Cocoa

This trial studies participants with relapsed Small Cell Lung Cancer who have received prior treatment. It aims to compare the effectiveness and safety of a new drug called ZL-1310 with therapies chosen by investigators, such as Topotecan, Lurbinectedin, or Amrubicin. This is a Phase 3, randomized, open-label study evaluating outcomes including tumor response rate and overall survival over a period of up to 27 months. Participants receive either ZL-1310 alone or one of the Investigator's Choice therapies as treatment. The study includes screening to confirm measurable disease and eligibility. Treatments are administered according to the study protocol, and tumor biopsies or archived tissue samples are collected at screening. Both treatment groups are monitored for response and side effects throughout the study period. During the trial, participants undergo regular assessments including tumor imaging evaluated by an independent review, and survival status is tracked for up to 27 months. Researchers monitor safety, treatment adherence, and disease progression. Participants are expected to comply with study visits and procedures for the entire duration of the trial to help evaluate the benefits and risks of the treatments.

Non-small cell lung cancer (NSCLC) is a common form of lung cancer characterized by uncontrolled growth of abnormal lung cells. This research aims to compare the safety and changes in disease activity of the investigational drug telisotuzumab adizutecan against the current standard of care in adults with locally advanced or metastatic EGFR-mutated non-squamous NSCLC. The study includes two stages: phase 2 and phase 3, involving approximately 430 participants worldwide. During phase 2, participants receive one of two doses of telisotuzumab adizutecan through intravenous infusion. In phase 3, participants are given the recommended phase 3 dose identified in phase 2 or standard of care treatments. The study treatments are administered intravenously, and the entire study duration is about 69 months. Participants will attend regular visits at approved hospitals or clinics for medical assessments, blood tests, questionnaires, and monitoring of side effects. Researchers will evaluate objective response and progression-free survival to assess treatment effects. Careful safety monitoring and frequent evaluations will be conducted throughout the study period.

Researchers are evaluating the pharmacokinetic (PK) comparability between TAK-881 and HYQVIA, both given as subcutaneous (SC) infusions, for maintenance treatment of adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). This Phase 3 trial includes participants who have previously received intravenous or subcutaneous immunoglobulin G treatments and aims to compare these two therapies' behavior in the body. Participants must have a confirmed diagnosis of CIDP and have responded to IgG treatment before, consistent with established diagnostic criteria. The study consists of multiple phases: screening, a ramp-up phase if needed, a HYQVIA treatment phase, a TAK-881 treatment phase, and finally, an extension phase. Participants who previously received conventional subcutaneous or intravenous immunoglobulin will start with a HYQVIA ramp-up phase 1 to 2 weeks after their last dose. Those already on HYQVIA proceed straight to treatment. Participants receive SC infusions of HYQVIA for 20 weeks, then switch to TAK-881 for 24 weeks. During the extension phase, home infusions are preferred, with clinic visits spaced between 12 and 24 weeks. Throughout the study, participants visit the clinic every 3 or 4 weeks during the initial phases. Researchers will monitor immunoglobulin G levels through blood tests at specified intervals to assess drug exposure. Safety and treatment adherence are tracked, and participants complete disability assessments. The total duration includes these treatment phases and the extension, with careful follow-up to evaluate the therapies' pharmacokinetic profiles and participant well-being.

Researchers are evaluating the effectiveness and safety of a single inhaled dose of Staccato alprazolam compared to a placebo in quickly stopping prolonged seizure episodes in people aged 12 years and older with stereotypical prolonged seizures. This Phase 3 study aims to determine if the treatment can stop seizures within 90 seconds and prevent seizure recurrence for up to 2 hours after administration. Participants will receive one inhaled dose of either Staccato alprazolam or a placebo during the treatment period. The study is randomized, double-blind, and placebo-controlled, conducted at multiple outpatient centers. The intervention consists of a single administration designed to rapidly terminate seizure episodes. During the study, participants are closely monitored for seizure treatment success within 90 seconds and no seizure recurrence up to 2 hours post-treatment. Researchers will assess seizure control and safety outcomes throughout the treatment period. The study involves baseline assessments, caregiver involvement to observe seizures, and a focus on quick treatment response and safety over several hours following drug administration.

Researchers are conducting a Phase 3 study to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of ABP 692 with Ocrelizumab (both US and EU versions) in people with relapsing-remitting multiple sclerosis (RRMS). The study aims to show similarity between these treatments by measuring how the drugs behave in the body and their effects on suppressing new active brain lesions over 24 weeks using MRI scans. Participants will receive intravenous infusions of either ABP 692, Ocrelizumab (US), or Ocrelizumab (EU). The study design allows comparison between these three groups to assess how the drugs are processed and how well they control disease activity. Infusions are given according to the study schedules, and the effects are monitored over the following weeks. During the study, participants will have regular assessments including brain MRI scans to count new lesions, blood tests to measure drug levels, and neurological evaluations to track disease status. The main outcomes include drug concentration over time and the number of new brain lesions up to week 24. Safety and clinical effects will also be observed throughout the study period, which includes screening and follow-up visits.

