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Found 5 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.
Actively Recruiting
Researchers are conducting a multicenter, prospective, randomized, double-blind, placebo-controlled Phase 3 study to assess the effectiveness, safety, and tolerability of a single intra-articular injection of PTP-001 (MOTYS) in adults aged 40 to 80 years with knee osteoarthritis. The study focuses on participants with mild to moderate radiographic knee OA and symptomatic knee pain, aiming to compare PTP-001 against a placebo over a 52-week period. Participants will be randomly assigned in equal numbers to receive either a single dose of PTP-001 or a placebo saline injection into the target knee on Day 1. The study includes a screening period up to 28 days before treatment, a one-day treatment phase, and a 12-month follow-up phase. A total of at least 260 participants are planned, with 130 in each treatment group. During the study, participants will undergo evaluations to measure improvements in knee function and pain at 6 months. Researchers will monitor symptoms using pain scales and collect safety data throughout the year. Participants are expected to adhere to study visit schedules, use acetaminophen as needed for knee pain, and avoid other unauthorized medications during the trial.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of a topical gel called zabalafin for treating people with mild to moderate atopic dermatitis, also known as eczema. This Phase 2b study includes two groups: one with mild to moderate atopic dermatitis and another group with mild to moderate atopic dermatitis plus a secondary skin infection. The goal is to compare zabalafin hydrogel against a placebo (vehicle) over a 16-week treatment period. Participants will be randomly assigned to receive either zabalafin hydrogel or a placebo in a 2:1 ratio. The study includes up to 72 participants across 10 sites in Australia. After up to 2 weeks of screening, participants will apply the assigned gel and visit the study site every 2 weeks for the first month, then monthly until the 16-week treatment ends. This double-blind study means neither participants nor researchers know who receives which treatment. During the study, participants will undergo regular evaluations including a clinical assessment using the validated Investigator's Global Assessment scale (vIGA) to measure treatment effects. Researchers will monitor the severity of eczema, skin lesion size, itching intensity, and any side effects. Participants must follow study procedures, including avoiding other topical products on affected skin areas and attending scheduled visits for up to 113 days.
Actively Recruiting
Healthy Volunteer
Researchers are conducting a Phase 1/2 randomized, observer-blinded, dose-escalation trial to evaluate the safety, tolerability, and immune response of an investigational herpes zoster vaccine called Z-1018 compared to the approved Shingrix vaccine. The study involves healthy adults aged 50 years and older, aiming to better understand how these vaccines perform in preventing shingles and related complications. In Part 1 of the trial, about 440 participants aged 50 to 69 years will be randomly assigned to one of ten groups receiving different doses of Z-1018 or to the Shingrix group. Part 2 will enroll approximately 324 participants aged 70 years or older to receive either the selected Z-1018 dose from Part 1 or Shingrix in a 1:1 ratio. Participants receive two vaccine doses, and Part 2 includes extended follow-up for four years after the initial 12-month post-vaccination period to assess long-term immune protection and incidence of shingles and postherpetic neuralgia. Participants will be monitored for local and systemic reactions up to seven days after each dose and adverse events for 28 days post-injection. Serious and medically attended adverse events will be tracked for up to 12 months after the last dose. Immune responses will be measured four weeks after the second dose by vaccine response and antibody levels. Study visits include medical evaluations, laboratory tests, and adherence assessments throughout the trial duration.
Actively Recruiting
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.