Tarragindi

Researchers are evaluating the use of PTP-001 MOTYS, an allogeneic human placental tissue particulate, for treating knee osteoarthritis OA. This Phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the safety, tolerability, and effectiveness of a single injection of PTP-001 compared to placebo over a 52-week period in adults aged 40 to 80 with symptomatic and radiographically confirmed knee OA. Participants will be randomly assigned to receive one injection into the target knee of either 200 mg PTP-001 or 4 mL of placebo saline solution. The study includes a screening period lasting up to 28 days before treatment, a one-day treatment phase when the injection occurs, and a follow-up phase of 12 months to monitor outcomes and safety. Approximately 260 participants will be enrolled, with 130 in each treatment group. During the study, participants will undergo assessments at multiple time points, including evaluations of knee pain and function using standardized scales such as WOMAC and patient global assessments. The main outcomes focus on the proportion of participants showing strict improvement in knee pain and function at 6 months, with additional measurements at 9 and 12 months. Safety and tolerability will also be monitored throughout the follow-up period.

Researchers are evaluating the effectiveness of zabalafin hydrogel in people aged 2 years and older who have mild to moderate atopic dermatitis, also known as eczema. This Phase 2b randomized, double-blind study includes two groups one with mild to moderate atopic dermatitis and another with the same condition plus a secondary skin infection. The study aims to compare zabalafin hydrogel to a placebo vehicle to understand its impact on eczema symptoms using a validated global assessment scale. Participants will be randomly assigned in a 21 ratio to receive either zabalafin 9.5% hydrogel or a placebo gel. The study treatment lasts 16 weeks following up to 2 weeks of screening. During treatment, participants will visit the clinic every 2 weeks for the first month and then monthly until the end of the study. The study evaluates not only the effectiveness but also the safety and tolerability of zabalafin compared to the placebo. Throughout the study, participants will undergo assessments including the validated Investigators Global Assessment, Eczema Area and Severity Index, pruritus itching rating, and patient-reported eczema measures. Safety monitoring and evaluation of antibacterial effects in those with skin infections are included. Participants must comply with study procedures, avoid using other topical products on the eczema lesions, and attend scheduled visits over the approximately 16-week treatment period.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.