Vienna

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC) in this 26-week phase 3 study. The study is randomized, double-blind, and placebo-controlled, involving multiple centers. It aims to compare three doses of tenapanor (5 mg, 25 mg, and 50 mg taken twice daily) against a placebo, with a focus on improving spontaneous bowel movements. Participants will first undergo a 2-week screening where their eligibility is assessed through medical history, physical exams, lab tests, ECG, and self-reported constipation symptoms using an electronic diary (eDiary). Eligible patients will then be randomly assigned to receive one of the three doses of tenapanor or placebo twice daily for 26 weeks. During this treatment period, patients will continue daily and weekly symptom reporting via the eDiary and attend regular safety visits at weeks 2, 4, 8, 12, 16, 20, and 26. After completing the 26-week treatment, patients enter a 4-week treatment-free safety follow-up period to monitor any adverse events. A final visit occurs at the end of this follow-up to assess safety. The main outcome measured is the durable complete spontaneous bowel movements response over 12 weeks. Overall, the study involves careful monitoring of symptoms, safety, and treatment effects over approximately 32 weeks.

Researchers are evaluating the effectiveness, safety, and tolerability of two different doses of remibrutinib compared to a placebo in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). This phase 3 study aims to determine how well remibrutinib works in treating this chronic skin condition characterized by painful abscesses and inflammatory nodules. The study lasts a total of 76 weeks and includes several phases: up to 4 weeks for screening, followed by a 16-week double-blind treatment period where participants receive either remibrutinib Dose A, Dose B, or a matching placebo. After this, there is a 52-week treatment period where all participants receive remibrutinib (Dose A or Dose B). Finally, a 4-week safety follow-up period occurs without treatment. Participants who stop treatment early are encouraged to stay in the study and complete the safety follow-up. During the study, participants will be regularly assessed for clinical response to treatment, focusing on the proportion achieving a 50% improvement in HS symptoms by week 16. Researchers will monitor safety and tolerability throughout the study, including during the follow-up period. Various evaluations such as physical exams and clinical assessments will be conducted to measure treatment effects and ensure participant safety over the entire 76-week duration.

This trial investigates the clinical benefits of finerenone compared to a fixed-dose combination of extended-release torsemide and spironolactone in adults with hypertension and chronic kidney disease. It is a randomized, parallel, two-arm Phase 3 study focusing on patients with proteinuric chronic kidney disease and hypertension, aiming to evaluate net clinical benefit through several measures. Participants receive either finerenone with stabilized doses of loop diuretics or a fixed-dose combination of spironolactone and extended-release torsemide. The usual starting dose of torsemide ranges from 5-10 mg for hypertension, with an initial 25 mg daily dose for heart failure or hypertension treatment. Treatment includes up to 80 mg furosemide or equivalent loop diuretics alongside 10 mg finerenone daily, with comparisons made between these regimens. During the study, researchers will monitor systolic blood pressure, urine albumin-to-creatinine ratio, and serum potassium levels over 12 weeks to assess net clinical benefit. Participants must comply with study procedures, including providing informed consent and using contraception if applicable. Safety and clinical outcomes will be evaluated throughout the treatment period to understand the impact of these therapies on hypertension and chronic kidney disease.

This research aims to understand the safety, effectiveness, and overall treatment experience of participants prescribed BRIUMVI4 (ublituximab-xiiy) in a real-world setting. The study focuses on people living with relapsing multiple sclerosis (RMS), a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms. It is designed to gather detailed insights from actual use outside of controlled clinical trials. Participants in this study are those who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. There is no intervention assigned by the study itself; instead, it observes the outcomes and experiences of patients treated with BRIUMVI4 as part of their routine care over time. Throughout the study, researchers will track the annualized relapse rate (ARR) up to week 96 to measure disease activity. Participants' safety, treatment adherence, and experiences will be evaluated through regular monitoring, including any adverse events. The total duration of participation covers up to 96 weeks, allowing for a comprehensive understanding of long-term treatment effects and patient-reported outcomes.

Researchers are evaluating whether the drug RTN-001 can reduce high blood pressure in adults with uncontrolled hypertension. This Phase 2b study involves patients aged 18 to 70 who have high blood pressure despite taking at least two antihypertensive medications. The trial aims to compare the effects and safety of RTN-001 against a placebo to understand its impact on blood pressure and possible side effects. The study includes three main periods: Screening, Run-in, and Treatment. After screening and a 14-day Run-in period to check patient compliance and baseline blood pressure, about 280 patients will be randomly assigned to receive daily doses of RTN-001 at 15, 30, or 45 mg or a matching placebo for 12 weeks. Blood pressure and laboratory tests will be taken regularly throughout the treatment period, with additional ambulatory blood pressure monitoring around weeks 4 and 12. A safety review is planned after about 25% of participants reach week 2, and a follow-up phone call occurs two weeks after treatment ends to check for adverse events. Participants will visit the clinic about every two weeks for checkups, blood sampling, and blood pressure measurements. They will keep a diary of symptoms and medications. Researchers will assess changes in systolic blood pressure as the main outcome and monitor safety through laboratory tests and adverse event reports. The total study duration for each participant includes screening, treatment, and a follow-up period lasting approximately 14 weeks in total.

