Mandeville

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.

This research aims to evaluate the effectiveness and safety of BFB759 in adults with moderate to severe hidradenitis suppurativa, a chronic inflammatory skin condition. The study is a Phase 2 and Phase 3, dose-ranging, randomized, double-blind, placebo-controlled trial comparing BFB759, a biological treatment that blocks multiple pro-inflammatory cytokines, to a placebo. Participants have had hidradenitis suppurativa for at least one year and have disease that is not well controlled by antibiotics. Participants receive either BFB759 or a placebo in a blinded manner over the course of the study. The study lasts approximately 36 to 40 weeks during which the treatment's effects and safety are assessed. The trial evaluates the drug's impact on hidradenitis suppurativa symptoms and monitors for any adverse reactions. Throughout the study, participants attend regular visits to assess their condition and safety. Researchers monitor the efficacy of BFB759 from the start to Week 16 and Week 32. Participants are asked to follow study instructions carefully, attend scheduled visits, and avoid certain other medications. The trial includes adults aged 18 to 75 years and collects data on treatment effectiveness and safety over the full study period.

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

This multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease. The study includes three sub-studies focusing on induction treatment, with specific co-primary endpoints assessing clinical remission and endoscopic response at 12 weeks. Participants will receive either duvakitug or a placebo via subcutaneous injection during the treatment periods. The study duration can last up to 35 weeks and consists of a screening period of up to 5 weeks, followed by a 12-week induction phase in either Sub-Study 1 (open-label feeder induction) or Sub-Study 2 (pivotal induction). Non-responders may enter a 12-week extended induction phase in Sub-Study 3. After treatment, participants not enrolling in the maintenance study will have a 6-week follow-up period. Throughout the study, participants will have scheduled visits for assessments, including monitoring of clinical remission and endoscopic response using standardized scoring systems at 12 weeks. The total number of visits varies depending on sub-study participation, with up to 15 visits for those in Sub-Study 3. Safety and treatment effects will be closely monitored during these visits and follow-up periods.

Researchers are evaluating the safety and effectiveness of duvakitug in people with moderately to severely active Ulcerative Colitis (UC). This multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study aims to see if duvakitug can help achieve clinical remission in this condition. The study targets participants aged 16 to 80 years with a confirmed diagnosis of active UC for at least 3 months who have not responded well or are intolerant to other treatments. Participants will receive either duvakitug or a placebo as a solution injected under the skin (subcutaneous injection). The study includes up to 35 weeks with multiple periods: a screening period, a 12-week induction phase (either open-label or randomized), a 12-week extended induction for those who do not respond initially, and a 45-day follow-up for those not continuing into the maintenance study. During these phases, participants may have up to 8 to 15 on-site visits depending on their sub-study group. Throughout the study, participants will be monitored closely with scheduled visits for assessments including clinical evaluations related to UC activity and response to treatment. The main outcome measured is the proportion of participants who achieve clinical remission by week 12. Safety and tolerability will also be tracked during and after the treatment period, with follow-up visits to ensure participant well-being.

The purpose of this prospective, non-randomized, single arm, event-based, multicenter trial is to assess: (1) the diagnostic accuracy of the device, (2) the compliance of the prescribing physician, (3) the experience of the implanting physician, (4) the experience of the emergency department physician and (5) the patient compliance for "Emergency" and "See Doctor" alerts. The adequacy of the training program for the prescribing physician, implanting physician, emergency department physician, and patients will be assessed. A minimum of 500 patients who have had prior ACS events and who remain at high risk for recurrent ACS events will be enrolled in the PAS, for the purpose of accruing 314 adjudicated True Positive (TP) or False Positive (FP) ACS events. These ACS events will contribute to the Positive Predictive Value (PPV) and false positive rate (FPR) endpoints of the study. The PAS will be completed once the 314 ACS events have been collected and adjudicated.

Researchers are evaluating the effects of dalcetrapib, a cholesterol ester transfer protein inhibitor, on cardiovascular risk in people who have recently been hospitalized for acute coronary syndrome (ACS) and have a specific genetic profile (AA genotype). This phase 3, placebo-controlled, randomized, double-blind study focuses on adults aged 45 years and older. Participants must be clinically stable and managed according to guidelines for low-density lipoprotein cholesterol (LDL-C). The study aims to measure the time to the first occurrence of any fatal or non-fatal myocardial infarction over an average follow-up of 30 months. Participants will be randomly assigned to receive either dalcetrapib 300 mg tablets or matching placebo tablets. The study includes a genetic screening phase to confirm the presence of the AA genotype using a specific genotype assay test. Screening and enrollment may start during hospitalization or after discharge, with randomization required within 12 weeks of the ACS event. Follow-up visits will be conducted virtually when possible every 3 months or as clinic visits until the study ends. If a participant stops the study medication early, assessments for study endpoints will continue every 3 months. Throughout the study, participants will undergo medical history reviews, genetic testing, and regular assessments to monitor cardiovascular events. Researchers will collect data on myocardial infarction occurrences as the primary outcome. Safety and adherence will be monitored through scheduled visits, and the study will continue until about 200 participants have experienced a primary event or until a planned interim analysis determines stopping. The total participation duration varies based on event occurrence but involves ongoing follow-up every 3 months after randomization.

Researchers are evaluating the effects of maridebart cafraglutide, given alongside standard care, in reducing heart failure events such as hospitalizations, urgent visits, cardiovascular deaths, and improving symptoms in people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This is a global phase 3, multicenter trial with a two-part design including a double-blind period followed by an open-label extension. The first part will end once around 850 key events have been recorded. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study includes an initial randomized, double-blind phase and a later open-label extension where all participants may receive the active treatment. The trial is designed to monitor participants over time to assess the safety and effects of the treatment compared to placebo. During the trial, participants will undergo assessments including monitoring for cardiovascular events, heart failure symptoms, and laboratory tests such as NT-proBNP levels. Researchers will track time until the first occurrence of cardiovascular death or heart failure events over approximately 35 months. Safety evaluations, adherence to treatment, and ongoing health status will be followed throughout the study period.