Cocoa

Researchers are evaluating the efficacy and safety of ZL-1310 compared to Investigators Choice Therapy in adults with relapsed Small Cell Lung Cancer SCLC. This phase 3, randomized, open-label study aims to compare treatment responses and overall survival between these two therapies in participants who have previously received platinum-based systemic therapy or tarlatamab. Participants are randomly assigned to receive either ZL-1310 as a single-agent drug or Investigators Choice Therapy, which includes Topotecan, Lurbinectedin, or Amrubicin. The study follows a parallel design and monitors participants during treatment and follow-up periods lasting up to 27 months to assess various outcomes. During the study, participants undergo regular evaluations including tumor assessments based on RECIST v1.1 criteria, brain metastases response evaluations, and quality of life measurements using validated questionnaires. Safety is closely monitored by tracking treatment-emergent adverse events. Participants are expected to comply with study procedures, including tumor biopsies or providing archived tissue samples, and the total study duration may extend to nearly three years.

Researchers are evaluating telisotuzumab adizutecan, alone or combined with osimertinib, compared to standard care in adults with locally advanced or metastatic EGFR-mutated non-squamous non-small cell lung cancer NSCLC. The study aims to assess adverse events and changes in disease activity, enrolling approximately 490 adults worldwide. It includes two phases phase 2 to test doses and combinations, and phase 3 to compare the recommended dose to standard care. During phase 2, participants receive one of two intravenous doses of telisotuzumab adizutecan, either alone or with oral osimertinib. In phase 3, participants receive the recommended phase 3 dose of telisotuzumab adizutecan or standard of care. The entire study lasts about 69 months, with participants undergoing assigned treatments according to their groups. Participants will attend regular visits at approved hospitals or clinics for medical assessments, blood tests, questionnaires, and monitoring of side effects. Researchers will measure objective response and progression-free survival through blinded independent central review over the study duration. Quality of life and lung cancer symptoms will also be evaluated. Safety and overall survival will be tracked throughout the trial.

Researchers are evaluating the pharmacokinetic comparability between TAK-881 and HYQVIA when given as subcutaneous injections for maintenance therapy in adults with chronic inflammatory demyelinating polyradiculoneuropathy CIDP. This phase 3 trial focuses on participants who have been receiving intravenous or subcutaneous immunoglobulin treatments and aims to compare these two treatments in terms of how the body absorbs and processes them. The study includes several phases starting with screening and possibly a ramp-up phase for those switching treatments. Participants already on HYQVIA go directly to that treatment phase, which lasts 18 to 20 weeks depending on dosing intervals. Then all participants switch to TAK-881 for 24 weeks. After this, an extension phase allows continued treatment for up to 3 years, with home infusions permitted and clinic visits spaced between 12 and 24 weeks. Treatments are given by subcutaneous infusion using specialized needle sets. Participants will visit the clinic every 3 or 4 weeks during the initial phases to undergo assessments including blood sampling to measure immunoglobulin G levels at various time points. The study also tracks clinical disability scores, hand grip strength, muscle strength, and adverse events over time. Safety and treatment tolerability are closely monitored throughout the trial. Total participation may last several years including the extension phase.

Researchers are evaluating the effectiveness of a single dose of Staccato alprazolam compared with a placebo to quickly stop prolonged seizure episodes in people aged 12 years and older with stereotypical prolonged seizures. The study aims to determine if the treatment can stop seizures within 90 seconds and prevent recurrence for up to 2 hours after administration. This is a phase 3, randomized, double-blind clinical trial sponsored by UCB Biopharma SRL. Participants are randomly assigned to receive one dose of either Staccato alprazolam or placebo by inhalation during the treatment period. The study involves a parallel-group design with one treatment administration. Participants are observed for the treatments effect on seizure cessation and recurrence for up to 6 hours. During the study, participants and their caregivers will be monitored for seizure activity and safety outcomes. Various assessments include measuring treatment success within 90 seconds and seizure recurrence at 2, 4, and 6 hours after treatment. Safety is tracked through adverse event monitoring, with follow-up extending to 19 weeks after treatment. The total participation duration is based on these assessments and monitoring periods.

This research aims to evaluate the safety and effectiveness of the FastWire System in patients with chronic total occlusions CTOs in the peripheral arteries causing ischemic limbs. It is a single-arm, multi-center, pivotal study involving up to 65 participants who meet specific inclusion and exclusion criteria. The study focuses on assessing whether the FastWire System can assist in placing guidewires or treatment devices beyond these arterial blockages. Participants will undergo a procedure using the FastWire System device to cross CTO caps and multiple lesions in their peripheral arteries. The study does not involve comparison groups and monitors clinical and technical success on the day of the procedure, along with safety events up to 30 days afterward. The device is used intra-luminally during the procedure to facilitate revascularization of lower limbs. During the study, participants will be closely monitored for clinical success and freedom from serious adverse events on the procedure day and up to 30 days post-procedure. Researchers will evaluate technical and procedural success, vessel dissection or bleeding within 24 to 36 hours, and any procedure-related mortality up to 30 days. The total study involvement lasts through the initial procedure and a 30-day follow-up period to assess safety and efficacy outcomes.

