Cooper City

Researchers are evaluating tulisokibart as a potential treatment for radiographic axial spondyloarthritis (r-axSpA), a type of arthritis causing pain, stiffness, and inflammation in the spine and pelvis joints, visible on X-rays. This Phase 2b study aims to determine if different doses of tulisokibart improve symptoms better than a placebo, which looks like the study medicine but contains no active drug. The study has two main parts: a 16-week placebo-controlled period where participants receive either tulisokibart or placebo through subcutaneous injections, followed by a 124-week long-term extension divided into a 40-week main extension and an 84-week optional extension. This allows researchers to assess both the short-term and longer-term effects and safety of tulisokibart. Participants will be monitored for their response using the Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 16 as the primary outcome. Throughout the study, researchers will evaluate disease activity and safety while tracking symptoms and any side effects. The total involvement spans up to 140 weeks, including both initial treatment and extension phases.

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis. This Phase 2 study compares ianalumab with a placebo in participants diagnosed according to established classification criteria, focusing on those with active disease and specific autoantibodies. The goal is to better understand ianalumab's impact on this condition over a long treatment period. The study includes several phases: up to 6 weeks for screening, followed by a 52-week initial treatment period where participants receive either ianalumab or placebo by subcutaneous injection. After this, there is a second 52-week open-label treatment period where all participants receive ianalumab. Finally, a post-treatment follow-up period lasts at least 20 weeks and can extend up to 2 years after the last dose. Participants will undergo various assessments throughout the study, including evaluations of their skin condition using the rCRISS25 response at week 52. Safety and tolerability will also be closely monitored. The study involves regular visits for clinical evaluations, laboratory tests, and monitoring of disease activity and antibody status, with the total participation potentially lasting over two years including follow-up.

Researchers are evaluating the safety and effectiveness of brenipatide combined with standard care compared to a placebo with standard care in adults with schizophrenia. This phase 2 study aims to understand how well brenipatide works as an additional treatment for schizophrenia and monitor any side effects. Participants eligible for the study must have schizophrenia and be on stable standard care medication. The trial consists of three main periods: a screening period lasting about one month, a treatment period that can last up to 12 months, and a follow-up period of approximately two months. During the treatment phase, participants receive either brenipatide or placebo administered by subcutaneous injection alongside their standard care. The study includes careful monitoring and adherence to study procedures such as self-injection, keeping diaries, and completing questionnaires. Participants will be involved in regular visits and assessments throughout the entire study duration, which may last up to 15 months. Researchers will measure changes in body weight from baseline to week 52 as a primary outcome. Participants will also be monitored for safety and efficacy through ongoing evaluations, including the use of electronic or paper diaries and required questionnaires to track their progress and response to treatment.

Researchers are investigating the safety and tolerability of LY4213663 in both healthy individuals and people with rheumatoid arthritis (RA). This Phase 1 study aims to understand how the body processes LY4213663 and to monitor any side effects that may occur during treatment. The trial lasts about 33 weeks, not including the screening period. Participants will receive LY4213663 or a placebo through injections either under the skin (subcutaneously) or into a vein in the arm (intravenously). The study includes single and multiple ascending doses for healthy participants and two open-label multiple-dose evaluations for those with RA. Throughout the study, blood tests will be performed to observe the drug's effects and processing by the body. Researchers will carefully watch for any serious side effects related to the study drug from the start until week 33. Participants will be monitored regularly to assess safety and tolerability during the entire study period.

Psoriatic arthritis (PsA) is a long-lasting inflammatory condition that affects the joints and skin in people with psoriasis (PsO). This research aims to evaluate how well the drug zasocitinib (TAK-279) works in adults with active PsA who have not previously used biologic disease-modifying antirheumatic drugs. The study is a Phase 3 clinical trial designed to compare zasocitinib against an active comparator and placebo in this patient group. Participants will receive treatment with either zasocitinib tablets, an active comparator capsule, or a matching placebo. The study includes multiple groups to assess the effects of these treatments. Participants will be followed and treated for up to 60 weeks during the study period. During the study, participants will undergo assessments to measure the percentage achieving improvement according to the American College of Rheumatology 20 (ACR20) response at 16 weeks. Researchers will monitor symptoms, joint and skin involvement, and overall safety throughout the trial. Participants will have regular visits for evaluations and will be observed for treatment effects and any side effects over the full course of the study.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 treatment in adults with primary hypothyroidism who are currently stable on synthetic T4. The study focuses on assessing how well patients respond to dose conversion from synthetic T4 therapy to Armour Thyroid. This trial is conducted as a Phase 2/3 multicenter, double-blind, randomized, active-controlled study. Participants receive either Armour Thyroid in oral capsule or tablet form or synthetic T4 capsules. They must have been on a stable dose of synthetic T4 for at least 12 months before screening, with a dose of at least 25 mcg daily. The study compares both treatments over time to evaluate efficacy and safety in maintaining thyroid function. During the study, researchers monitor thyroid-stimulating hormone (TSH) levels to measure treatment response at week 55. They also track any adverse events related to the treatments for up to approximately 90 weeks. Participants undergo regular assessments to ensure safety and effectiveness throughout the study period.