Researchers are evaluating the effectiveness of remibrutinib compared to dupilumab in adults with moderate to severe chronic spontaneous urticaria (CSU) that is not adequately controlled by second generation H1-antihistamines (sgH1-AHs). This Phase 3b, multi-center, randomized, double-blind, double-dummy study is conducted in the US and focuses on early treatment effects at 4 weeks and earlier. The study includes a screening period of up to 4 weeks, followed by a 12-week core treatment period where about 400 participants are randomly assigned to receive either remibrutinib (25 mg twice daily by mouth) with a placebo injection or dupilumab (a 600 mg loading dose followed by 300 mg every 2 weeks by injection) with a placebo tablet. All participants continue their stable dose of sgH1-AH during this period, with the option to add rescue doses if needed, not exceeding four times the standard dose per day. After the core period, participants may join an optional open-label extension to receive remibrutinib for an additional 12 weeks if the drug is not commercially available. Participants will complete daily diaries and regular assessments to track urticaria symptoms and treatment effects. Researchers will measure changes in the Weekly Urticaria Activity Score (UAS7) from the start to Week 4. Safety follow-up will occur for 12 weeks after treatment ends, with phone calls and site visits as needed, continuing longer if participants join the extension. The total study duration includes screening, treatment, optional extension, and safety follow-up phases.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 who have mild to severe Alzheimer's Disease (AD) accompanied by moderate to severe psychosis related to AD. This phase 3 study aims to better understand how KarXT compares to a placebo in treating the psychotic symptoms associated with Alzheimer's Disease. Participants must have documented AD diagnosis and a history of psychotic symptoms lasting at least two months prior to starting the study. Participants will receive either KarXT or a placebo, with specified doses given on designated days. The study is designed as a randomized, double-blind, placebo-controlled trial with parallel groups to assess the treatment's effects. Details about dosing schedules and administration are planned but not specified here. During the study, researchers will measure changes from baseline in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score up to week 14 to evaluate the impact on psychosis symptoms. Participants will undergo brain imaging (MRI or CT) if not already done within the past five years to rule out other conditions, and safety monitoring including laboratory tests will be conducted. The total participation duration covers screening through at least 14 weeks of treatment and assessment.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of CK-4021586 in adults aged 40 to 85 years with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF). This Phase 2 dose-finding study focuses on participants who have NYHA functional class II or III heart failure and a left ventricular ejection fraction (LVEF) of 60% or higher. The study aims to gather important data on the drug's effects and safety profile in this specific heart condition. Participants will receive either oral CK-4021586 at doses of 150 mg, 300 mg, 450 mg, or 600 mg, or a matching placebo. Stable doses of background medications such as beta-blockers, ACE inhibitors, ARBs, or ARNIs are required before the study, as well as stable use of GLP-1 agonists if applicable. The study is randomized, double-blind, and placebo-controlled, ensuring rigorous comparison between the investigational drug and placebo groups. During the 12-week study period, participants will be monitored for early drug discontinuation, heart function changes indicated by LVEF falling below 40%, and the occurrence of adverse events. Evaluations include echocardiography, laboratory tests for NT-proBNP levels, and ongoing safety assessments. This careful monitoring helps researchers understand the treatment's safety and tolerability in people with HFpEF over the study duration.

Researchers are evaluating the real-world effectiveness of nemolizumab in treating moderate-to-severe Prurigo Nodularis (PN) in adults. This non-interventional, prospective, multicenter study focuses on physician assessments and patient-reported outcomes over approximately 12 months in routine clinical settings. The study aims to measure improvements using both investigator and patient evaluations at Month 6. Treatment with nemolizumab (Nemluvio) is decided by the participant's physician before enrollment, with no additional visits or tests beyond usual care. Visit schedules follow standard medical practice rather than study requirements. A sub-study in Germany and the UK involves daily remote completion of Peak Pruritus Numerical Rating Scale (PP NRS) and Sleep Disturbance NRS from Day -1 to Day 14 without clinic visits. Participants will be involved in routine clinical visits where physician assessments and patient-reported outcomes are collected. The main outcomes measured include the Investigator Global Assessment of chronic Prurigo (IGA-CPG stage) and Peak Pruritus Numerical Rating Scale at 6 months. Data collection relies on standard practice, with no extra procedures, and monitoring occurs throughout the study duration of about one year.

Researchers are evaluating the real-world effectiveness of nemolizumab for treating moderate-to-severe atopic dermatitis (AD) in adolescents and adults. This study is a prospective, multicenter, non-interventional trial that aims to measure treatment outcomes through physician assessments and patient-reported outcomes over approximately 12 months. The goal is to understand how nemolizumab works in routine clinical practice, focusing on physician evaluations and patient experiences at Month 6. Treatment with nemolizumab is determined solely by the participant's physician before joining the study, with no extra visits, procedures, or lab tests beyond standard care. The study does not define a specific visit schedule; instead, visits follow routine medical practice to collect data systematically. A sub-study in Germany and the UK will have participants complete daily questionnaires on itch severity, sleep disturbance, and pain from Day -1 to Day 14 remotely, without requiring clinic visits. Participants will be involved in routine clinical visits where physician assessments and patient-reported outcome measures will be gathered. Key outcomes measured include the Investigator Global Assessment (IGA) and the Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6. The study observes participant responses and safety under normal care conditions, with data collection lasting about a year to evaluate nemolizumab's effectiveness in everyday treatment settings.