Ostrowiec Swietokrzyski

Researchers are evaluating the long-term safety and effectiveness of abrocitinib, given as a liquid oral suspension, in children aged 2 years and older with moderate-to-severe atopic dermatitis. This Phase 3, open-label study includes children who have previously participated in abrocitinib studies as well as those who have not. The goal is to study up to 500 children globally over a period of up to 2 years or until the medicine becomes commercially available. Participants will receive abrocitinib oral suspension, with or without topical medications, throughout the study. The study consists of two groups: an extension group of children aged 2 to under 12 years who completed prior abrocitinib studies, and a de novo group of children aged 6 to under 12 years new to abrocitinib treatment. Both groups will be monitored for up to 24 months. During the study, children will be regularly assessed through evaluations, including monitoring for any adverse events, laboratory tests, and clinical examinations. Researchers will track treatment-emergent adverse events, serious adverse events, and any events leading to study discontinuation. Safety and efficacy will be closely followed throughout the entire study period to understand the long-term effects of abrocitinib in this population.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the safety and side effects of LY4005130 in adults with non-segmental vitiligo (NSV). This Phase 2 study compares LY4005130 with a placebo to understand how well the drug is tolerated. Participants have NSV affecting certain areas of their body and face, with the condition being either active or stable for at least 3 months. Participants will receive LY4005130 or a placebo through an intravenous (IV) infusion into a vein in the arm. The treatment phase lasts 24 weeks, during which the effects and safety of the drug will be monitored. The entire study, including screening, will take about 48 weeks. Throughout the study, participants will undergo blood tests to assess how their body processes the drug and how the drug affects their body. Researchers will measure the percentage of participants achieving significant improvement in facial vitiligo after 24 weeks. Safety and side effects will be followed carefully during treatment and the study period.

Researchers are evaluating how well LY4005130 works in adults with severe alopecia areata, a condition causing significant hair loss. This Phase 2 study compares LY4005130 with a placebo to assess its effectiveness, safety, and side effects. Blood tests will be conducted to understand how the body processes the drug and how the drug affects the body. The study drug, LY4005130, and placebo are both given intravenously into a vein in the arm. The treatment period includes administration of these study drugs under controlled conditions. The study lasts about 48 weeks in total, which includes a screening period before treatment. Participants will be involved in various assessments such as blood tests and evaluations of hair loss severity using the Severity of Alopecia Tool (SALT). The main outcome measured is the percentage of participants who achieve a SALT score of 20 or less by week 24. Safety and tolerability will be monitored throughout the study, with follow-up visits scheduled during the 48-week period.

Researchers are evaluating the safety and effectiveness of NT 201, a botulinum toxin drug, compared with a placebo in adults who have moderate to severe platysma prominence, which involves prominent neck bands. This Phase 3 study is conducted in Europe and focuses on improving the appearance of these neck muscles. The study aims to see how well NT 201 works and how safe it is for participants with this condition. Participants will receive either NT 201 or a matching placebo injection, which contains Clostridium Botulinum neurotoxin A without complexing proteins. The study has two parts: the Main Period (MP), where the initial treatment is given and evaluated, and an Open Label Extension Period (OLEX) that follows. The effectiveness is primarily measured by improvement on the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D) at two weeks after treatment. During the study, participants will be assessed by both investigators and themselves for platysma band severity and improvement. Safety and treatment outcomes will be monitored throughout the study periods. The total involvement includes screening, treatment, and follow-up assessments to observe the drug's impact and any side effects over time.

This research aims to evaluate the antiviral effects of S-337395 compared with placebo in nonhospitalized adult participants who have symptomatic respiratory syncytial virus (RSV) infection and are at high risk of progressing to severe disease. The study focuses on adults with recent onset of RSV symptoms and important risk factors such as advanced age or chronic lung or cardiovascular disease. It is designed as a Phase 2b, randomized, double-blind, placebo-controlled trial to assess safety, tolerability, and efficacy. Participants will receive either S-337395 or a matching placebo according to a specified dosing schedule. The treatment begins within 72 hours of RSV symptom onset. The study measures changes in RSV viral RNA load from baseline to Days 2, 4, and 6 using nasopharyngeal swabs and quantitative reverse transcription polymerase chain reaction (qRT-PCR) tests to monitor antiviral effects. During the study, participants will be monitored for safety and effectiveness through viral load testing at multiple time points. Medical history, physical exams, vital signs, and ECGs are conducted to ensure stability aside from RSV symptoms. The study also tracks symptoms and any adverse events to evaluate treatment tolerability. Total participation includes screening and follow-up assessments as outlined by the study protocol.