Researchers are evaluating the safety and effectiveness of the FastWire System in patients who have chronic total occlusion (CTO) in the arteries of their lower limbs, which causes poor blood flow and ischemic limbs. This pivotal, single-arm, multi-center study plans to enroll up to 65 participants with severe claudication or critical limb-threatening ischemia (CLTI) to assess whether the FastWire System can successfully assist in placing guidewires or treatment devices through blocked peripheral arteries. During the procedure, investigators will use the FastWire System to cross the CTO caps or multiple lesions in the affected arteries below the origin of the superficial femoral artery, either above or below the knee. Participants must have angiographic confirmation of a de novo CTO with a total length less than 40 cm and at least one patent runoff vessel if the CTO is below the knee. The study does not include a comparison group and focuses on the performance of this device in real-world clinical settings. Participants will be closely monitored for clinical success on the day of the procedure and for freedom from serious adverse events up to 30 days afterward. The study involves detailed imaging assessments at the time of the procedure and ongoing safety evaluations. Overall participation will cover the procedure day and follow-up through the first month to assess initial safety and efficacy outcomes related to the FastWire System.

Researchers are evaluating the safety and effectiveness of a drug called Imeroprubart in adults who have Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition affecting the nerves. This Phase 2b study is conducted at multiple centers and uses a randomized, double-blind, placebo-controlled design to compare Imeroprubart with a placebo in participants with active CIDP. Participants receive either Imeroprubart or a matching placebo by subcutaneous injection once a week. The treatment is given for 24 weeks during the first period, followed by an extension period of 52 weeks for continued monitoring. Imeroprubart is dosed once weekly by injection under the skin, and the placebo group receives matching injections during the initial 24 weeks. Throughout the study, participants undergo various assessments to monitor their health and response to treatment. Researchers measure the proportion of participants who remain free from disease relapse by Week 24. Safety and efficacy are closely tracked with clinical evaluations and diagnostic tests. The total duration of participation includes the treatment periods and follow-up to observe outcomes and potential side effects.

Researchers are conducting the FLEX Registry to study patients with stage I to III breast cancer who receive MammaPrint and BluePrint testing on a primary breast tumor. This large-scale, population-based, prospective registry aims to create a comprehensive database of full genome expression linked with clinical data to explore new gene associations that may have prognostic or predictive value. The registry uses an adaptive design, allowing additional targeted substudies and arms to be added over time. The study involves patients from over 125 U.S. institutions, with an anticipated enrollment of around 30,000 participants. Treatment decisions are made by physicians following NCCN-approved regimens or recognized alternatives. MammaPrint and BluePrint tests are performed by Agendia using the full genome testing array. Data collection occurs at enrollment, during treatment, and at follow-up intervals of 1, 3, 5, and 10 years after diagnosis. Participants will have clinical data entered online at specified time points, with the goal of generating hypotheses for targeted subset analyses and further trials based on the genetic data collected. Outcome measures include the creation of a large registry for gene expression and clinical data over 10 years and the development of shared registry infrastructure to study smaller patient groups. This is an observational phase IV study focused on long-term data gathering and analysis.

Researchers are evaluating the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new minimally invasive device designed to create dialysis access in adults with kidney failure. This system aims to offer an alternative to traditional surgical methods that require incisions and longer recovery times. The study focuses on how safe and effective this catheter-based approach is for patients needing hemodialysis access. All participants will receive the Velocity pAVF device, which creates an arteriovenous fistula through a small puncture in the skin without open surgery. The procedure is intended to simplify fistula creation and improve maturation consistency and long-term function. This multicenter pivotal study will follow patients undergoing the Velocity procedure to gather detailed safety and performance data. Participants will be closely monitored after the procedure with exams, ultrasounds, and dialysis assessments for up to five years. Researchers will measure physiological maturation of the fistula at 6 weeks and track any serious adverse device effects within 30 days. The study includes regular follow-up visits and assessments to evaluate the device's performance and patient outcomes over time.

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 global study focuses on patients whose cancer has locally advanced or spread and who have already received prior treatments. The goal is to see if daraxonrasib can improve the time patients live without their cancer worsening and overall survival. Participants will be randomly assigned to receive either daraxonrasib tablets taken by mouth or docetaxel given by intravenous infusion. The study is open-label, meaning both doctors and patients know which treatment is given. Treatment continues as long as it is appropriate, and patients are monitored throughout the study period. During the trial, patients will undergo regular assessments to measure disease progression and survival up to about four years. Researchers will evaluate progression-free survival and overall survival as the main outcomes. Patients must have measurable disease and meet health criteria, and their RAS mutation status will be confirmed. Safety and effectiveness will be closely monitored throughout the study.