Weonju

Researchers are conducting a 24-week, prospective, open-label, multicenter, single-arm study to observe the safety and effectiveness of Atectura inhalation capsules in patients with asthma. This study is non-interventional and takes place in real-world clinical settings in Korea, following routine practice without additional diagnostic or monitoring procedures beyond standard care. Participants will use one of three available doses of Atectura inhalation capsules (150/80ug, 150/160ug, or 150/320ug) delivered via Breezhaler as prescribed according to approved label information. Patients already prescribed Atectura before joining the study will be enrolled, and no treatment allocation or changes will be made by the study team. During the 24-week period, researchers will monitor for any adverse events, including serious and unexpected ones, to assess safety. Data collection will include participant consent and follow-up as per routine practice, focusing on real-world use and outcomes of Atectura in asthma management.

Researchers are conducting a 24-week observational study to monitor the safety and effectiveness of the Enerzair inhalation capsule in adults with asthma under routine clinical care. This study is prospective, open-label, multicenter, and single-arm, designed to gather real-world data without altering standard treatment practices. The goal is to evaluate how Enerzair performs in everyday use over nearly six months. Participants in this study will be adults with asthma who have already been prescribed one of two doses of Enerzair inhalation capsules via Breezhaler, following approved labeling in Korea. The two dosages used are 150/50/80 micrograms and 150/50/160 micrograms. There is no treatment assignment by the study; instead, patients continuing their prescribed Enerzair treatment will be observed. No additional diagnostic tests or monitoring beyond routine clinical care will be performed. During the 24-week study, researchers will track any adverse events or serious adverse events, including unexpected ones, to assess safety. Participants will provide informed consent for data collection. The study will observe patients through their usual care visits, focusing on safety outcomes without additional interventions or procedures. This real-world surveillance helps understand Enerzair's tolerability and safety profile over six months in a broad adult asthma population.

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are evaluating the long-term safety and effectiveness of TAK-279 (also called Zasocitinib) in adults with moderately to severely active Crohn's Disease or Ulcerative Colitis, which are serious inflammatory bowel diseases causing pain and swelling in the intestines. This study is an extension of two earlier phase 2 trials where participants who responded to TAK-279 may continue to receive treatment. The goal is to understand how well TAK-279 controls bowel inflammation and symptoms when used for up to two years. Participants will receive oral Zasocitinib capsules for up to 108 weeks. During this time, they will attend 11 visits at their study clinic for treatment and monitoring. This open-label extension study focuses on long-term safety, tolerability, and sustained response in those who showed improvement in the initial parent trials. Throughout the study, researchers will track the number of participants experiencing treatment-related side effects, significant changes in vital signs, lab tests, and ECG results. Participants' symptoms and inflammation will be regularly assessed to monitor TAK-279's ongoing effects. The study includes safety monitoring from the start of treatment to week 112, with careful attention to any adverse events or important changes in health measurements.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are studying the safety, tolerability, and effects of NS101, an anti-FAM19A5 antibody, in healthy volunteers and patients with sudden sensorineural hearing loss (SSNHL). The trial aims to find out if NS101 is safe and tolerable when taken in multiple doses and whether it can improve hearing in SSNHL patients who have not sufficiently recovered after standard steroid treatment. This study is conducted in two phases, Phase 1b and Phase 2a, and is placebo-controlled and double-blinded to ensure unbiased results. Participants receive NS101 at doses of either 15 mg/kg or 30 mg/kg, administered systemically for less than three months according to the study protocol. There is a placebo group receiving a fake drug without the active ingredient for comparison. The study is designed in two steps to explore safety, pharmacokinetics, pharmacodynamics, and efficacy of NS101 as an early salvage therapy for SSNHL. Throughout the study, participants undergo frequent safety assessments at specified time points from baseline through several weeks, depending on the phase they are in. These include monitoring for side effects and changes in safety profiles. Researchers measure hearing improvement, tolerability, and drug effects using various clinical evaluations. The total age range for participants is from 19 to 70 years, and the study carefully monitors both healthy volunteers and SSNHL patients over the treatment period.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

This research aims to assess the safety and effectiveness of Jakavi4 (ruxolitinib) in patients with steroid-refractory Graft-versus-Host Disease (GvHD) in Korea. It is designed as a prospective, open-label, multi-center, non-comparative observational study focusing on real-world clinical use of this medication. The study includes patients newly starting Jakavi4 as well as those already taking it prior to joining the study. Participants will receive ruxolitinib as prescribed by their doctors following the approved local guidelines. There is no treatment assignment by the study; patients are observed while taking the medication in the commercial setting. The treatment period will be monitored for up to 24 weeks, with dosing and duration determined by the treating physician. During the study, researchers will closely monitor participants for adverse events and treatment safety throughout the 24-week treatment period and an additional safety follow-up after the last dose. Effectiveness and durability of the treatment will also be assessed. Participants' safety data, including any serious or unexpected reactions, will be collected to evaluate the overall safety profile of ruxolitinib in this patient group.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

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.