Euijeongbu

Researchers are evaluating the safety and effectiveness of an injectable device called ALLOHEAL for patients with knee osteoarthritis. This study compares ALLOHEAL, which contains sodium polynucleotide, chitosan, and type I collagen, to a control device named Conjuran®. The goal is to see if ALLOHEAL is not worse than Conjuran® in reducing mechanical friction inside the knee joint and easing pain, measured primarily by the Visual Analog Scale (VAS) over six months. Participants receive intra-articular injections of either ALLOHEAL or Conjuran® into their affected knee. The study assesses pain and joint function at multiple points: 6, 10, 16, and 24 weeks after the first injection. The follow-up period is designed to gather safety information, especially concerning the additional components chitosan and collagen in ALLOHEAL. During the trial, participants will attend scheduled visits for evaluations including pain measurement using VAS, clinical assessments, and safety monitoring. Researchers will track changes in knee pain from baseline to 6 months. Participants remain in the study for about 24 weeks to allow thorough assessment of treatment effects and safety.

Researchers are studying adults with confirmed Primary Biliary Cholangitis (PBC) and cirrhosis, a scarring of the liver caused by damage to bile ducts. PBC is a slowly progressing disease that causes bile acid buildup and further liver damage, which can lead to cirrhosis. This study aims to evaluate if elafibranor, a daily medication, can prevent worsening clinical outcomes such as the need for liver transplant or death, compared to a placebo. It also looks at the safety of long-term elafibranor use and its effect on symptoms like itching and tiredness. Participants will take either an 80 mg tablet of elafibranor or a matching placebo once daily for up to 3.5 years in a double-blind setup, meaning neither the participants nor researchers know who receives which treatment. This long-term treatment period is designed to monitor the drug's impact over time. The study includes two groups: one receiving elafibranor and the other receiving placebo, with treatment lasting up to approximately 42 months. During the study, participants will be regularly assessed from the start until 4 weeks after treatment ends, with a maximum involvement of 3.5 years. Researchers will measure event-free survival, tracking if participants avoid clinical events indicating disease worsening. Safety monitoring will include tracking side effects and overall health, while symptom impact will be evaluated. Participants will provide informed consent and follow the study protocol throughout this extended observation period.

Researchers are evaluating the safety, tolerability, how the body processes, and effectiveness of TERN-701, a selective allosteric inhibitor targeting BCR-ABL1, in adults with chronic phase chronic myeloid leukemia (CP-CML) who have been previously treated. The study is divided into two parts: Part 1 focuses on dose escalation to find safe dosage levels, and Part 2 involves randomized dose expansion to further assess the chosen doses and includes a mutation cohort for participants with certain resistance mutations. Participants in both parts will take TERN-701 orally once daily in 28-day cycles. Part 1 involves sequential dose escalation cohorts, while Part 2 evaluates two recommended dose levels selected from Part 1. The mutation cohort (Part 2m) will assess a specific 500 mg dose in participants with particular resistance mutations. Scheduled visits occur frequently during the first treatment cycle and then regularly throughout the study to monitor treatment effects. During the study, participants will have regular visits for evaluations including safety checks and laboratory tests. Researchers will measure dose-limiting toxicities, adverse events, hematologic response, molecular response, and changes in BCR-ABL1 transcript levels up to three years. The trial plans to enroll about 180 participants, with up to 80 in Part 1, about 80 in Part 2, and around 20 in the mutation cohort. All participants will receive the active treatment throughout the study duration.

Researchers are evaluating the safety and effectiveness of Radotinib in patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia (CP-CML) who have not responded well or cannot tolerate previous treatments with tyrosine kinase inhibitors (TKIs) including Imatinib. This Phase 3, multinational, multicenter, open-label study aims to enroll 173 participants to better understand Radotinib's impact on this condition. Participants will receive Radotinib capsules at a dose of 400 mg twice daily in a single treatment arm. Radotinib is provided as hard capsules containing 100 mg or 200 mg doses of the drug. Treatment will be administered continuously, and the study includes monitoring for safety and efficacy throughout the course. The study does not include a comparator group but follows participants closely for response to therapy. During the study, participants will be regularly evaluated to monitor their response, including measuring the major cytogenetic response at 6 months. Assessments will include laboratory tests to check organ function and disease status, as well as safety monitoring for side effects. The study requires participants to attend scheduled visits and comply with study procedures, including pregnancy testing for women of childbearing potential and contraception use. The overall participation duration and follow-up details are based on the study protocol.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effectiveness and safety of brenipatide compared to a placebo in adults with Alcohol Use Disorder (AUD) and hazardous alcohol use. This Phase 3, multicenter, randomized, double-blind study aims to understand if brenipatide can help participants reduce or stop drinking. The study lasts approximately 56 weeks and focuses on changes in drinking patterns using the Timeline Followback Method (TLFB). Participants will receive either brenipatide (LY3537031) or a placebo, both administered by subcutaneous injection. Participants who cannot self-inject will have assistance from a trained support person. They are expected to store and use the blinded study drug as directed, maintain electronic and paper diaries, and complete questionnaires throughout the study. During the study, participants will have scheduled visits to monitor their progress, including assessments of drinking behavior and safety evaluations. Researchers will measure changes in alcohol use patterns up to 56 weeks. Participants must be motivated to reduce or stop drinking and be available for all study visits and procedures. Safety and adherence will be closely monitored throughout the trial.

