Cooper City

Researchers are investigating new treatments for radiographic axial spondyloarthritis r-axSpA, a form of arthritis causing pain, stiffness, and swelling in the spine and pelvis joints. This condition shows visible damage on X-rays. The study aims to evaluate if different doses of the medicine tulisokibart can improve r-axSpA symptoms compared to a placebo, which helps measure the medicines effects accurately. Participants will be assigned to one of several groups receiving high, medium, or low doses of tulisokibart, or a placebo. The study includes a 16-week placebo-controlled phase. After that, participants receiving the low dose or placebo will be re-assigned to medium or high doses. Following this, there is a long-term extension lasting 124 weeks, which has a 40-week main extension and an 84-week optional extension, allowing continued treatment and observation. Throughout the study, participants will have regular assessments to monitor symptoms and disease activity using various indexes and imaging scores. Researchers will track the percentage of participants who achieve improvement at week 16 and monitor safety by recording adverse events up to approximately 154 weeks. The study uses injections of tulisokibart or placebo under the skin and includes ongoing evaluations of physical function, pain, inflammation, and quality of life.

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis, a condition characterized by skin thickening and other systemic symptoms. This Phase 2 study compares ianalumab to a placebo to understand its impact on this disease, aiming to provide new treatment options for affected individuals. The study is sponsored by Novartis Pharmaceuticals and employs a randomized, double-blind design to ensure reliable results. Participants receive either ianalumab or placebo through subcutaneous injections during the initial 52-week treatment period. After this, all participants enter a second 52-week open-label phase where they receive ianalumab. Following treatment, there is a post-treatment follow-up lasting at least 20 weeks and up to 2 years to monitor long-term effects. The study includes a screening period lasting up to 6 weeks before treatment begins. Throughout the study, participants undergo regular assessments including measuring response based on the rCRISS25 scale at Week 52, lung function tests, skin scoring, and disability index evaluations. Blood samples are taken periodically to measure drug levels and antibodies. Safety is closely monitored through adverse event reporting up to Week 208. The total participation time can extend over several years including treatment and follow-up phases.

Researchers are evaluating the effectiveness and safety of brenipatide combined with standard care compared to a placebo plus standard care for treating schizophrenia in adults aged 18 to 55. This phase 2 clinical trial aims to better understand how brenipatide works alongside existing treatments in this population. Participants are randomly assigned to receive either brenipatide or placebo, both administered by subcutaneous injection, alongside their usual standard of care medications. The study includes a screening period lasting about one month, followed by a treatment period that can last up to 12 months, and then a follow-up period of approximately two months. During the trial, participants will attend scheduled visits to monitor their health, complete questionnaires, and maintain diaries about their medication use. Researchers will measure changes in body weight, neurocognitive function, schizophrenia symptom severity, and other clinical assessments. Safety is closely monitored throughout, and the total participation time may last up to about 15 months.

Researchers are investigating the effects of enpatoran in adults with active cutaneous lupus erythematosus, with or without systemic lupus erythematosus SLE. This global, multicenter Phase 3 study aims to evaluate the efficacy and safety of enpatoran over a 24-week treatment period, focusing on skin manifestations of lupus. The study is designed as a randomized, double-blind, placebo-controlled trial to assess how well enpatoran works alongside standard care in this population. Participants will receive either enpatoran tablets or placebo tablets twice daily for 24 weeks while continuing their investigator-recommended standard of care. Dosing occurs orally from Day 1 to Day 168. Visits are scheduled every four weeks, except for a televisit at Week 2. The study includes treatment and follow-up visits throughout the treatment period, which lasts up to 35 weeks in total. During the study, participants will undergo regular assessments including evaluation of skin disease severity using the Cutaneous Lupus Erythematosus Disease Area and Severity Index CLASI, and other lupus activity measures. Safety will be monitored by tracking adverse events and laboratory results. Researchers will also assess symptoms such as itch and skin changes. The main outcome is the reduction of skin disease severity at Week 24. Participants may expect scheduled clinic visits and evaluations over the study course until completion in May 2029.

Researchers are evaluating the safety, tolerability, and how the body processes LY4213663 in healthy adults and adults with rheumatoid arthritis RA. This Phase 1 study aims to understand potential side effects and how the drug behaves when given by injection under the skin or into a vein. The study includes both healthy participants and those diagnosed with RA, with a focus on basic science aspects of the treatment. The study involves several parts single-ascending doses a gradually increasing dose and multiple-ascending doses of LY4213663 or placebo given either subcutaneously or intravenously in healthy participants. In participants with RA, multiple doses of LY4213663 are given by these two methods. The study design includes randomized assignments to drug or placebo groups for the healthy participant parts, while the RA participant parts are open-label. The entire study lasts about 33 weeks, excluding screening. Participants will have blood tests to check drug levels and effects, as well as monitoring for any serious side effects related to the drug. Researchers will assess safety throughout the study by tracking adverse events. The study measures how much LY4213663 is in the blood over time and its maximum concentration. Participants will attend regular visits for dosing and assessments during the study period, which runs from screening through to the last follow-up around 33 weeks after dosing begins.

