Danderyd

This trial investigates the safety and effectiveness of risankizumab compared to vedolizumab in adults with moderate to severe ulcerative colitis (UC) who have not previously received targeted therapies. Ulcerative colitis is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. The study is a Phase 3b, randomized, open-label trial enrolling about 530 participants across 285 sites worldwide. Participants will be randomly assigned to receive either risankizumab or vedolizumab. Those in the risankizumab group will receive the drug intravenously during the initial induction phase, followed by subcutaneous injections for maintenance. Participants in the vedolizumab group will receive the drug intravenously throughout the study. The treatment period lasts 44 weeks for risankizumab and 46 weeks for vedolizumab, following a screening period of up to 35 days. During the study, participants will attend regular outpatient visits for medical assessments, side effect evaluations, and to complete questionnaires. Researchers will monitor disease activity and drug safety, focusing on the percentage of participants achieving endoscopic improvement by week 48. The total study duration is approximately 69 weeks for risankizumab and 71 weeks for vedolizumab recipients.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are evaluating the effects of a medicine called BI 764198 in adults and adolescents aged 12 years and older who have a kidney condition known as focal segmental glomerulosclerosis (FSGS). This Phase 3 study aims to understand whether BI 764198 can improve kidney health in people with primary FSGS or genetic FSGS related to TRPC6 gene variants by comparing changes in urine protein levels over 104 weeks. Participants are randomly assigned to one of two groups: one group takes BI 764198 tablets once daily, and the other group takes placebo tablets that look like the medicine but contain no active drug. All participants continue their usual FSGS treatments during the study, which lasts up to two years. During the study, participants visit the study site approximately every three months. They regularly provide urine samples to monitor kidney function, and doctors check their overall health and note any side effects. The main outcome measured is the change in the 24-hour urine protein-to-creatinine ratio from the start of the study to week 104, helping researchers understand the treatment's impact on kidney disease.

Researchers are evaluating the use of non-vitamin K oral anticoagulants (NOACs) compared to no anticoagulation in people who have experienced transient atrial fibrillation episodes triggered by stress and have additional risk factors for stroke. This multinational, investigator-initiated Phase 4 trial aims to prevent stroke and other serious cardiovascular events in this group by assessing the effects of NOACs on two main outcomes: the occurrence of non-hemorrhagic stroke or systemic embolism, and a combination of vascular death and other major cardiovascular problems, over a follow-up period lasting until the last participant reaches 24 months of observation. Participants in the study are randomly assigned to either receive one of several NOAC medications—edoxaban, apixaban, dabigatran, or rivaroxaban—with dosing adjusted as needed and chosen by their prescribing doctor, or to receive no oral anticoagulation. The treatment continues throughout the follow-up period. The trial is open-label, meaning both researchers and participants know which treatment is given. The study specifically focuses on patients who had transient atrial fibrillation related to stress, such as after certain surgeries or acute medical illness. During the study, participants undergo regular monitoring to track the incidence of stroke, embolism, vascular death, heart attacks, blood clots, and other cardiovascular events. Researchers collect information over up to two years to evaluate these outcomes. Safety and adherence to treatment are also monitored. This thorough follow-up helps determine the impact of NOAC treatment compared to no anticoagulation in this particular patient population.

Researchers are evaluating the effects of orticumab treatment on coronary artery inflammation in people who have had a myocardial infarction (heart attack) and show elevated coronary inflammation based on CT coronary angiography (CCTA). This Phase 2, multicenter, double-blind, randomized study compares orticumab to a placebo to understand its impact on inflammation in coronary arteries, focusing on participants with prior heart attacks and elevated Fat Attenuation Index (FAI) scores. Participants will receive either orticumab or placebo treatments for 24 weeks. An optional Day 14 sub-study includes safety assessments and blood tests to measure orticumab levels, antibodies against the drug, and biomarkers related to heart and inflammation health. The study monitors coronary inflammation via CCTA scans, focusing on the Fat Attenuation Index of three coronary arteries. During the study, participants will attend scheduled visits, provide medical history, and communicate with study doctors before making any changes to their treatments or joining other studies. Researchers will measure changes in coronary artery inflammation using the FAI score at 24 weeks. Safety is monitored through adverse event tracking and laboratory tests. The study aims to assess both the clinical effects and safety of orticumab over six months of treatment.

