Chhatrapati Sambhajinagar

Researchers are conducting a Phase 1, open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose of AUR107 in adult patients with relapsed advanced solid tumors. These tumors include non-small cell lung cancer, gastric cancer, urothelial cancer, kidney cancer, colon cancer, and esophageal cancer. Participants must have no available curative or life-prolonging treatments and have exhausted all effective local therapies. Participants will receive oral AUR107 once daily. The study uses a traditional 3+3 dose escalation design to assess safety and determine the optimal biological dose based on safety, pharmacokinetics, and pharmacodynamics data. The treatment period focuses on finding the best dose and assessing how the drug behaves in the body. During the study, participants will be monitored for dose limiting toxicities and treatment-related adverse events over 28 days. Researchers will evaluate pharmacokinetics parameters such as maximum concentration, time to maximum concentration, area under the curve, mean residence time, and half-life at specified days. Safety assessments, disease measurements, and tolerability will be closely followed to understand the effects of AUR107.

Researchers are evaluating the effectiveness and safety of brenipatide when given along with standard care compared to a placebo with standard care in adults with bipolar disorder. This Phase 2 study aims to see if brenipatide can delay the worsening of bipolar symptoms. The trial includes participants aged 18 to 75 years and involves a careful assessment of how well the treatment works and its safety profile. The trial has three main periods: a screening period lasting about one month, a treatment period of at least six months, and a follow-up period of around two months. Participants receive either brenipatide or placebo, both given by subcutaneous injection, alongside their usual bipolar disorder medications. The study may end earlier if symptoms worsen or if participants withdraw for any reason. Participants will be asked to self-inject the study medication, maintain diaries, complete questionnaires, and attend regular visits throughout the study. Researchers will monitor the time to relapse, defined as the number of days from randomization until symptoms worsen according to specific criteria, over at least six months. Safety and adherence to treatment will also be closely observed during the study.

Researchers are evaluating the safety and effectiveness of brenipatide combined with standard care compared to a placebo with standard care in adults with schizophrenia. This phase 2 study aims to understand how well brenipatide works as an additional treatment for schizophrenia and monitor any side effects. Participants eligible for the study must have schizophrenia and be on stable standard care medication. The trial consists of three main periods: a screening period lasting about one month, a treatment period that can last up to 12 months, and a follow-up period of approximately two months. During the treatment phase, participants receive either brenipatide or placebo administered by subcutaneous injection alongside their standard care. The study includes careful monitoring and adherence to study procedures such as self-injection, keeping diaries, and completing questionnaires. Participants will be involved in regular visits and assessments throughout the entire study duration, which may last up to 15 months. Researchers will measure changes in body weight from baseline to week 52 as a primary outcome. Participants will also be monitored for safety and efficacy through ongoing evaluations, including the use of electronic or paper diaries and required questionnaires to track their progress and response to treatment.

Researchers are evaluating the safety and effectiveness of brenipatide at different doses compared with a placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study focuses on participants who have a history of asthma requiring controller medication and recent severe asthma exacerbations. The goal is to better understand how brenipatide impacts asthma control over an extended period. Participants will receive either brenipatide or a placebo, both administered by subcutaneous injection. The study includes a 52-week treatment period during which the effects of the drug on asthma exacerbations and symptoms will be monitored. This randomized, double-blind approach helps compare the responses between the treatment and placebo groups. Study involvement lasts about 65 weeks, covering screening, treatment, and follow-up phases. During the study, researchers will assess participants' asthma control using questionnaires and track the annual rate of asthma exacerbations. Safety and treatment responses will be closely monitored throughout the trial to evaluate the drug's impact and participant well-being.

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Researchers are evaluating the long-term safety and tolerability of adjunctive KarXT, a combination of xanomeline and trospium chloride, in adults aged 18 to 65 with schizophrenia who did not have sufficient symptom control with their current antipsychotic medications. This Phase 3, open-label extension study involves participants who previously completed the treatment period of the ARISE study (KAR-012). The goal is to monitor how well patients tolerate KarXT over an extended period while assessing related safety concerns. Participants receive fixed doses of KarXT capsules twice daily, with doses ranging from 50 mg/20 mg up to 125 mg/30 mg. The study lasts for 52 weeks as an outpatient program. This open-label extension allows researchers to observe the effects and safety of KarXT when added to stable antipsychotic treatment under real-world conditions. During the study, researchers closely monitor participants for any treatment-emergent adverse events from the initial dose through a safety follow-up visit at 54 weeks or early termination. Participants will undergo regular assessments, including clinical evaluations and reports from reliable caregivers who assist with study activities. The study ensures participants maintain stable living situations and continue their background antipsychotic medications throughout the study period.

Neonatal encephalopathy causes significant death and lifelong disabilities in babies born in low and middle-income countries (LMICs). Traditional cooling therapy used in high-income countries is not easily applicable or safe in LMICs. Erythropoietin (Epo), a drug commonly used to treat anemia, shows promise as a neuroprotective treatment for neonatal encephalopathy when used alone. Early studies suggest Epo may reduce death or disability without serious side effects, but a large, definitive trial is needed to confirm its safety and effectiveness in LMICs. This trial is a phase III, multi-country, double-blind study comparing Erythropoietin injections to placebo in babies with moderate or severe neonatal encephalopathy. Babies will receive nine doses of Epo at 500 units per kilogram, starting within six hours of birth and continuing daily for eight days. Alongside the drug treatment, all babies will receive supportive neonatal intensive care, including temperature monitoring to maintain normal body temperature and clinical support as needed. Participants will be closely monitored throughout the study, with brain imaging performed between one to two weeks of age to assess neurological effects. The primary outcome measured is the number of babies who die or survive with moderate or severe disability at 18 to 22 months. The trial includes an 18-month recruitment period, 18-month follow-up, and five months for data analysis, with a pilot phase conducted before the main trial begins.

Researchers are evaluating the effects of lumateperone compared to a placebo in children and teens aged 10 to 17 who are experiencing major depressive episodes linked to bipolar I or bipolar II disorder. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to understand how well lumateperone works and how safe it is in this young population. Diagnoses are confirmed using a structured clinical interview based on DSM-5 criteria. The study includes three phases: a screening period of up to 2 weeks to check if patients qualify, a 6-week double-blind treatment phase where participants are randomly assigned to take either lumateperone or a matching placebo once daily by mouth, and a 1-week safety follow-up after the last dose for health monitoring. Lumateperone is given orally once a day, and the placebo group receives a matching oral pill on the same schedule. Participants will attend clinic visits for assessments including the Children's Depression Rating Scale-Revised (CDRS-R) measured at week 6 to evaluate depressive symptoms. Safety follow-up occurs about one week after treatment ends. Throughout the study, researchers monitor symptoms, side effects, and overall health to assess the treatment's impact and safety over the 7 to 9 week total participation time including screening and follow-up.