Sevlievo

Researchers are evaluating the dose-response relationship of galvokimig compared with placebo in adults with moderate-to-severe atopic dermatitis AtD. The study focuses on participants who have had chronic AtD for at least one year and aims to assess how different doses of galvokimig impact the condition. This phase 2 trial is designed to better understand the drugs effects on symptoms and safety in this population. Participants are randomly assigned to one of several groups receiving different predefined doses of galvokimig or a matching placebo during an initial 16-week intervention period. After week 16, participants continue treatment with the same or a modified dose of galvokimig. The study uses a double-blind design to compare the effects of these doses on atopic dermatitis. During the study, participants will undergo regular assessments including the Eczema Area and Severity Index EASI, Investigator Global Assessment vIGA, and Peak Pruritus Numerical Rating Scale PP-NRS. Safety is monitored through reported adverse events up to week 58. The primary outcome is the percentage of participants achieving a significant improvement in EASI score at week 16. The total study duration extends beyond 16 weeks to include ongoing safety and response evaluations.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the safety of an investigational varicella vaccine VNS Vaccine compared to an approved varicella vaccine called Varivax. This study focuses on healthy children aged 12 to 15 months who have not had chickenpox or received any varicella vaccine before. The goal is to understand how well the new vaccine is tolerated in this young population. Participants will receive one dose of either the investigational varicella vaccine or the marketed Varivax vaccine, both given by injection under the skin. Along with the varicella vaccine, each child will also receive one dose each of measles, mumps, and rubella MMR vaccine, hepatitis A vaccine, and a pneumococcal conjugate vaccine PCV, which may be PCV 13, Vaxneuvance, or PCV 20, depending on availability and national recommendations. All vaccines are given on the first day of the study. During the study, parents will record any side effects their child experiences, particularly those related to the injection site or systemic symptoms like fever, for up to 43 days. Researchers will monitor any adverse events, including serious and medically attended events, for up to 181 days after vaccination. This helps assess the safety and tolerability of the investigational vaccine over a period of about six months.

Researchers are studying children aged 6 to less than 12 years with asthma to compare the effects and safety of QMF149 a combination of indacaterol acetate and mometasone furoate with budesonide. This Phase 3, double-blind, randomized, two-period, crossover study aims to determine if QMF149 is superior to budesonide in improving lung function and asthma control in this pediatric population. Participants undergo a total study duration of up to 37 weeks, including screening and run-in periods, two 12-week treatment phases where they receive either QMF149 7540 mcg once daily or budesonide 200 mcg once daily via Breezhaler, separated by a 3-week washout period with fluticasone propionate. Following treatment periods, a 4-week safety follow-up occurs during which patients return to standard care. Throughout the study, children and their parentslegal guardians attend scheduled visits for assessments including lung function tests FEV1, asthma control questionnaires, peak expiratory flow rate measurements, and rescue medication use tracking. Safety is monitored by recording adverse events up to 30 days after the last dose. The study evaluates changes from baseline in lung function and asthma control after each treatment period, with participants supported in completing diaries and attending visits over the 37-week timeline.

Researchers are studying the use of ruxolitinib cream in children aged 6 to under 12 years who have nonsegmental vitiligo. The study aims to evaluate how well and how safely the cream works for treating this condition, which causes loss of skin color. This is a Phase 3 clinical trial focused on treatment effects in this pediatric population. Participants are assigned to one of three groups receiving either ruxolitinib cream at 0.75% or 1.5%, or a matching vehicle placebo cream. Each cream is applied topically as a thin film twice daily to the affected skin areas as defined in the study protocol. The treatment period lasts up to 24 weeks, during which changes in skin pigmentation are monitored. Throughout the study, participants undergo regular assessments including evaluations of vitiligo improvement on the face and body using the Vitiligo Area Scoring Index and other scales. Safety is monitored by tracking adverse events and blood levels of the drug at multiple timepoints up to 52 weeks. Quality of life and psychosocial effects are also measured. The total study duration includes treatment and follow-up visits to assess long-term outcomes and safety.

