Ajmer

Researchers are evaluating the safety, immune response, and consistency between different vaccine lots of BBV87, an inactivated Chikungunya virus vaccine, in healthy individuals aged 12 to 65 years. This Phase IIIII clinical trial is randomized, observer-blind, and placebo-controlled, aiming to understand how well the vaccine works and its safety profile across multiple study centers. Participants will be randomly assigned to receive one of three lots of the BBV87 vaccine or a placebo. Each subject will receive two doses of 40 micrograms administered as injections into the deltoid muscle of the arm, with the second dose given about 28 days after the first. Safety data will be reviewed by an independent board during the study to ensure participant protection. During the study, participants will attend visits for vaccination and follow-up assessments, including blood tests to measure antibody levels against the virus 28 days after each dose. Researchers will monitor for any adverse events for up to 11 months post-vaccination. The main outcomes measured include immune response levels and the percentage of participants who develop antibodies, along with the safety and tolerability of the vaccine.

Researchers are evaluating the safety and effectiveness of tirzepatide in adult participants in India who either have type 2 diabetes or are obese or overweight without type 2 diabetes. This phase 4, open-label study aims to understand how tirzepatide works in these groups over approximately 46 weeks. Participants will receive tirzepatide administered by subcutaneous injection. The study includes one treatment arm where all participants receive this medication. Research will focus on tracking serious adverse events related to the drug, as well as changes in body weight, blood sugar control HbA1c, and waist size over the study period. During the 46 weeks of participation, individuals will have regular visits for safety monitoring and assessments. Researchers will measure serious side effects, body weight reduction, HbA1c levels for those with diabetes, and waist circumference changes. This detailed monitoring helps evaluate the drugs impact and gather safety data throughout the treatment period.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 with mild to severe Alzheimers Disease who experience moderate to severe psychosis related to this condition. This Phase 3 trial aims to study KarXT compared to a placebo to better understand its impact on psychotic symptoms associated with Alzheimers. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses on certain days. The study lasts up to 14 weeks, during which changes in psychosis symptoms, as measured by the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, will be closely monitored. Additional assessments include cognitive tests and monitoring for side effects. During the trial, participants will undergo regular evaluations including symptom ratings, cognitive tests such as the Mini-Mental State Examination, laboratory tests, and safety monitoring. Researchers will track any adverse events and changes in mental and physical health. The study aims to provide detailed information about how KarXT affects psychosis and cognition in Alzheimers disease over the treatment period.

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 the effects and safety of the medicine PF-07275315 for adults aged 35 to 80 with moderate to severe chronic obstructive pulmonary disease COPD. COPD makes breathing difficult and reduces quality of life. This clinical trial aims to evaluate PF-07275315 compared to placebo to assess its potential as a treatment for COPD. Participants will receive either multiple injections of PF-07275315 or placebo shots in a clinic over 24 weeks for the Phase 2 part and 52 weeks for the Phase 3 part. The study uses a randomized and parallel design to compare outcomes between the groups. Phase 2 participants will have 11 clinic visits over about 40 weeks, while Phase 3 participants will have 18 visits over about 68 weeks. During the trial, participants will undergo lung function tests including forced expiratory volume FEV1 measurements, and assessments of COPD exacerbations. Researchers will monitor safety, adverse events, and changes in respiratory symptoms and quality of life. The study includes regular clinic visits for treatment and evaluations, with the total duration depending on the phase of participation.

Researchers are evaluating the use of rimegepant for intermittent prevention of menstrual migraine in women aged 18 to 45 who experience migraine attacks related to their menstrual cycle. This Phase 3, double-blind, randomized study compares rimegepant with placebo to assess its efficacy and safety during the peri-menstrual period. The study focuses on migraine frequency and severity in women with a history of menstrual migraine and regular menstrual cycles. Participants receive either rimegepant 75 mg orally disintegrating tablets for 7 days during each peri-menstrual period or a matching placebo, along with standard care for acute migraine treatment as needed. The study treatment cycles are repeated over 5 menstrual cycles in the double-blind treatment phase. The study also includes an acute treatment dosing option with rimegepant as needed. During the study, participants will be monitored for changes in the number of migraine and headache days, use of migraine medications, and functional disability related to migraine. Cognitive function is also assessed. Researchers will conduct evaluations over 5 months, covering 5 menstrual cycles, and measure outcomes related to migraine frequency and severity during the peri-menstrual period. Safety and tolerability will be closely monitored throughout the study.

This research focuses on people with psychosis linked to Alzheimers Disease who have completed earlier studies CN012-0026, CN012-0027, or CN012-0056. It is a Phase 3 global, multicenter, open-label extension study lasting 52 weeks that aims to evaluate the long-term safety and tolerability of KarXT in this population. Participants will receive KarXT capsules containing Xanomeline and Trospium Chloride. The study includes various dosing levels ranging from 202 mg to 66.76.67 mg taken three times daily. This open-label extension follows completion of previous studies and continues for up to 54 weeks from the initial dose, including a 14-day safety follow-up after the final dose. During the study, participants will be monitored for treatment-emergent adverse events and serious adverse events. Safety assessments include clinical evaluations throughout the treatment and 14 days after the last dose. The total participation time is approximately one year, allowing researchers to understand long-term effects of KarXT in this group.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

Researchers are observing the use of ImmunoglobulinHistamine Complex IHC, also known as Histoglob, in patients aged 13 years and older who have Chronic Urticaria in India. This real-world evidence study aims to assess how effective and safe Histoglob is for managing this condition, particularly in patients who are not controlled by first-line treatments like antihistamines. Participants in this observational study receive Histoglob injections, administered as a single 1 mL subcutaneous dose via prefilled syringe. The study focuses on patients who have been prescribed Histoglob for the first time as part of their routine care, without altering their usual treatment plans. There is no placebo or comparison group, as this is a non-interventional study following patients in real-world settings. During the approximately one-year study period, participants will be monitored for clinical improvement using the Urticaria Activity Score UAS7. Researchers will also track changes in antihistamine and other medication use, quality of life measures, and safety and tolerability throughout the study. Participants will continue their regular care while providing data through this observation to help evaluate Histoglobs role in managing Chronic Urticaria.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled study to evaluate lumateperone as an additional treatment for adults with Major Depressive Disorder MDD who have not responded well to ongoing antidepressant therapy. The study focuses on patients diagnosed with MDD according to DSM-5 criteria, including those with psychotic features, who have experienced an inadequate response to at least two antidepressant treatments during their current major depressive episode. Participants will be randomly assigned to receive either lumateperone 42 mg capsules or matching placebo capsules taken orally once daily for six weeks during the double-blind treatment period. The trial includes three periods a screening period of up to two weeks to assess eligibility, the six-week treatment period, and a one-week safety follow-up period after the last dose to monitor participant safety. During the study, participants will undergo assessments including depression severity ratings using the Montgomery-Asberg Depression Rating Scale and the Clinical Global Impression Scale. Researchers will monitor symptoms, treatment adherence, and safety throughout the treatment and follow-up periods. Total participation spans approximately nine weeks, covering screening, treatment, and safety monitoring.