. Participants will receive one of the three treatments: NNC0662-0419, semaglutide, or placebo, all given by weekly subcutaneous injections. The treatment assignment is randomized, meaning participants are assigned to their group by chance. The study tests different doses of NNC0662-0419 to find the best dose for treating type 2 diabetes. During the study, researchers will monitor changes in participants' blood sugar levels by measuring glycated haemoglobin (HbA1c) at weeks 16, 28, and 40 compared to the start of the study. Participants will be regularly assessed for safety and treatment effects. The study includes adults aged 18 to 75 years and tracks the impact of the treatments over several months.

Researchers are investigating whether ziltivekimab can treat people living with heart failure and inflammation. The study compares ziltivekimab, a new medicine not yet approved anywhere, to a placebo, an inactive substance that looks like the medicine but contains no active drug. Participants have an equal chance of receiving either treatment. The study is expected to last up to one year and four months and focuses on people with heart failure who also have systemic inflammation. Participants will receive either ziltivekimab or placebo by monthly injections under the skin. The doses are given once a month throughout the study period. The study lasts for 12 months of treatment following randomization, during which the effects of the medicine compared to placebo will be closely monitored. During the study, participants will undergo various assessments including a heart failure questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure symptoms and physical function over the 12 months. Other evaluations may include walking tests and heart function tests. Safety and health will be monitored regularly to understand how participants respond to the treatments and to track any side effects or changes in heart failure symptoms.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

This trial investigates whether eptinezumab can reduce the number of migraine days in children and teenagers aged 6 to 17 with episodic migraine. The study focuses on pediatric participants who have had migraine headaches for at least six months, aiming to evaluate the preventive treatment potential of this medication. This is a Phase 3 randomized, double-blind, placebo-controlled study designed to assess both the effectiveness and safety of eptinezumab given intravenously. Participants will receive either eptinezumab or a placebo, both administered as a solution through an infusion. The study includes a screening period where migraine and headache frequency are recorded using an electronic diary. The main measurement is the change from baseline in the average number of monthly migraine days over the first 12 weeks of treatment. During the study, participants and their caregivers will complete headache diaries to track migraine occurrences. Researchers will monitor migraine frequency and evaluate safety throughout the trial. The primary outcome is the difference in migraine days per month compared to the start of the study, assessed over the 12-week treatment period. This study helps understand how well eptinezumab may prevent episodic migraine in the pediatric population.

Researchers are evaluating the safety and effectiveness of the study drug IPN10200 compared with a placebo for treating adults with Cervical Dystonia (CD). CD causes abnormal movements and symptoms in the head and neck, including pain, stiffness, and headaches. The condition may be influenced by brain function, genetics, and environmental factors. Current treatments involve botulinum toxin (BoNT) injections lasting about three months, but IPN10200 is designed to provide longer-lasting relief. Participants will receive a single intramuscular injection of IPN10200 at one of several doses or a placebo on the first day of the 36-week treatment period. The injections will be given into muscles in the head, neck, and shoulders. Before treatment, there is a screening period lasting up to four weeks to confirm eligibility. Some participants may continue other medications during the study, with all treatments recorded. The study involves about 40 weeks of participation, including screening and treatment. Participants will attend 10 to 12 in-person clinic visits plus one remote phone visit. During these visits, they will undergo blood and urine tests, physical and neurological exams, and clinical assessments. Questionnaires will also be completed to evaluate symptoms and treatment effects. The main outcome measured is the change in cervical dystonia severity four weeks after treatment based on a standardized rating scale.