Researchers are evaluating ibuzatrelvir, an oral medication, to determine its effectiveness and safety in adults and adolescents aged 12 years and older with COVID-19 who are not hospitalized but are at high risk for severe illness. The study is a phase 3, randomized, double-blind trial comparing ibuzatrelvir with a placebo. Participants must have confirmed SARS-CoV-2 infection with symptoms starting within 5 days and meet specific risk factor criteria based on age. Eligible participants will be randomly assigned to receive either ibuzatrelvir or a matching placebo twice daily by mouth for 5 days. The study allows co-administration of standard care treatments available locally. The total study duration is about 6 months, including follow-up. Participants will be monitored for emergency department visits related to COVID-19, hospitalizations, and mortality up to 28 days after starting treatment. Additional evaluations include symptom resolution, occurrence of long COVID symptoms, viral RNA levels, and safety measures such as adverse events through 24 weeks. The study involves regular assessments, including clinical visits and laboratory tests, to track outcomes and safety over time.

Researchers are evaluating the safety, how the body processes, and how well the study medicine nirmatrelvirritonavir works for treating COVID-19 in children under 18 years old who are not hospitalized but at risk of severe illness. This trial is a Phase 3, open-label study focusing on nonhospitalized pediatric patients with COVID-19 to better understand the effects of this oral medication. The study medicine is given by mouth as tablets or powder twice daily for 5 days, totaling 10 doses. Different dosing forms and amounts are used depending on the participants age and weight, ranging from under 1 month old up to 18 years. Participants are assigned to one of several groups based on these factors to receive the medicine accordingly. During the study, participants will have blood samples taken to measure drug levels at specific times, and researchers will monitor for any side effects or changes in vital signs up to 34 days after starting treatment. They will also measure viral load through nasal swabs at several points over 28 days and assess hospitalizations or deaths related to COVID-19. Participants feedback on the medicines taste and acceptability will be collected during treatment.

The trial investigates the effects of two doses of inhaled glycopyrronium compared to placebo in children aged 6 to less than 12 years with moderate to severe asthma. The aim is to understand how glycopyrronium works in the body, its safety, and its impact on lung function. This information will guide the development of a combination asthma treatment including indacaterol, mometasone, and glycopyrronium for this age group. Participants will receive study treatments added to their regular asthma controller therapy, including salmeterol and fluticasone. The trial uses a double-blind, randomized crossover design where each child will receive glycopyrronium 12.5 g, glycopyrronium 25 g, and placebo in three separate two-week treatment periods. These periods are separated by two-week washout phases. The study includes four phases Screening, Run-in, Treatment, and Follow-up. During the study, lung function tests such as forced expiratory volume in one second FEV1 and peak expiratory flow PEF will be measured at the start and end of each treatment period. Pharmacokinetic blood samples will assess how the drug moves in the body. Safety will be monitored through adverse event tracking and electronic diaries completed by parents or guardians. The total participation time is approximately 20 weeks, including safety follow-up by phone 30 days after the last treatment.

This trial is a rollover study for adults who previously participated in specific Incyte-sponsored clinical trials involving the drug povorcitinib. It focuses on people with Hidradenitis Suppurativa HS, a condition being studied to better understand the long-term safety and effects of continuing povorcitinib treatment. The purpose is to monitor participants who have already benefited from povorcitinib in earlier studies, now entering an extended phase to further evaluate safety and treatment outcomes. Participants will continue taking povorcitinib orally, following the same dose and schedule they had in their original parent study. This study does not test new doses or compare treatments but observes continued use of the drug under the established regimen. The study may last for up to approximately three years, reflecting extended monitoring rather than initial treatment phases. During the study, participants will attend scheduled visits for assessments, including tracking any treatment-emergent adverse events and measuring symptom counts related to HS. Researchers will collect safety data over the long term and observe clinical responses. Participants must adhere to study procedures and avoid pregnancy or fathering children as required. The study aims to provide detailed safety information over an extended period while participants remain on the drug regimen from their original trial.