Patna

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are evaluating the safety and immune response of BBV87, an inactivated Chikungunya virus vaccine, in healthy individuals aged 12 to 65 years. This seamless Phase II/III clinical trial aims to study the vaccine's immunogenicity, safety, and consistency across different production lots. The study involves approximately 1000 participants randomized regardless of their prior exposure to Chikungunya virus. Participants will be randomly assigned in a 3:3:3:1 ratio to receive one of three lots of the BBV87 vaccine or a placebo. Each participant will receive two doses of the vaccine or placebo, with each vaccine dose containing 40 micrograms of the inactivated virus. The study is observer-blind, and safety data will be reviewed by an independent board after Day 56 to ensure participant protection. During the study, participants will undergo assessments to measure antibody levels 28 days after the second vaccine dose. Researchers will monitor immune responses, including the percentage of participants who develop antibodies and the consistency of antibody levels across vaccine lots. Safety evaluations will be ongoing throughout the trial to assess any adverse effects or concerns related to the vaccine. The total participation period includes vaccination and follow-up visits up to Day 56.

This research aims to assess the safety and effectiveness of guselkumab treatment in Indian adults with psoriatic arthritis, a chronic autoimmune condition causing joint inflammation. The study focuses on participants who have not responded well to standard therapies, including conventional drugs and biologics. It is a Phase IV, open-label, multicenter study designed to evaluate this treatment in a real-world setting. Participants will receive guselkumab as a subcutaneous injection. The study includes careful screening for tuberculosis before starting treatment, requiring specific tests and chest X-rays to rule out active or latent TB. The treatment phase lasts up to 32 weeks, during which participants will be monitored for any adverse events or serious adverse events. During the study, participants will undergo physical exams, medical history reviews, vital signs checks, and ECGs to ensure medical stability. Women of childbearing potential will have pregnancy tests. Researchers will closely track safety by recording any adverse events over the 32-week period. The study aims to gather comprehensive data on how well guselkumab works and how safe it is for treating psoriatic arthritis in this population.

Researchers are evaluating the effectiveness, safety, and tolerability of mavorixafor in people aged 12 and older who have congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders. These participants experience repeated and/or serious infections due to low neutrophil levels. The study aims to show clinical benefit by increasing circulating neutrophils and reducing infection rates. Participants will continue their existing treatments, which may include granulocyte-colony stimulating factor (G-CSF), immunoglobulin replacement, prophylactic antibiotics, or observation without active treatment. They will be randomly assigned to receive either mavorixafor or a placebo, with both drugs given according to a set schedule. The study is double-blind and placebo-controlled, conducted across multiple centers. During the study, researchers will monitor participants for up to 52 weeks, focusing on the annual infection rate and the number of participants achieving a positive response in absolute neutrophil count. Participants will undergo regular assessments, including blood tests to measure neutrophil levels and evaluations for infections. The study includes safety monitoring and requires participants to maintain stable doses of their background therapies unless safety concerns arise.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the effectiveness and safety of T1695 compared to Ciclosporin in treating participants aged 4 to under 18 years with moderate to severe Vernal Keratoconjunctivitis (VKC). This phase 2 study focuses on individuals who have a high clinical severity of VKC based on the Bonini scale. The goal is to better understand how these two treatments perform in improving this eye condition. Participants will be assigned to receive either T1695 ophthalmic suspension or Ciclosporin ophthalmic emulsion. They will be required to instill the assigned medication as directed. Several diagnostic tests will be performed, including slit lamp examinations, assessment of far best corrected visual acuity (BCVA), and corneal fluorescein staining using a modified Oxford scale. Fluorescein dye will be used to evaluate the corneal staining to measure disease severity and treatment response. Throughout the study, participants will undergo regular eye examinations and visual acuity assessments. The primary outcome is the change in corneal fluorescein staining grade from baseline to Day 29 (Week 4) using the modified Oxford scale. Safety and any adverse effects will be closely monitored during the study period. The total participation age range is from 4 up to 17 years old, with informed consent obtained prior to enrollment.

Researchers are evaluating the safety and effectiveness of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

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.

Long bone defect (LBD) is a focal loss of bone tissue in any long bone of the arms or legs, often caused by trauma, tumors, or infection, with post-traumatic defects being the most common. Limb reconstruction for these defects is complex and currently lacks strong evidence-based treatment guidelines. This international, multicenter registry aims to collect detailed information about the prevalence, treatments, complications, and outcomes of long bone defects over a three-year period. The registry includes any treatment used for long bone defects, with treatment decisions made by individual clinicians based on patient characteristics. No specific treatment is dictated by the registry. The study plans to enroll at least 600 patients from participating sites worldwide. Surgical interventions and other therapies applied to treat bone defects will be documented along with patient-related and other defined outcome measures. Participants will undergo assessments at multiple time points including pre-operative, intraoperative, and follow-up visits up to 12 to 18 months after bone union. These assessments cover baseline characteristics, bone defect details, trauma evaluation, surgical findings, functional outcomes, quality of life, and radiological results. Data collected will help understand treatment strategies, identify challenges, and improve clinical evidence for managing long bone defects.