Palm Springs

Researchers are investigating the potential benefits of GB-0895 as an additional treatment for adolescents and adults with severe asthma that remains uncontrolled despite using inhaled corticosteroids and other usual asthma treatments. This global, multicenter Phase 3 trial compares the effects of GB-0895 to a placebo in patients aged 12 to 80 years with severe uncontrolled asthma. The study also includes an optional open-label extension phase to further assess long-term effects and safety. Participants are randomly assigned to receive either GB-0895 or a placebo through subcutaneous injections every 6 months over a 52-week treatment period. Before treatment, there is a screening and run-in phase lasting about 6 weeks. After the 52 weeks of treatment, participants enter a follow-up period lasting up to 38 weeks or may choose to join the optional open-label extension lasting up to 90 weeks, during which they continue receiving GB-0895 at specified intervals. Throughout the study, participants attend visits every 1 to 2 months after the first month to monitor their health and asthma control. Researchers evaluate the annualized asthma exacerbation rate as the main outcome. Safety assessments include physical exams, vital signs, lab tests, and careful monitoring for adverse effects. The study aims to enroll about 786 participants globally to thoroughly assess the safety and effectiveness of GB-0895 as an add-on therapy for severe uncontrolled asthma.

Researchers are evaluating the effectiveness and safety of fusidic acid 1% eye drops compared to a placebo in treating bacterial conjunctivitis in both adults and children. This Phase 3 study aims to show that fusidic acid 1% is superior to placebo for this eye infection, while also establishing its safety when applied directly to the eye. Participants will receive either fusidic acid 1% or a placebo ophthalmic solution as part of a randomized, masked treatment. The study is conducted across multiple centers and includes careful monitoring of treatment effects. The main measure of success is clinical cure assessed on Day 4 after starting treatment. During the study, participants will be closely observed for signs of improvement and safety. They must avoid other ocular treatments, cosmetics, and contact lenses during participation. Researchers will confirm bacterial conjunctivitis through clinical signs and tests to exclude viral causes. The total duration and follow-up procedures are designed to thoroughly evaluate treatment outcomes and safety.

Researchers are evaluating the effectiveness, safety, and tolerability of Suzetrigine in adults with pain caused by diabetic peripheral neuropathy (DPN). This phase 3 study focuses on participants who have had diabetes type 1 or type 2 with bilateral lower limb pain for at least one year and aims to compare Suzetrigine's effects against a placebo. Participants will receive either Suzetrigine tablets or a placebo that looks like Suzetrigine, taken orally. The study is randomized, double-blind, and placebo-controlled, ensuring that neither participants nor researchers know who receives which treatment. The main goal is to measure the change in weekly average daily pain intensity using the Numeric Pain Rating Scale (NPRS) over 12 weeks. During the study, participants will track their daily pain levels to assess treatment effects. Researchers will monitor safety and tolerability throughout the 12-week period, focusing on changes in pain intensity compared to the baseline. Participants must weigh at least 45 kilograms and have a body mass index between 18 and 40 kg/m². The study allows adults aged 18 to 80 years with controlled diabetes and specific pain levels to join.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in patients who have elevated lipoprotein(a) levels and established atherosclerotic cardiovascular disease (ASCVD). It is an open-label, non-randomized rollover extension study involving participants who have completed previous double-blind parent studies related to pelacarsen treatment. Participants will receive pelacarsen 80 mg administered subcutaneously once a month during this extension phase. The study offers continued access to pelacarsen for those who successfully finished the parent studies, allowing researchers to monitor its effects over a longer period. Throughout the study, participants will be monitored for adverse events and serious adverse events for up to 48 months. Researchers will assess safety and tolerability through ongoing evaluations, ensuring continuous observation of participants' health and responses to the treatment during this extended timeframe.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.