Researchers are evaluating the efficacy and safety of Imeroprubart in adults with active Chronic Inflammatory Demyelinating Polyneuropathy CIDP, a condition affecting the peripheral nerves. This Phase 2b, multi-center, randomized, double-blind, placebo-controlled study aims to understand how well Imeroprubart works compared to placebo in treating CIDP. The study is sponsored by Immunovant Sciences GmbH and focuses specifically on adults meeting diagnostic criteria for typical or variant forms of CIDP. Participants will receive either Imeroprubart or a matching placebo by subcutaneous injection once weekly. The treatment period includes an initial 24-week phase Period 1 with Imeroprubart or placebo, followed by an extension to 52 weeks Period 2 for continued evaluation. Imeroprubart dosing is given once weekly via subcutaneous injection. Placebo is provided similarly during the first 24 weeks. During the study, participants will be monitored through clinical assessments including relapse status by Week 24, as well as measurements of disability, grip strength, muscle strength, and symptom scores. Electrodiagnostic tests support diagnosis at baseline. Safety and efficacy will be closely observed during treatment, with follow-up visits scheduled to assess outcomes. The total participation duration covers at least 24 weeks for the primary outcome assessment, with ongoing monitoring as defined by the study protocol.

Researchers are conducting the FLEX Registry, a large-scale, population-based study focusing on patients with stage I to III breast cancer who have undergone MammaPrint and BluePrint testing on their primary breast tumors. This observational registry aims to gather comprehensive full genome expression data linked with clinical information to explore new gene associations that may have prognostic or predictive value. The design is adaptive, allowing additional targeted substudies and arms to be added over time for more specific investigations. All participants will have their tumor samples tested using MammaPrint and BluePrint through the full-genome testing array provided by Agendia. Treatment decisions are made by the treating physician following NCCN guidelines or recognized alternatives, with no specific treatment mandated by the study. The registry plans to enroll about 30,000 patients from more than 125 US institutions, encompassing various treatment arms detailed in study appendices. Participants will have clinical data collected online at multiple time points at enrollment, during treatment, and at 1, 3, 5, and 10 years after diagnosis. This long-term follow-up allows researchers to study gene expression alongside clinical outcomes, supporting the creation of subgroup analyses and future targeted trials. The primary outcomes include establishing a large-scale full genome expression registry and providing infrastructure for examining smaller patient groups over the 10-year study period.

Researchers are evaluating the Velocity Percutaneous Arteriovenous Fistula pAVF System, a new minimally invasive device designed to create dialysis access for adults with kidney failure. This study aims to assess the safety and effectiveness of this catheter-based approach compared to traditional surgical methods. The study includes adults aged 18 to 80 years who require hemodialysis access or are expected to need it within six months. Participants will undergo the Velocity pAVF procedure, which creates an arteriovenous fistula through a small skin puncture without open surgery. After the procedure, they will be monitored with physical exams, duplex ultrasounds, and dialysis assessments to evaluate fistula maturation, usability, and long-term function. Any additional procedures needed to assist maturation or maintain access will be recorded. Safety monitoring will include tracking device- and procedure-related complications. During the study, participants will have follow-up visits for up to five years, during which their fistulas functional and physiological maturation will be assessed at specific intervals, including 6 weeks, 3 months, 6 months, and yearly thereafter. Researchers will measure outcomes such as time to first hemodialysis, catheter use duration, patency rates, and adverse events. This long-term follow-up will help gather information to improve dialysis access care.

Researchers are evaluating the safety and effectiveness of a new oral drug called daraxonrasib compared to the chemotherapy drug docetaxel in patients with non-small cell lung cancer NSCLC that has a specific RAS mutation. This Phase 3, randomized, open-label study aims to see if daraxonrasib can improve progression-free survival or overall survival in patients who have already received prior treatments. The study focuses on patients with locally advanced or metastatic NSCLC who cannot be cured with surgery or radiation. Participants will be randomly assigned in equal groups to receive either daraxonrasib tablets or docetaxel by intravenous infusion. The treatments will be given according to the study plan, and participants will be monitored over about four years. The study includes careful assessment of response to treatment, safety, quality of life, and drug characteristics during this period. During the trial, participants will undergo regular evaluations including imaging scans to measure tumor size, assessments of side effects, blood tests to check organ function, and questionnaires about quality of life. Researchers will track how long patients live without disease progression and overall survival, along with treatment effects and tolerability. This follow-up and monitoring will continue for up to approximately four years, ensuring comprehensive data collection throughout the study duration.

Researchers are studying the effects of IMVT-1402 in adults with mild to severe generalized myasthenia gravis, a condition affecting muscle strength. This Phase 3 trial aims to evaluate the efficacy, safety, and tolerability of IMVT-1402 as a treatment option compared to a placebo. The study is randomized and triple-blinded to ensure reliable results. Participants will receive one of two doses of IMVT-1402 or a placebo, all administered by subcutaneous injection once weekly. The treatment periods include an initial 12-week phase, followed by extended dosing periods of 14 weeks and 52 weeks for some groups. The study is designed to assess responses across these timeframes. During the trial, participants will be monitored through various assessments including the MG activities of daily living MG-ADL score and the Quantitative Myasthenia Gravis QMG score. The main outcome focuses on changes in MG-ADL from baseline to week 12. Safety and tolerability will also be tracked throughout the treatment and follow-up periods. The overall participation may last up to several months depending on the treatment group.