Darmstadt

Researchers are conducting a prospective observational study to examine asthma control, health-related quality of life HRQL, lung function, and asthma medication use in patients with severe eosinophilic asthma treated with benralizumab in routine clinical practice settings in Germany. The study aims to gather real-world evidence on these patients over a 52-week period. Participants will be treated with benralizumab as part of their standard care, and no additional treatment will be assigned by the study. Asthma control will be assessed using the Asthma Control Test ACT and the Asthma Impairment and Risk Questionnaire AIRQae at various timepoints. Health-related quality of life will be measured using the mini Asthma Quality of Life Questionnaire miniAQLQ at baseline and follow-up visits. Patients will record their weekly asthma medication intake using either paper or electronic diaries throughout the study. During the study, participants will attend routine follow-up visits where investigators will collect clinical assessments and questionnaire data. Researchers will monitor changes in asthma control, lung function parameters, medication use, and patient-reported outcomes up to 52 weeks after the first dose of benralizumab. The primary outcomes include changes in ACT scores and inhaled corticosteroid use, while secondary outcomes cover remission criteria, lung function, biomarkers, exacerbation rates, and quality of life measures.

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 effectiveness and safety of Corabotase IPN10200 in adults with moderate to severe glabellar lines, which are wrinkle-like lines between the eyebrows that may affect appearance and confidence. This Phase III study compares a single dose of Corabotase to a placebo in a double-blind phase, followed by an open-label phase to assess repeat doses over time. Participants will receive injections of Corabotase or placebo into selected facial muscles. The study includes a screening period of up to 20 days, a treatment period with up to four treatment cycles where participants may receive Corabotase or placebo in the double-blind phase and Corabotase in the open-label phase, and a follow-up period lasting 24 weeks after the last injection. Multiple visits occur during the first month of treatment, followed by monthly visits. During the study, participants will have health assessments including blood tests, physical exams, ECGs, questionnaires, and diaries. Researchers will measure treatment response at week 4 and monitor safety and satisfaction through week 104. Total participation lasts up to 107 weeks, and participants may withdraw at any time.

Researchers are evaluating AZD0292, a bispecific IgG1k monoclonal antibody, for preventing exacerbations in bronchiectasis patients who are chronically colonized with Pseudomonas aeruginosa PsA. This Phase IIb study compares two dosage regimens of AZD0292 administered intravenously with placebo in participants aged 12 years and older. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent pulmonary exacerbations due to chronic PsA colonization, which negatively affects lung function, quality of life, and survival. Additionally, patients with cystic fibrosis bronchiectasis colonized with PsA are included as an exploratory group. Participants will receive either high-dose or low-dose AZD0292 starting on Day 1 via IV infusion, or placebo administered similarly. Subsequent doses will follow a schedule of assessments. This randomized, double-blind, placebo-controlled, parallel study aims to assess the efficacy, safety, and pharmacokinetics of AZD0292 over a variable follow-up period ranging from a minimum of 28 weeks up to 52 weeks. The trial also includes monitoring for adverse events and immune responses to the treatment. During the study, participants will undergo evaluations including lung function tests, quality of life questionnaires, and monitoring of exacerbation rates. Blood samples will be collected to measure drug concentration and antibody development. Safety assessments will continue through the treatment period and for up to 24 weeks after the last dose. The primary outcome is the annualized rate of exacerbations over the follow-up time, and secondary measures include severe exacerbation rates, time to first exacerbation, and changes in quality of life scores. Total participation spans from screening through the treatment and follow-up phases.