Psoriatic arthritis PsA is a chronic inflammatory condition that affects the joints and skin in people with psoriasis. This study aims to evaluate how well zasocitinib TAK-279 works in adults with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The trial is a Phase 3, randomized, double-blind study comparing zasocitinib with an active comparator and placebo. Participants will be assigned to one of four groups zasocitinib Dose A once daily, zasocitinib Dose B once daily, an active comparator capsule twice daily, or placebo once daily for 16 weeks followed by switching to zasocitinib Dose A or B up to 52 weeks. Treatments are taken orally as tablets or capsules over a period of up to 60 weeks. During the study, participants will undergo regular assessments including joint counts, skin evaluations, and various disease activity measurements such as ACR20 and PASI-75 responses. Researchers will monitor changes from baseline in functional and quality of life scores, as well as safety and tolerability. Participants will be involved in visits throughout the treatment period to evaluate the effects and collect data on the disease and treatment responses.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 in adults with primary hypothyroidism who have been stable on synthetic T4 treatment. The study will also assess how well patients tolerate switching from synthetic T4 to Armour Thyroid. This trial is a Phase 23, randomized, double-blind study sponsored by AbbVie to compare these two thyroid hormone replacement therapies. Participants will be randomly assigned to receive either Armour Thyroid or to alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. The treatments are oral capsules or tablets taken daily, with doses carefully converted from their stable synthetic T4 dose. The study includes a dose-conversion period where dosage adjustments may be made to maintain appropriate thyroid hormone levels. During the study, participants will have regular blood tests to measure thyroid-stimulating hormone TSH levels, including at week 55 to see who achieves a target TSH response. Researchers will also monitor for any adverse events throughout the study, which lasts up to about 90 weeks. Dose adjustments and safety data will be tracked closely to understand treatment effects and tolerability over time.

Researchers are conducting a multicenter, randomized, double-blind Phase 2 study to evaluate the pharmacodynamics, safety, and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484 alone, inclisiran alone, and placebo in adults with hypertension and hypercholesterolemia. The study focuses on understanding how these treatments affect certain blood markers and blood pressure in this population. Participants receive a single dose of either the combination of QCZ484 and inclisiran, QCZ484 alone, inclisiran alone, or placebo on Day 1. The study lasts up to 12 months and includes a screening period with two visits to confirm eligibility, followed by the treatment administration at the baselinerandomization visit. After treatment, participants enter a safety follow-up phase, with an option to join an open-label extension study instead of the follow-up. During the study, participants undergo various assessments including measurements of PCSK9 and AGT levels at baseline and Month 3, blood pressure and LDL cholesterol levels at baseline, Month 3, and Month 6, along with monitoring for treatment-emergent adverse events and changes in laboratory tests and vital signs for up to 12 months. These evaluations help researchers understand the effects and safety of the treatments over time.

Researchers are evaluating the effects of subcutaneous injections of pentosan polysulfate sodium PPS compared with placebo in adults experiencing knee osteoarthritis OA pain. This randomized, double-blind, placebo-controlled phase 3 study aims to measure changes in pain and function over a treatment and follow-up period. The study involves participants with knee OA who have not responded to certain existing therapies, and the research is sponsored by Paradigm Biopharmaceuticals Ltd. Participants will be randomly assigned to receive either PPS or a placebo via subcutaneous injections twice weekly for 6 weeks. The study timeline includes a 7-week screening period, a 6-week treatment period, and a 52-week follow-up. Approximately 466 adults will be enrolled, and an interim analysis will occur after half of the participants complete Day 112, with final analyses conducted after all complete Day 404. Throughout the study, participants will visit the study center twice weekly during treatment and approximately every 4 to 6 weeks during follow-up. They will undergo assessments of knee pain using daily pain scores, function evaluations with the WOMAC index, quality of life questionnaires, and imaging tests including MRI and X-rays. Researchers will monitor safety through adverse event tracking and clinical tests. Total participation may last up to 64 weeks.

Researchers are evaluating the long-term safety and tolerability of ianalumab in adolescents and adults with moderate-to-severe systemic lupus erythematosus SLE who have previously completed treatment in one of two core SIRIUS-SLE studies. This Phase 3 extension study compares monthly or quarterly subcutaneous ianalumab to monthly placebo in participants who are positive for anti-nuclear antibodies ANA. The study aims to understand how ianalumab performs over an extended period in this patient group. Participants receive ianalumab either monthly or quarterly via subcutaneous injection, or a monthly placebo injection, throughout the extension study. Only those who completed the initial 60-week treatment period of the core studies without discontinuation are eligible. The study involves random assignment to one of the three groups and follows a quadruple-blind design to ensure unbiased results. During the trial, participants are monitored for treatment-emergent adverse events and serious adverse events up to approximately 91 months. Researchers also assess lupus disease activity, damage progression, corticosteroid use, and flare rates. Safety and tolerability are closely observed through regular evaluations, with the study lasting until April 2032, allowing for comprehensive long-term data collection.