Alzira

Researchers are evaluating the use of personalized, dynamic titanium prostheses made with 3D printing to reconstruct the chest wall after tumor removal or severe trauma. This study addresses the challenges of traditional rigid reconstruction methods that can cause pain or breathing difficulties by testing implants designed to mimic natural rib movement, potentially improving function and comfort. The study is a multicenter, ambispective registry collecting both retrospective and prospective data across major Spanish hospitals. The treatment involves creating a custom 3D-printed titanium prosthesis based on preoperative CT scans, manufactured using titanium alloy powder. During surgery, the prosthesis is implanted and anchored to the ribs or sternum to restore chest wall integrity while preserving natural dynamics. The study includes retrospective cases and prospective enrollment over 24 months, with follow-up evaluations at discharge, 1 month, 6 months, and 12 months post-surgery. Participants will undergo assessments including pulmonary function tests, pain scales, imaging like X-rays and CT scans, and quality of life questionnaires. Data is securely stored and anonymized in a centralized database compliant with European data protection laws. The primary outcomes measure changes in lung function parameters over one year. Participants can withdraw at any time, and the study aims to improve prosthesis design and surgical practices through comprehensive monitoring and analysis.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the efficacy and safety of eloralintide compared with placebo for reducing body weight in adults with overweight or obesity who also have type 2 diabetes. This phase 3 study is designed to assess the treatments effects over a course of about 75 weeks, aiming to provide insights into managing weight in this population. Participants are randomly assigned to receive one of several doses of eloralintide or a placebo, all administered by weekly subcutaneous injections. The study involves a double-blind design, meaning neither participants nor researchers know which treatment is given. The treatment period lasts 64 weeks, during which body weight and other health measures are closely monitored. Participants will undergo regular assessments including measurements of body weight, fat mass, waist circumference, blood sugar control HbA1c, blood pressure, and other health indicators. Questionnaires about quality of life and eating behavior are also used. Safety and medication use changes are tracked throughout. Participation includes screening, treatment, and follow-up visits over the total duration of about 75 weeks.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating the safety and tolerability of TAK-861 in people with narcolepsy type 1 NT1. This study focuses on participants who have already been exposed to TAK-861 doses in previous clinical trials. The goal is to monitor how TAK-861 affects symptoms such as excessive daytime sleepiness and cataplexy episodes over a long period. All participants in this trial will receive TAK-861 tablets. Those who previously received a placebo will be randomly assigned to one of the TAK-861 dose groups. The study is a long-term extension conducted worldwide and is expected to last approximately five years or until the product is approved or the study is stopped. Participants may switch doses as needed and will attend multiple clinic visits, some of which can be done at home. Throughout the trial, participants will be regularly assessed for safety by tracking any treatment-emergent adverse events. Researchers will also measure changes in sleep latency, sleepiness scores, and cataplexy rates compared to baseline data from earlier trials. Follow-up assessments will take place four weeks after the final dose to monitor ongoing effects and ensure participant safety.

Researchers are studying the effect of Debio 4126, a 12-week extended-release octreotide injection, in maintaining insulin-like growth factor 1 IGF-1 levels at or below the upper limit of normal in patients with acromegaly who have previously been treated with somatostatin analogs. This Phase 3 randomized trial compares Debio 4126 to a placebo during a double-blind period to evaluate its efficacy and safety. Participants in the double-blind period receive intramuscular injections of either Debio 4126 or placebo every 12 weeks for 36 weeks, totaling three injections. Those whose IGF-1 levels remain at or below the upper limit of normal at Week 34 may enter an open-label phase receiving Debio 4126 injections every 12 weeks for an additional 24 to 60 weeks. Rescue medication is allowed for participants whose acromegaly is not well controlled during specified times. Throughout the study, participants undergo evaluations of IGF-1 levels, growth hormone levels, and treatment tolerability, including assessments of injection site reactions and adverse events. The primary outcome is the percentage of participants with IGF-1 levels at or below the upper limit of normal at 36 weeks. Safety and efficacy measures continue for up to 108 weeks, with ongoing monitoring of medication levels and rescue treatment use.

Researchers are evaluating the effectiveness of TAR-210 compared to investigators choice of intravesical chemotherapy in people with intermediate-risk non-muscle invasive bladder cancer IR-NMIBC who have specific FGFR mutations or fusions. This Phase 3 randomized study aims to compare disease-free survival between these treatment options, with the goal of understanding which may better prevent recurrence or progression of the cancer. Participants are randomly assigned to one of two groups. Group A receives TAR-210, which is inserted into the bladder on Day 1 and removed after 12 weeks, with one insertion every 12 weeks over about one year. Group B receives intravesical chemotherapy using mitomycin C or gemcitabine, chosen by the investigator, given once weekly for 4 to 6 doses followed by maintenance treatment for at least six months up to one year. The study includes a substudy with similar treatment groups. During the trial, participants will undergo multiple cystoscopies and urinary tumor resections as needed to monitor for disease recurrence or progression. Researchers will measure disease-free survival from the time of randomization until recurrence, progression, or death over approximately four years. Additional assessments include quality of life questionnaires, adverse events monitoring, and survival outcomes. Participants are followed closely with various evaluations throughout the study duration.

Researchers are evaluating the optimal doses of the drug E2086 compared to placebo in adults with narcolepsy, a condition characterized by excessive daytime sleepiness EDS. The study focuses on reducing EDS as measured by the Mean Sleep Latency MSL using the first four maintenance of wakefulness tests MWTs. This Phase 2 trial includes participants diagnosed with either narcolepsy type 1 NT1 or type 2 NT2 within the last 10 years. Participants will be randomly assigned to receive either E2086 or a matching placebo tablet taken orally once daily for four weeks at low, middle, and high doses. Each dosing period is separated by a washout period of at least seven days, with a total treatment duration of approximately 14 weeks. This design allows comparison of the effects of different doses of E2086 on narcolepsy symptoms. During the study, participants will undergo assessments to measure changes in sleep latency, cataplexy episodes, and sleepiness scales. Additional safety evaluations include monitoring for adverse events, laboratory tests, vital signs, ECG parameters, and suicidality assessments. Blood samples will be collected to analyze drug concentration levels. The study involves regular monitoring up to Day 113 and aims to assess both efficacy and safety over the course of treatment and follow-up.

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 studying TAK-861 to evaluate its effectiveness and safety for treating narcolepsy type 1 with cataplexy. This phase 3 trial aims to determine whether TAK-861 helps control symptoms and if its benefits last over time, as well as to monitor any side effects related to taking or stopping the drug. Participants will first take TAK-861 openly for several months during the open-label treatment period. Those who meet certain criteria will then be randomly assigned to continue TAK-861 at the same dose or switch to placebo for up to 4 weeks in a double-blind randomized withdrawal period. If symptoms worsen during this period, participants may stop treatment and join a long-term extension study or be followed for 4 weeks after their last dose. During the study, participants will undergo assessments including the Epworth Sleepiness Scale, Maintenance of Wakefulness Test, cataplexy rate tracking, cognitive tests, and patient-reported outcomes. Safety will be monitored throughout the trial, which lasts approximately 31 weeks from screening to study end. The study is conducted at multiple centers worldwide.