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

Researchers are evaluating SAR445399 in adults with moderate to severe hidradenitis suppurativa, a chronic skin condition. This Phase 2, multinational, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of two different doses of SAR445399 compared to placebo. The study is sponsored by Sanofi and involves adult participants who have had symptoms for at least six months and meet specific severity criteria. Participants will be randomly assigned to receive one of two SAR445399 dose regimens or a matching placebo. The study involves a 32-week treatment period, which is divided into a 16-week initial double-blind phase followed by a 16-week treatment-blinded extension phase. SAR445399 and placebo are given by injection. The trial includes a total of 16 visits over approximately 46 weeks. During the study, participants will undergo regular assessments to measure skin improvement, pain levels, quality of life, and safety. Researchers will monitor clinical responses using standardized scales such as the Hidradenitis Suppurativa Clinical Response HiSCR and other quality of life questionnaires. Laboratory tests, vital signs, and ECGs will also be performed. Safety will be tracked throughout the treatment and extension periods, with follow-up visits included in the 46-week study duration.

Researchers are evaluating the activity and safety of barzolvolimab compared to placebo in adults with cold induced urticaria or symptomatic dermographism who continue to have symptoms despite using H1-antihistamines. This Phase 3, randomized, double-blind, placebo-controlled trial aims to understand how barzolvolimab works in these conditions that cause hives and itching triggered by cold or skin friction. Participants will first go through a screening period of up to 4 weeks to confirm eligibility. The treatment period lasts 52 weeks and has two parts for the first 24 weeks, patients receive either barzolvolimab or placebo by subcutaneous injection every 4 weeks, with an initial barzolvolimab dose of 450mg followed by 150mg doses. For the next 28 weeks, all patients receive 300mg barzolvolimab every 8 weeks. After treatment, there is a 16-week follow-up period during which participants are observed without receiving study drug. During the study, participants will have provocation testing to measure responses at various time points, including weeks 4, 12, and 24. Researchers will assess symptoms like itch and hives and measure thresholds related to cold and friction triggers. Participants will complete daily symptom diaries and attend regular visits for safety monitoring and assessments. The main outcome is a complete response to provocation testing at week 12. Overall participation lasts about 1 year including screening, treatment, and follow-up.

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

Transthyretin amyloid cardiomyopathy ATTR-CM is a condition where a protein called transthyretin TTR breaks down and forms harmful clumps called amyloid, which deposit in the heart wall and impair its ability to pump blood properly. This can lead to heart failure and may be caused by age-related changes or genetic factors. Researchers are studying acoramidis, a drug that attaches to TTR to stabilize it and reduce amyloid formation, in participants who were previously treated with tafamidis, another TTR stabilizer. The goal is to see if switching to acoramidis increases blood TTR levels beyond those achieved with tafamidis. Participants will take acoramidis as two 356 mg tablets twice daily by mouth for up to 6 months. Before starting, all participants will continue their tafamidis treatment during a screening period. The study involves a single treatment group receiving acoramidis, and the main measurement is the change in serum TTR levels from baseline to 6 months or earlier if treatment stops. Secondary measures include heart function markers, kidney and thyroid assessments, and quality of life scores. Participants will be involved in nine check-ins, including two visits at the study site at screening and the end of treatment, six home visits by a study nurse during the first month and at 3 months, and a final phone check-in. Assessments include electrocardiograms, blood pressure, heart rate, and collection of blood and urine samples to monitor various health markers. The total participation time is about 8 months, during which researchers will monitor safety and treatment effects closely.

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 with moderate to severe chronic obstructive pulmonary disease COPD who have type 2 inflammation and uncontrolled symptoms despite standard care. The study aims to assess the safety and effectiveness of depemokimab compared to a placebo when added to the usual treatment. This phase 3 trial is sponsored by GlaxoSmithKline and focuses on reducing COPD exacerbations and improving respiratory symptoms over a long period. Participants will receive either depemokimab by subcutaneous injection alongside their standard inhaler therapy or a placebo injection plus standard care. The study is randomized, double-blind, and includes two groups one receiving depemokimab and the other a placebo, both continuing optimized inhaler treatments. This study will last up to 104 weeks, with regular assessments throughout. During the study, participants will undergo evaluations including lung function tests, symptom questionnaires such as the COPD assessment test and St. Georges Respiratory Questionnaire, and monitoring for COPD flare-ups or hospital visits. Researchers will track the number and severity of exacerbations and changes in quality of life measures. Safety and tolerability will also be closely monitored throughout the trial duration, which extends up to two years.