Slidell

Researchers are investigating how bone mineral density changes during long-term treatment with the relugolix combination tablet in premenopausal women aged 18 to 50 who have heavy menstrual bleeding caused by uterine fibroids or moderate to severe pain related to endometriosis. This Phase 3B, single-arm, open-label study aims to assess the safety and effects of up to 48 months (4 years) of continuous treatment, followed by a 1-year post-treatment follow-up period. Participants will receive a daily fixed-dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg. Bone mineral density will be monitored every 6 months using dual-energy X-ray absorptiometry during treatment. Some women who completed a prior related study may join for 3 years of treatment under this protocol. After treatment ends or if stopped early, participants will be followed for 1 year with bone density checks at 6 and 12 months. Women in the study will have regular physical, gynecological, and laboratory assessments to monitor health and treatment effects. Researchers will measure the percentage change from baseline in bone mineral density at the lumbar spine after 48 months of treatment. Safety and health status will be closely observed throughout the treatment and follow-up periods to understand the long-term impact of the relugolix combination tablet on bone health.

Researchers are evaluating the safety, tolerability, and biomarker effects of VS-041 in adults aged 50 years and older who have Heart Failure with Preserved Ejection Fraction (HFpEF). This phase 1 trial focuses on participants diagnosed according to established criteria and classified as NYHA Functional Class II or III, with specific heart function and biomarker thresholds. The study aims to better understand how VS-041 works in this population by monitoring heart-related biomarkers and side effects over time. Participants will receive either a high dose or low dose of VS-041, or a matching placebo tablet, taken twice daily. The study treatment lasts for 28 days, during which researchers will track changes in specific blood biomarkers such as NordicPRO-C6, endotrophin, and NT-proBNP. These biomarkers help measure the heart condition and response to the treatment. The trial includes careful dosing and monitoring to assess safety and tolerability. During the study, participants will undergo regular assessments to check for any treatment-emergent adverse events and changes in biomarker levels from baseline up to day 28. The evaluations may include blood tests and clinical exams to monitor heart function and overall health. Participants are required to maintain stable doses of their usual heart failure medications and comply with trial procedures for the entire duration. The total participation period is focused on the 28-day treatment and observation window.

This research evaluates the effects of empasiprubart compared to intravenous immunoglobulin (IVIg) in adults diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition affecting the nerves. The study is a Phase 3 trial aiming to assess the safety and effectiveness of these treatments. Participants must meet specific CIDP diagnostic guidelines and have shown response to IVIg in the past five years. The study is divided into two parts. In Part A, lasting 24 weeks (6 months), participants receive either empasiprubart with a placebo mimicking IVIg, or IVIg with a placebo mimicking empasiprubart. Following this, Part B lasts 96 weeks (24 months), during which all participants receive empasiprubart. Both treatments are given by intravenous infusion. Placebos are used to maintain blinding in the study. Participants will be monitored for changes in their disease symptoms, particularly focusing on improvements measured by a reduction of at least 1 point in the adjusted inflammatory neuropathy cause and treatment (aINCAT) score by week 24. Throughout the study, safety and disease activity will be regularly assessed. The total study duration for participants is up to 120 weeks, including both treatment parts.

Researchers are evaluating the safety and effectiveness of empasiprubart in adults diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This phase 3 study aims to compare empasiprubart with a placebo in treating this condition, which involves nerve inflammation and damage that can cause weakness and disability. Participants include adults with typical CIDP or certain CIDP variants who have active disease and residual disability. The study has two parts: In part A, participants receive either empasiprubart or a placebo through intravenous infusion for 24 weeks (6 months). After this, all participants enter part B, where everyone receives empasiprubart intravenously for an additional 96 weeks (24 months). This design allows researchers to observe both the initial effects compared to placebo and the longer-term outcomes of empasiprubart treatment. Throughout the study, participants will be regularly monitored for treatment effects and safety. The main outcome measured is the reduction of at least 1 point in the adjusted inflammatory neuropathy cause and treatment (aINCAT) score by week 24. Researchers will also track any side effects and overall health during the full duration of the study, which can last up to 2.5 years including both parts A and B.