Researchers are evaluating a new contactless and non-invasive method to measure the skin's microcirculation and its regulatory functions in both healthy people and those with microvascular disease linked to type 1 diabetes. The goal is to develop a tool that can detect diabetic complications early, allowing treatment before severe microangiopathy develops. This study focuses on understanding how microvascular function correlates with the degree of microangiopathy in individuals with type 1 diabetes compared to healthy controls. The study uses an investigational device called TCI P4, a novel Spatial Frequency Domain Imaging (SFDI) system that projects patterned, multi-wavelength LED light onto the skin and captures reflections with multiple cameras. This produces detailed two-dimensional images showing skin structure and molecular makeup, including hemoglobin, oxygen, and water content. To validate the new device's accuracy, established methods like laser speckle contrast imaging (LSCI) and the EPOS system are also used as comparators. Participants will undergo evaluation of peak blood flow response in the skin within one day of enrollment to assess microvascular function. The study collects data from these imaging techniques and compares them across study groups. Researchers will monitor skin responses and microcirculation characteristics to better understand microangiopathy in diabetes. The total participation time for each individual is limited to this brief evaluation period, focusing on detailed skin perfusion measurements.

Researchers are evaluating whether the medicine BI 764198 can help adults and adolescents with specific kidney diseases, including secondary focal segmental glomerulosclerosis, treatment-resistant primary minimal change disease, Alport Syndrome, and treatment-resistant primary membranous nephropathy. This Phase II study aims to assess the safety, tolerability, and effectiveness of BI 764198 compared to a placebo in these proteinuric kidney diseases. Participants are randomly assigned to one of two groups: one group takes BI 764198 tablets once daily, while the other takes placebo tablets that look like the medicine but contain no active drug. All participants continue their usual kidney disease treatments during the 20-week treatment period. After treatment, there is a follow-up period, and overall, participants are involved in the study for about seven months. During the study, participants visit the study site six times and have three phone calls with the study team. Doctors regularly collect urine and blood samples to monitor protein levels and kidney function. Researchers compare these results between the two groups to determine if BI 764198 affects kidney disease markers. Participants' health and any side effects are also closely monitored throughout the study.

This trial evaluates the effects of a restrictive approach to giving non-resuscitation fluids in adults with septic shock, a serious condition caused by infection leading to dangerously low blood pressure. The study aims to assess both the potential benefits and harms of limiting these fluids compared to usual care. The trial focuses on adult patients diagnosed within 12 hours of intensive care unit (ICU) admission who require medication to support blood pressure. Participants are randomly assigned to one of two groups. The first group follows a protocol to reduce non-resuscitation fluids, where maintenance fluids are stopped if the patient has a positive fluid balance and is not dehydrated. Fluids and nutrition are carefully managed according to specific guidelines, including concentrated intravenous medications and nutrition support if needed. The second group receives usual care with fluids and medications given according to local routines, including maintenance fluids at a set dose unless otherwise specified. During the study, researchers monitor participants closely, focusing on mortality within 90 days after enrollment as the primary outcome. Fluid balance, medication use, nutrition, and patient condition are assessed to compare the two approaches. The study includes adult patients admitted to the ICU with septic shock and requires monitoring during their stay and follow-up to understand the effects of fluid management strategies on survival and safety.

The trial investigates the safety and effectiveness of using autologous skeletal muscle-derived cells to treat urge fecal incontinence caused by dysfunction or damage to the external anal sphincter. It focuses on patients whose condition has not improved adequately with at least three months of conservative treatment and who experience frequent urge fecal incontinence episodes. This is a Phase III, randomized, controlled, double-blind study designed to assess this treatment. Participants receive either autologous muscle-derived cells injected into the external anal sphincter or a placebo solution as a control. The study compares these two groups to evaluate the impact of the cell implantation on fecal incontinence symptoms. The treatment aims to address sphincter weakness or disruption that contributes to the incontinence. During the study, participants are monitored for changes in the frequency of incontinence episodes over 12 months. Assessments include anal manometry and ultrasound imaging to evaluate sphincter function and injury extent. Safety and efficacy are carefully tracked throughout the study period to determine the treatment’s clinical effects and tolerability.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.