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Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread from the cervix to other parts of the body. This Phase 3 study aims to evaluate the safety and effectiveness of combining sacituzumab tirumotecan (sac-TMT), an antibody drug that targets cancer cells, with pembrolizumab and bevacizumab. The study seeks to find out if this combination can help people live longer or keep their cancer from worsening compared to standard treatments. The study has two parts. In Part 1, participants receive sac-TMT together with pembrolizumab and bevacizumab to assess safety. In Part 2, after standard initial treatment, those whose cancer does not progress will be randomly assigned to maintenance treatment with either pembrolizumab alone or sac-TMT plus pembrolizumab. Bevacizumab may be added during maintenance treatment based on the doctor's decision. All treatments are given through intravenous infusions, and participants may receive rescue medications to manage side effects before sac-TMT infusion. Participants will be monitored for adverse events and treatment tolerability over several months. The study measures include progression-free survival and overall survival, assessed by independent review. Safety and treatment continuation rates are tracked during Part 1 for up to approximately 66-69 months, while Part 2 outcome measures extend up to 48-60 months. Various assessments, including laboratory tests and evaluations of cancer status, will be performed throughout the study to understand treatment effects and participant well-being.

Researchers are studying early detection and risk assessment of hepatocellular carcinoma (HCC) in adults with advanced liver disease, specifically liver cirrhosis of various causes. This prospective multicenter study aims to compare ultrasound and abbreviated MRI (AMRI) as surveillance methods for HCC. The research also investigates how body composition, including fat and muscle mass, relates to imaging features, disease progression, and HCC risk. Participants undergo regular clinical assessments and imaging tests at set intervals to monitor liver lesions and body composition. The study focuses on lesions at high risk for HCC, using both ultrasound and MRI-based LI RADS criteria across multiple visits up to 18 months. Muscle mass is also evaluated at baseline and follow-up visits. The study tracks liver-related clinical events from enrollment for a total of 24 months. Throughout the study, participants receive structured evaluations including imaging, clinical assessments, and muscle scoring. Researchers collect longitudinal data to develop prediction models for HCC risk and liver disease outcomes. The study monitors incident HCC cases, liver complications, and mortality to better understand disease progression and surveillance effectiveness in advanced liver disease.

Unhealthy lifestyle habits are major risk factors for cardiovascular disease (CVD), which is the leading cause of death worldwide and in Sweden. This research evaluates a digital lifestyle program developed within Swedish primary healthcare to see if it can improve important heart health outcomes and encourage healthier habits in adults aged 40 to 60. The study is a multi-center randomized trial comparing standard care alone to standard care plus the digital intervention. The main goal is to measure LDL-cholesterol levels six months after starting the study, along with other health and lifestyle factors. Participants receive standard care consisting of one structured health dialogue focused on lifestyle habits. Those in the intervention group also get access to the digital lifestyle program, which includes digital lectures, home assignments, and group meetings online. Healthcare providers can offer personalized digital support and feedback to help patients improve diet, physical activity, alcohol use, tobacco use, sleep, and stress management. The intervention is delivered entirely through digital means alongside regular primary care. During the study, participants will be monitored for changes in cholesterol levels, blood sugar, blood pressure, weight, body measurements, cardiovascular risk scores, diet, physical activity, sleep, stress, alcohol and tobacco use, and quality of life. These assessments happen six months after randomization to evaluate the effects of the intervention. The study uses these measures to understand how well the digital program supports healthier lifestyle changes and reduces cardiovascular risk.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are studying head and neck squamous cell carcinoma (HNSCC) patients with factors that increase the risk of treatment failure. The goal is to personalize treatment and improve outcomes for those receiving curative radiotherapy. This phase III trial compares the standard radiation dose to a higher dose given more frequently (hyperfractionated radiotherapy) to see if intensifying treatment benefits patients with advanced disease. The study also explores advanced imaging and genetic tests to better predict treatment response and cancer behavior. Participants will be randomly assigned to receive either the standard radiotherapy dose of 68.0 Gy in 34 fractions once daily or a higher hyperfractionated dose of 83.0 Gy in 68 fractions given twice daily over five days a week. Different radiation doses are targeted to the primary tumor and affected lymph nodes based on risk areas. The trial includes translational research using MRI, CT, and PET scans, as well as gene and protein analyses, to understand tumor characteristics and treatment effects. Patients with lower-risk tumors not eligible for randomization can still join the research parts that do not involve altered radiation schedules. During the study, participants will undergo regular monitoring including imaging and clinical assessments every three months for two years, then every six months up to five years to check local tumor control. Researchers will collect data from these visits along with tissue and blood samples for genetic and immune profiling. Safety, treatment adherence, and long-term outcomes will be closely followed to evaluate the impact of the different radiotherapy approaches and the predictive value of the biological tests.

This trial studies children aged 4 to 9.99 years who were recently diagnosed with Type 1 diabetes within the last 3 months. It aims to evaluate the safety and effectiveness of Verapamil in preserving the remaining function of insulin-producing beta cells. The study is a Phase I/II trial motivated by the importance of maintaining residual insulin secretion to improve treatment outcomes and quality of life in young children with this serious disease. The study has two parts: Part A involves 6 patients in an open-label safety evaluation receiving oral Verapamil at doses of 3-6 mg per kg of body weight per day, divided into two doses, for 12 months. After confirming safety and tolerability at 6 months, Part B enrolls 30 patients randomized 1:1 to receive either Verapamil at the same dosing schedule or placebo for 12 months in a double-blind manner. Efficacy is assessed using mixed meal tolerance testing (MMTT) and clinical measures including insulin dose, HbA1c, and continuous glucose monitoring data at baseline, 12 months, and 24 months. Participants undergo baseline screening including ECG, physical exams, and MMTT to assess beta cell function. Outcomes measured include changes in C-peptide levels during MMTT over 24 months and the number of treatment-related adverse events. Clinical monitoring includes HbA1c, insulin use, and glucose control data. Safety and tolerability are closely observed throughout both study parts. The total participation period extends to 24 months with evaluations at multiple time points to track treatment effects and safety.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are investigating whether adding regular radiological scans during follow-up after surgery for high-risk malignant melanoma improves patient survival. This study focuses on patients who have undergone radical surgery for stage IIb-c and III cutaneous malignant melanoma. Since radiological exams can be costly, cause anxiety, and expose patients to radiation, the study aims to determine their value especially given the availability of effective medical treatments for melanoma. Participants are randomly assigned to one of two groups for a 3-year follow-up period. One group receives routine follow-up with regular doctor visits according to national guidelines. The other group receives the same follow-up plus whole body CT or PET scans and blood tests at baseline, 6, 12, 24, and 36 months. An interim analysis will be done after 1000 patients have enrolled. Throughout the study, researchers will monitor overall survival over a 5-year period. Participants will have scheduled assessments including scans and blood tests if assigned to the imaging group. The study also tracks adherence to follow-up visits and any health changes. This approach aims to provide clear evidence on the benefit and impact of imaging during follow-up after melanoma surgery.