Researchers are evaluating the medicine called abrocitinib in children aged 6 to less than 12 years old with moderate-to-severe eczema. This phase 3 study aims to find out if abrocitinib improves eczema symptoms and is safe for this age group. Participants will be randomly assigned to receive either abrocitinib or a placebo for 16 weeks, with the total study lasting about 24 weeks. Participants will receive abrocitinib or placebo as a liquid oral suspension. During the study, children will use an electronic diary on a device resembling a cell phone to record questionnaire responses and receive daily reminders to take their medicine. They will also wear a wrist device to monitor scratching due to eczema. The study includes regular clinic visits and calls from study staff to monitor progress and adherence. Throughout the study, laboratory tests, physical exams, and vital signs (height, weight, temperature, blood pressure, and heart rate) will be conducted to monitor health. Questionnaires will assess eczema severity and improvement using standardized scales. The main outcomes measured at week 12 include skin clearance or near clearance and at least 75% improvement in eczema severity. Safety and overall health will be followed for the entire study duration.

Researchers are evaluating the effectiveness and safety of ruxolitinib cream in children aged 6 to under 12 years with nonsegmental vitiligo, a condition causing skin depigmentation. This phase 3 study focuses on children who have vitiligo affecting specific body areas, including the face and other parts, with certain minimum involvement percentages required for enrollment. Participants will be randomly assigned to receive either ruxolitinib cream or a matching vehicle cream, both applied topically as a thin film twice daily to affected areas. The study is double-blinded, meaning neither the participants nor the researchers know who receives which cream. Treatment will continue with regular assessments to monitor progress and safety. During the study, children will have their vitiligo area measured using the Facial Vitiligo Area Scoring Index (F-VASI) to assess improvement, with the main goal being at least a 75% improvement by week 24. Participants must stop all other vitiligo treatments during the study and will be closely monitored for safety and adherence through scheduled visits and evaluations. The total body vitiligo area must be 10% or less for participation.

Researchers are evaluating the effects of three different dosing schedules of povorcitinib on lung function in adults with moderately to severely uncontrolled asthma. This Phase 2, randomized, double-blind, placebo-controlled study aims to assess both the safety and efficacy of povorcitinib in improving respiratory outcomes for this patient group. Participants have a history of asthma treatment with medium- to high-dose ICS-LABA therapy and meet specific lung function criteria before enrollment. Participants will receive one of three povorcitinib dosing regimens or a placebo while continuing their background ICS-LABA therapy. The study includes multiple treatment arms to compare the effects of different doses. The intervention period lasts 24 weeks, during which pulmonary function and other health measures will be monitored. During the study, participants will undergo regular assessments, including lung function tests measuring pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1) at baseline and week 24. Researchers will also monitor safety and collect data on asthma exacerbations and symptom control. The total participation time covers the treatment duration and follow-up evaluations to assess changes in pulmonary function and overall health status.

This research aims to evaluate the impact of dupilumab compared to placebo on airway inflammation, airway resistance, and airway remodeling in people aged 40 to 85 years with chronic obstructive pulmonary disease (COPD). The study focuses particularly on mucus plugging and how it relates to lung function, exacerbations, and quality of life improvements. This is a multinational, randomized, double-blind, placebo-controlled Phase 4 study with two treatment groups. Participants will receive either dupilumab or a placebo, both given as subcutaneous injections. The treatment period lasts up to 24 weeks, within a total study duration of up to 40 weeks. The study includes 9 visits throughout this time to monitor progress and safety. During participation, researchers will assess lung mucus using imaging scores from baseline through Week 24 to measure changes. Other evaluations include lung function tests, monitoring exacerbations, and quality of life measures. Safety and effectiveness will be carefully tracked through these visits, with ongoing assessments to understand the treatment impact over the study period.