Blagoevgrad

Researchers are evaluating the effect of vipoglanstat on reducing non-menstrual pelvic pain related to endometriosis in women. This phase 2 trial focuses on women who have moderate to severe pain caused by endometriosis, aiming to see how well vipoglanstat works compared to a placebo. The study is designed to measure changes in pain over a period of about four months. Participants in this trial will receive either vipoglanstat capsules or matching placebo capsules taken orally for approximately four menstrual cycles during the treatment period. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active drug or placebo until the study ends. Two different doses of vipoglanstat are being tested to assess safety and effectiveness. During the study, women will be monitored for changes in their endometriosis-related non-menstrual pelvic pain, with the primary measure being the percentage of participants who meet a specific pain response criterion from the start of the study to the fourth month of treatment. The trial includes careful tracking of symptoms and safety over the treatment duration to evaluate how well vipoglanstat manages pain in this population.

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 the effectiveness, safety, and tolerability of ITI-1284 compared to a placebo in treating psychosis associated with Alzheimer's disease. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study focuses on patients aged 55 and older who meet specific clinical criteria for Alzheimer's disease and psychosis. The study aims to assess changes in psychosis symptoms using the BEHAVE-AD psychosis subscale score after 6 weeks of treatment. Participants will be randomly assigned in equal numbers to receive either ITI-1284 or a placebo. ITI-1284 is administered as a rapidly disintegrating tablet taken once daily under the tongue at doses of 10 mg or 20 mg. The study includes three periods: up to 4 weeks of screening to determine eligibility, a 6-week double-blind treatment phase where participants receive their assigned medication, and a 30-day safety follow-up after the last dose to monitor any adverse effects. During the study, participants will undergo assessments to confirm Alzheimer's disease diagnosis and psychosis presence, including biomarker tests, clinical rating scales, and cognitive evaluations. Caregivers will be involved as designated support persons. Researchers will monitor symptom changes, safety, and tolerability throughout the treatment and follow-up periods. The primary outcome is the psychosis subscale score measured at week 6, with safety follow-up visits approximately 30 days after treatment ends.

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are investigating the safety, tolerability, and effectiveness of XEN1101 as an additional treatment for people with primary generalized tonic-clonic seizures (PGTCS) who have generalized epilepsy and are already taking 1 to 3 anti-seizure medications. This phase 3, multicenter, randomized, double-blind, placebo-controlled study includes participants aged 12 years and older and aims to better understand how XEN1101 affects seizure frequency compared to placebo. Participants will be randomly assigned to receive either XEN1101 or a placebo capsule once daily with their evening meal during a 12-week double-blind treatment period. Those aged 18 and older will take a 25 mg dose of XEN1101 or placebo, while those aged 12 to under 18 may receive 15 mg, 25 mg, or placebo. Before this period, participants will have up to 9.5 weeks to record their baseline seizure frequency. After completing the double-blind period, participants can join an open-label extension study for continued XEN1101 treatment or enter an 8-week follow-up phase if they do not enroll in the extension. During the study, participants will keep detailed seizure diaries and maintain stable doses of their anti-seizure medications. Researchers will monitor seizure frequency changes, safety, and tolerability throughout the treatment. The main measurement is the median percent change in monthly primary generalized tonic-clonic seizure frequency from baseline through the 12-week treatment. Safety follow-up and monitoring will continue during the post-treatment follow-up or open-label extension periods, with total participation lasting several months depending on extension enrollment.

This research aims to evaluate the safety and effects of the study medicine PF-07328948 for adults with heart failure. It focuses on how this medicine works compared to a placebo in people who are already using standard heart failure treatments that include sodium-glucose cotransporter 2 (SGLT2) inhibitors. The trial is a Phase 2 study designed to better understand if PF-07328948 is safe and effective for managing heart failure symptoms and improving patients' health. Participants will be randomly assigned to receive either placebo tablets or one of three doses of PF-07328948 (low, medium, or high dose). All medications are taken once daily by mouth for 36 weeks. The treatment period is followed by ongoing study visits to monitor participants. The study involves 15 visits over about 48 weeks, with 10 visits at the study site and 5 visits conducted remotely by phone. During the study, researchers will assess participants at the start and after 36 weeks by measuring clinical events, changes in the six-minute walk test distance, and changes in heart failure symptoms using the Kansas City Cardiomyopathy Questionnaire. Safety and treatment effects will be closely monitored through these visits and assessments throughout the study period.

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

Researchers are evaluating the effectiveness of riliprubart compared to a placebo in adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) whose disease has not responded to standard treatments. This is a Phase 3, double-blind, placebo-controlled study focusing on participants with refractory CIDP, including typical and variant forms such as motor CIDP and multifocal CIDP. The study aims to assess response rates over time to better understand the potential benefits and safety of riliprubart for this condition. Participants will receive either riliprubart or placebo administered as a solution via intravenous infusion or subcutaneous injection. The treatment period includes multiple phases with dosing and monitoring planned through 48 weeks. The study includes a screening phase, treatment phases, and follow-up extending up to a total of 111 weeks. Both groups will be monitored for lasting treatment responses, with specific attention to changes from baseline to weeks 24 and 48. During the study, participants will undergo regular assessments to track their disease activity and response to treatment. Evaluations include clinical scoring using the INCAT and CIDP disease activity scores, documentation of vaccinations, and monitoring for adverse effects. Researchers will measure the percentage of participants showing a treatment response and those maintaining that response over time, while also ensuring participant safety through ongoing follow-up and clinical evaluations throughout the study duration.