Researchers are investigating the effects of QCZ484 in patients with mild to moderate hypertension. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy, safety, and pharmacodynamics of QCZ484 compared to a placebo, using various doses administered subcutaneously every 6 months. Participants will receive multiple doses of QCZ484 or a saline placebo through subcutaneous injections over a 12-month treatment period. The study will carefully test different dose levels to identify the optimal dosing strategy for patients with hypertension. Throughout the study, participants will be monitored for changes in their mean 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring at baseline and after 3 months. Safety and tolerability will also be assessed, including regular laboratory tests and clinical evaluations. The trial includes detailed assessments to ensure participants understand and comply with study procedures during the entire duration.

Researchers are investigating the effects of subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adults with knee osteoarthritis (OA) pain. This Phase 3, randomized, double-blind, placebo-controlled study aims to evaluate changes in knee pain and function. The study will enroll approximately 466 participants who meet specific clinical and radiographic criteria for knee OA and have experienced pain despite prior treatments. Participants will be randomly assigned to receive either PPS at a dose of 2 mg/kg or placebo via subcutaneous injections twice weekly for 6 weeks. The study includes a 7-week screening period, followed by the 6-week treatment phase, and a 52-week follow-up period, totaling up to 64 weeks of participation. An interim analysis will be conducted after about half of the participants complete Day 112, with final analysis after all complete Day 404. Throughout the study, participants will attend visits twice weekly during treatment and every 4 to 6 weeks during follow-up. Researchers will assess knee pain using a daily pain rating scale and monitor changes from baseline up to Day 112. Safety and treatment effects will be evaluated through clinical exams, laboratory tests, and imaging as needed. Participants must adhere to stable non-pharmacologic treatments and limit use of certain medications during the trial.

Researchers are evaluating the effectiveness of cadisegliatin as an additional treatment alongside insulin in adults with Type 1 Diabetes Mellitus. This Phase 3 trial focuses on reducing the occurrence of serious hypoglycemia (low blood sugar) events over a 26-week treatment period. The study compares cadisegliatin combined with insulin to a placebo with insulin alone to see if the new treatment lowers the risk of dangerous drops in blood sugar levels. Participants receive either cadisegliatin at a dose of 800 mg once daily, 800 mg twice daily, or a placebo, all as adjunct therapy to their insulin regimen. The study treatment lasts for 26 weeks, during which participants continue their current insulin method, either continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI), without switching. Hybrid closed-loop insulin systems are not allowed. The trial is randomized, double-blind, and placebo-controlled to ensure reliable results. During the study, participants will be monitored for changes in the frequency of Level 2 or Level 3 hypoglycemia events. They must have used a continuous glucose monitoring device for at least three months before screening and maintain stable insulin therapy. Assessments include tracking hypoglycemic episodes, blood glucose levels, and HbA1c values. Safety evaluations and adherence to treatment will be closely observed throughout the 26-week period to understand the impact and safety of cadisegliatin as an adjunct therapy in this population.

Researchers are studying the long-term safety and tolerability of ianalumab in adolescents and adults with moderate-to-severe systemic lupus erythematosus who test positive for anti-nuclear antibodies. This extension study involves participants who previously completed treatment in one of two core SIRIUS-SLE studies. The aim is to monitor how well ianalumab is tolerated over an extended period compared to a placebo. The study compares monthly or quarterly subcutaneous injections of ianalumab to monthly placebo injections. Participants receive these treatments after completing the initial core studies (CVAY736F12301 or CVAY736F12302). This extension phase focuses on continued monitoring of these treatments over a long time frame. Participants will be observed for treatment-emergent adverse events and serious adverse events for up to approximately 91 months. Assessments include monitoring safety and tolerability throughout the study period. The total participation duration depends on individual study completion, with ongoing evaluation to ensure participant well-being during this extended follow-up.