Jackson

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

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.

Ovarian cancer is a serious health concern with the highest death rate among gynecological cancers. Diagnosing ovarian cancer definitively requires surgery since current tests cannot reliably distinguish between benign and malignant ovarian abnormalities before surgery. Researchers are evaluating the Cleo Diagnostics CleoDX Ovarian Adnexal Mass Score Test System, which measures five blood biomarkers to better assess the likelihood of cancer in patients with ovarian masses needing surgery. This test aims to help doctors make more informed decisions about surgery and patient care by providing a more accurate pre-surgical cancer risk assessment. The study involves patients with ovarian cysts or adnexal masses identified by imaging who require surgery but have not yet undergone it. The CleoDX test analyzes blood samples to generate a score indicating cancer risk, and patients are categorized after surgery as having malignant or benign masses. The study compares the CleoDX test results to standard clinical assessments and post-surgical pathology to evaluate the tests accuracy and performance. Participants will provide blood samples before surgery, and their clinical and pathological information will be collected and analyzed. The primary outcome is the calculation of the CleoDX adnexal mass score, with secondary outcomes comparing the tests score to clinical and pathological findings. Data analysis will take place after patient recruitment, continuing for up to 12 months or until the study ends in August 2026. The study involves monitoring and evaluating the tests ability to predict cancer risk accurately before surgery.

Researchers are evaluating the effectiveness of pegloticase administered by two different methodssubcutaneous under the skin injection versus intravenous into a vein infusioneach combined with methotrexate MTX in participants who have uncontrolled gout. The main goal is to compare how well these two treatment methods maintain normal serum uric acid levels over a six-month period. This Phase 3 trial is designed as a double-blind, randomized controlled study to provide reliable information on treatment responses.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months 4 years, followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry DXA. Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

Researchers are evaluating the safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating nipocalimab compared to a placebo in adults with moderate to severe systemic lupus erythematosus SLE, a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This Phase 3 study aims to understand how well nipocalimab works in treating SLE symptoms and disease activity. Participants will receive either nipocalimab or a placebo alongside standard care treatments during a double-blind treatment period lasting up to 52 weeks. After this period, eligible participants from both groups may enter an open-label long-term extension phase to continue nipocalimab treatment until Week 156 or until discontinuation. Throughout the study, participants will undergo assessments including measurement of disease activity, joint pain, fatigue, and flare status. Researchers will monitor responses such as the SLE Responder Index at Week 52, and track safety and treatment adherence. The total participation duration may extend up to approximately three years including the extension phase.

Researchers are evaluating the safety and performance of the Indigo Aspiration System in patients with lower extremity acute limb ischemia LE ALI, a condition involving sudden blockage of blood flow in the lower limbs. The study aims to collect clinical evidence to support the use of this device in removing blood clots causing the ischemia. This observational study focuses on patients diagnosed with LE ALI and assesses the devices impact on limb salvage and other clinical outcomes. Participants will undergo treatment using the Indigo Aspiration System, which involves mechanical aspiration thrombectomy to remove the thrombus. The study includes patients with confirmed arterial occlusion in the lower limb, using the device as the first-line treatment. The intervention is delivered with computer-assisted vacuum thrombectomy aspiration tubing during the procedure. During the study, participants will be monitored for outcomes such as target limb salvage rate at 30 days post-procedure, technical success immediately after the procedure, and primary vessel patency at 30 days. Researchers will also track device-related adverse events including bleeding, distal embolization, serious adverse events, and mortality up to 180 days post-procedure. Participants will be involved in follow-up assessments to evaluate these outcomes and safety measures over time.

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.