Kotara

Researchers are investigating the safety, tolerability, pharmacokinetics, and effectiveness of the drug IG3018 in people with high uric acid levels hyperuricemia, including those with and without chronic kidney disease CKD. This phase III clinical trial aims to better understand how IG3018 works in these groups and to explore appropriate dosing. The study is sponsored by Intelligem Therapeutics Australia Pty Ltd and includes participants aged 18 to 75 years. The trial has two parts. Part 1 is a randomized, double-blind, placebo-controlled dose escalation study in participants without CKD, testing increasing doses of IG3018 tablets 0.25 g, 0.5 g, and 1.0 g. Each dose cohort receives a single dose followed by four weeks of twice-daily maintenance dosing. Part 2 is an open-label study in participants with advanced predialysis CKD Stages 3a, 3b, and 4, who receive either 0.5 g or 1.0 g of IG3018 twice daily for four weeks. Participants will attend study visits for blood and urine sample collection to analyze drug levels and kidney function. Safety and efficacy will be assessed through laboratory tests, gout attack monitoring, and uric acid measurements over about 46 days. The study tracks changes in serum uric acid levels, kidney function markers, and drug pharmacokinetics. Participants must provide consent and follow study procedures throughout the treatment and monitoring periods.

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Researchers are evaluating the safety and efficacy of FB102, an intravenous drug, in patients with non-segmental vitiligo. This randomized, double-blind, placebo-controlled, multi-center Phase 1 study aims to better understand how FB102 may affect skin pigmentation in adults aged 18 to 75 years who have this condition. Approximately 64 participants will take part in the trial sponsored by Forte Biosciences, Inc. Participants will be randomly assigned to receive either FB102 or a matching placebo, both given through intravenous infusion. The treatment period lasts up to 16 weeks after the first dose administration. During this time, the study will closely monitor participants receiving these treatments to compare their effects on vitiligo. Participants will undergo regular assessments including facial and total vitiligo area scoring indexes to measure changes in skin pigmentation. Safety will also be evaluated by tracking treatment-emergent and serious adverse events. The study includes scheduled visits and evaluations up to 16 weeks post-treatment. This allows researchers to gather detailed information on the drugs impact and participant safety throughout the study period.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

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 the safety and effectiveness of ABP-745 in people experiencing an acute gout flare. This Phase 2, randomized, double-blind, international, multicenter study compares ABP-745 to standard colchicine treatment and placebo. The goal is to see how well ABP-745 reduces pain and swelling during a gout flare, with the main measure being the pain score after treatment. Participants will be randomly assigned to one of four groups two different doses of ABP-745 with a colchicine placebo, standard colchicine treatment with an ABP-745 placebo, or a placebo for both drugs. All treatments are given as tablets by mouth. The study will monitor participants from the first dose through up to 14 days to assess pain changes and any side effects. During the study, participants will have their pain measured using a visual analog scale at various times, including 24 hours and up to 8 days after the first dose. Researchers will also track any treatment-related adverse events for up to two weeks. Participants must maintain stable lifestyle habits and medication doses during the study. The total study duration and follow-up include safety assessments to understand the effects and tolerability of the treatments.

Researchers are studying the safety of BHV-1300 as a treatment for adults with Graves Disease. This Phase 1 trial aims to explore how BHV-1300 affects biomarkers related to this condition to better understand its impact. The study is led by Biohaven Therapeutics Ltd. and focuses on monitoring the treatments safety profile over time. Participants will receive BHV-1300, which is given as a subcutaneous injection. This open-label study does not include placebo control or blinding, and all participants receive the same treatment. The treatment period and follow-up extend up to 52 weeks to observe effects and any adverse events. During the study, participants will be closely monitored for serious adverse events, side effects that may lead to stopping treatment, and laboratory abnormalities. Researchers will regularly assess health status and collect data on disease-specific biomarkers. The total duration of participation is approximately one year, ensuring comprehensive safety and effect evaluations.

Researchers are studying an Acne mRNA vaccine candidate to evaluate its safety, effectiveness, and immune response in adults aged 18 to 45 years with moderate to severe acne. This first-in-human Phase III trial aims to find the best vaccine dose and regimen by testing four different doses and comparing two versus three injections. Acne is a common inflammatory skin disease, and current treatments have not changed much in 30 years, so new options are needed. The trial includes a Core Study with four cohorts two cohorts receive two doses Sentinel Cohort A and Main Cohort A and two cohorts receive three doses Sentinel Cohort B and Main Cohort B. The vaccine or placebo is given by intramuscular injection. After completing the Core Study, some participants will join a Long-Term Extension LTE follow-up lasting up to 30 months to assess lasting effects. Participants in the Main Cohort B may join a separate LTE study. During the study, participants will have medical exams, blood tests, and acne lesion counts. Researchers will monitor adverse events shortly after each injection and for up to 6 or 9 months after. They will measure changes in inflammatory and non-inflammatory acne lesions and antibody levels. Safety assessments include monitoring serious and unexpected reactions. Follow-up visits will continue for months after the last dose to observe long-term safety and immune response.