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 use of baloxavir marboxil in children under 12 years old with influenza. This study has two parts: Part A focuses on checking for resistance-related changes in the virus before and after treatment, while Part B looks at how influenza might spread from young children treated with baloxavir marboxil to their household contacts. Enrollment for Part B has stopped as per the latest protocol. Baloxavir marboxil is given as an oral suspension, with the dose based on the child's body weight: 80 mg for those 80 kg or more, 40 mg for 20 to less than 80 kg, and 2 mg per kg for those under 20 kg. Part A involves monitoring these children for resistance changes at baseline and during treatment on specific days. Part B included participants from Part A who lived with household contacts, assessing transmission, but no new participants are being enrolled in this part. Participants will be involved in screening to confirm influenza and absence of COVID-19, with symptom onset within 48 hours before starting treatment. Researchers will measure resistance-associated viral changes at baseline and during treatment days 4, 6, and 10. Household contacts in Part B were also assessed for influenza transmission risk and monitored through scheduled visits, but Part B enrollment is closed. The total study duration varies depending on participation in Parts A and B.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of CK-4021586 in adults aged 40 to 85 years with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF). This Phase 2 dose-finding study focuses on participants who have NYHA functional class II or III heart failure and a left ventricular ejection fraction (LVEF) of 60% or higher. The study aims to gather important data on the drug's effects and safety profile in this specific heart condition. Participants will receive either oral CK-4021586 at doses of 150 mg, 300 mg, 450 mg, or 600 mg, or a matching placebo. Stable doses of background medications such as beta-blockers, ACE inhibitors, ARBs, or ARNIs are required before the study, as well as stable use of GLP-1 agonists if applicable. The study is randomized, double-blind, and placebo-controlled, ensuring rigorous comparison between the investigational drug and placebo groups. During the 12-week study period, participants will be monitored for early drug discontinuation, heart function changes indicated by LVEF falling below 40%, and the occurrence of adverse events. Evaluations include echocardiography, laboratory tests for NT-proBNP levels, and ongoing safety assessments. This careful monitoring helps researchers understand the treatment's safety and tolerability in people with HFpEF over the study duration.

Researchers are evaluating the safety and effectiveness of VIA Disc NP, a non-surgical treatment designed to supplement damaged nucleus pulposus tissue in people with lumbar discogenic pain linked to degenerative disc disease (DDD). This randomized, sham-controlled, multi-center, double-blind clinical trial includes an open-label roll-in period with one participant per site. The study focuses on adults aged 22 to 85 years who have moderate to severe DDD and chronic low-back pain that has not improved with conservative care. Participants will receive one VIA Disc NP treatment per affected disc level, up to two levels. Those enrolled after the roll-in phase will be randomly assigned in a 2:1 ratio to either the VIA Disc NP intradiscal injection or a sham procedure that mimics the injection without penetrating the disc. Participants in the sham group who continue to experience symptoms after 12 months may cross over to receive VIA Disc NP and will follow an additional 12 months of study visits. During the study, participants will undergo assessments including pain severity and disability scores, physical tests, and imaging to monitor the treatment's effects and safety. Researchers will track the proportion of participants achieving meaningful pain improvement and report any treatment-related adverse events over 12 months. Those crossing over will be monitored for an additional year, ensuring close safety follow-up and evaluation of long-term outcomes.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are investigating the effectiveness and safety of a single injection of rexlemestrocel-L combined with hyaluronic acid (HA) in adults with moderate to severe chronic low back pain due to degenerative disc disease. This Phase 3 study aims to compare this treatment to a control to see if it reduces low back pain at 12 months after treatment, while also monitoring safety outcomes up to 24 months. Participants will receive either an injection of a mixture of rexlemestrocel-L and HA directly into the lumbar intervertebral disc or a saline injection near the affected disc. The rexlemestrocel-L and HA are mixed in equal volumes and administered as an intradiscal injection. The study is randomized, double-blind, and controlled to ensure unbiased assessment of treatment effects. During the study, participants will be monitored for changes in their average daily low back pain using a visual analog scale from baseline to 12 months after treatment. Researchers will also record any adverse events or serious adverse events occurring up to 24 months post-treatment. Participants will undergo regular evaluations, including clinical assessments, to track pain levels and safety throughout the study period.