Danderyd

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

This research aims to compare the effects of oral anticoagulation versus no anticoagulation in patients aged 55 and older who have had recent episodes of transient atrial fibrillation triggered by stress and have additional factors that increase their risk of stroke. The study is a multinational, investigator-initiated, prospective, randomized, open-label trial evaluating the impact of non-vitamin K oral anticoagulants NOACs on preventing stroke and other serious cardiovascular events. Participants will be randomly assigned to either receive one of several NOACs, such as edoxaban, apixaban, dabigatran, or rivaroxaban, prescribed by their physician for the duration of the follow-up, or to a control group that will not receive anticoagulants unless medically indicated during the study. The choice of specific NOAC and dose adjustments are determined by the prescribing doctor. The study excludes patients with certain conditions like chronic atrial fibrillation, severe kidney or liver disease, recent cardiac surgery, or bleeding risks. During the study, participants will be monitored for up to 24 months to assess the occurrence of non-hemorrhagic stroke, systemic embolism, vascular mortality, myocardial infarction, peripheral arterial thrombosis, amputation, and venous thromboembolism. Regular follow-up will include evaluation of these outcomes to measure the effectiveness and safety of anticoagulation compared to no anticoagulation. Participants will provide informed consent and remain under medical supervision throughout the trial.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are studying the effects of orticumab treatment on inflammation in people who have had a heart attack and show increased coronary inflammation as seen on coronary computed tomography angiography CCTA. This Phase 2 trial aims to compare the impact of orticumab versus placebo on inflammation in coronary arteries, measured using the Fat Attenuation Index FAI, over a 6-month period. The study focuses on participants with prior myocardial infarction who meet specific inflammation criteria based on CCTA imaging and are on stable cardiovascular treatment. Participants will receive either orticumab or placebo treatment for 24 weeks. There are multiple treatment groups, including high and low doses of both orticumab and placebo. An optional Day 14 sub-study is available where participants can have additional safety assessments and blood tests to measure serum orticumab levels and inflammation biomarkers. Throughout the study, participants are expected to attend all scheduled visits, provide complete medical history, and consult the study doctor before any changes to their usual treatments. During the study, participants will undergo assessments including CCTA scans to measure coronary artery inflammation, blood tests for safety and biomarker analysis, and monitoring for adverse events. The main outcome is the percent change in the mean FAI score in the coronary arteries after 24 weeks of treatment. Secondary outcomes include changes in coronary artery inflammation and CaRi-Heart score. Safety monitoring and adherence to cardiovascular medication regimens will be maintained throughout the trial, which is expected to continue until June 2027.

Researchers are evaluating a new contactless and non-invasive method to measure how the skins tiny blood vessels and their regulatory functions work in both healthy people and those with type 1 diabetes-related microvascular disease. The goal is to find an early way to detect diabetic complications before severe small vessel damage develops. This observational study uses advanced imaging to better understand microangiopathy linked to diabetes. The study uses an investigational device called the TCI P4, which shines patterned light on the skin and captures detailed images to analyze skin structure and molecular makeup, including oxygen and blood content. Measurements from this device will be compared to other established tools like laser speckle contrast imaging and the EPOS system to validate its accuracy. Participants include groups categorized by different severity levels of microvascular complications related to diabetes, as well as healthy controls. Participants will undergo evaluations that measure blood flow responses in the skin, specifically peak perfusion after warming the area and blood flow patterns in the soles of the feet. These assessments happen within one day of enrollment. The study will monitor these microvascular functions to understand their relationship with diabetic damage. Participation involves a single-day visit for these imaging tests. The study is sponsored by Karolinska Institutet and plans to continue until December 2027.

Researchers are evaluating whether a medicine called BI 764198 helps adults and adolescents with certain kidney conditions, including secondary focal segmental glomerulosclerosis, treatment-resistant primary minimal change disease, Alport Syndrome, and treatment-resistant primary membranous nephropathy. The study is a Phase II, randomized, double-blind, placebo-controlled trial designed to assess the safety, tolerability, pharmacokinetics, and efficacy of BI 764198 in these proteinuric kidney diseases. Participants are randomly assigned to one of two groups, with twice the chance of receiving BI 764198 compared to placebo. They take one tablet daily for 20 weeks while continuing their standard kidney disease medications. The study lasts about seven months, during which participants attend six in-person visits and have three phone calls. The trial includes multiple cohorts based on specific kidney conditions. During the study, doctors regularly collect urine samples to measure protein levels and blood samples to monitor kidney function. Researchers compare these results between the treatment and placebo groups to evaluate changes in proteinuria and kidney filtration rate. Participants health and any side effects are closely monitored throughout the trial.

Researchers are evaluating the effects of a restrictive approach to giving non-resuscitation fluids compared to usual care in adult patients with septic shock. The goal is to understand both the beneficial and harmful impacts of limiting these fluids in this critical condition. This trial is led by Region Skane and involves adult patients diagnosed with septic shock under specific clinical criteria. Participants are assigned randomly to one of two groups. One group receives non-resuscitation fluids following a strict protocol that starts within two hours of randomization and continues during their ICU stay, up to 90 days. This protocol includes stopping maintenance fluids if fluid balance is positive and the patient is not dehydrated, adjusting intravenous and enteral fluids to correct electrolyte disturbances, and using concentrated intravenous medications. The other group receives fluids according to usual local care routines, which involve maintenance fluids at about 1 mlkgh unless otherwise specified and glucose at a maximum concentration of 10%, with medications concentrated per local protocol. Participants are monitored during their ICU stay and followed for up to 90 days to assess mortality, complications, and days free from mechanical ventilation. Cognitive function and health-related quality of life are evaluated six months after inclusion. The study uses a triple-blind randomized design to compare outcomes between the protocolized fluid reduction and usual care. Regular assessments and follow-up visits will track participant status and safety throughout the study period.

Researchers are conducting a phase III trial to evaluate the safety and effectiveness of autologous skeletal muscle-derived cells for patients with urge fecal incontinence caused by dysfunction or damage to the external anal sphincter. This study aims to assess clinical outcomes in patients who have not sufficiently improved with conservative treatments. The condition involves uncontrolled leakage due to sphincter weakness or disruption. Participants receive either injections of their own skeletal muscle-derived cells into the external anal sphincter or a placebo solution. The study is randomized with two groups one receiving the investigational cell therapy and the other receiving the placebo vehicle. Both treatments are administered under medical supervision, and the study follows participants over a 12-month period to assess changes in incontinence episodes. During the trial, participants will be monitored for safety and efficacy through regular evaluations. The main outcome measured is the change in the frequency of incontinence episodes over 12 months. The study includes thorough assessments such as anal manometry and ultrasound imaging of the anal canal. Participants adherence, symptoms, and safety are carefully tracked through scheduled visits throughout the trial duration.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.