Researchers are evaluating the safety and effectiveness of brenipatide compared to a placebo for adults with moderate-to-severe Alcohol Use Disorder (AUD). This phase 3 study aims to better understand if brenipatide can help reduce drinking in this population. Participants will be followed for about 56 weeks to gather comprehensive information. Participants will receive either brenipatide (LY3537031) or a placebo, both given by subcutaneous injection. The study involves a randomized, double-blind design, meaning neither the participants nor the researchers know who receives which treatment during the trial. This method helps provide reliable results about the effects and safety of brenipatide. During the study, participants will attend scheduled visits, self-inject the study drug, and complete electronic and paper diaries as well as questionnaires. Researchers will monitor changes in drinking patterns using the Timeline Followback Method for up to 56 weeks. Safety monitoring and regular assessments will be performed throughout the study to track participants' health and adherence.

This research aims to collect and evaluate safety and effectiveness information about Jyseleca tablet (Filgotinib Maleate) at doses of 100 mg and 200 mg in Korean adults with rheumatoid arthritis or ulcerative colitis. The study focuses on tracking serious adverse events, adverse drug reactions, unexpected events, and other safety-related issues during real-world use following marketing approval in Korea. Participants will not receive any interventions as this is a non-interventional observational study. The study observes patients being treated with Jyseleca according to the Korean approved label, which includes adults with moderately to severely active rheumatoid arthritis or ulcerative colitis who have not responded well or are intolerant to prior therapies. The medication may be used alone or with methotrexate in rheumatoid arthritis, but not with biological DMARDs or other JAK inhibitors. During the study, participants will be monitored for safety outcomes such as serious and non-serious adverse events and adverse drug reactions up to 24 weeks after enrollment. Effectiveness measures include changes in disease activity scores for rheumatoid arthritis and ulcerative colitis at 12 and 24 weeks. Researchers will collect and evaluate all safety and efficacy-related information under typical use conditions in Korea.

Researchers are conducting a global Phase 3 study to compare the effectiveness and safety of olverembatinib combined with chemotherapy versus the investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in patients newly diagnosed with Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL). This study aims to evaluate these treatments in a randomized and open-label setting to determine the best approach for this condition. Participants will receive treatment in one of two groups: one group will take olverembatinib orally every other day along with chemotherapy, while the other group will receive an investigator-chosen TKI orally once daily combined with chemotherapy. Both treatments are studied over cycles of 28 days, focusing on the initial three cycles for measuring response. During the study, participants will be monitored for treatment effects, including the rate of minimal residual disease negative complete remission from cycles 1 to 3. Researchers will assess safety, treatment adherence, and any side effects. The study includes various evaluations to ensure participant health and treatment effectiveness over the course of therapy.

Researchers are evaluating the safety and effectiveness of vutiglabridin in patients with early Parkinson's disease. This Phase 2a trial follows earlier Phase 1 studies that assessed the safety, tolerability, and pharmacokinetics of vutiglabridin in healthy volunteers. The study is a randomized, double-blind, placebo-controlled trial designed to compare vutiglabridin against a placebo in adults diagnosed with early-stage Parkinson's disease. Participants will be randomly assigned to one of three groups in equal proportions: two groups receiving different doses of vutiglabridin and one group receiving a placebo. All treatments will be taken once daily by mouth for 24 weeks. The trial will evaluate several measures including motor symptoms, clinical global impressions, non-motor symptoms, disease stages, and dopamine transporter imaging to assess efficacy. Safety will be monitored through vital signs, ECGs, laboratory tests, pregnancy tests, physical exams, and adverse event tracking. Blood samples will also be collected to study how the drug is processed in the body. Throughout the study, participants will undergo regular assessments of their Parkinson's disease symptoms and overall health. These include standardized rating scales for motor function, clinical evaluations, and imaging tests. Researchers will monitor safety continuously and track any side effects or adverse events during the 24-week treatment period. The main outcome measured is the change from baseline in motor symptoms after 24 weeks of treatment. This comprehensive monitoring aims to understand the effects and safety of vutiglabridin in early Parkinson's disease.