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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 evaluating the effectiveness and safety of icotrokinra in adults with moderately to severely active Crohn's disease, a chronic condition causing severe inflammation in the intestinal tract. This Phase 2b/3 study aims to understand how well icotrokinra works compared to a placebo in improving symptoms and intestinal healing in this patient group. Participants will receive either icotrokinra or a matching placebo orally every day. The study includes both induction and maintenance phases where researchers assess clinical and endoscopic responses at specific time points, such as Week 12 and Week 40, to determine treatment effects over time. Throughout the study, participants will undergo various assessments including clinical evaluations, endoscopic exams, and safety monitoring. Researchers will measure outcomes like clinical response, clinical remission, and endoscopic healing at Weeks 12 and 40. The study involves regular monitoring to track the participants' health and treatment adherence over the duration of the trial.

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

Migraine is a condition that often causes moderate to severe headaches on one side of the head, sometimes with throbbing pain, nausea, vomiting, and sensitivity to light and sound. This study evaluates the safety and effectiveness of atogepant, a medicine approved for preventing migraines in adults, to see how well it works compared to placebo in preventing chronic migraines in participants aged 12 to 17 years. The study is a phase 3, double-blind trial where neither the participants nor the doctors know who receives the medicine or placebo. Participants will be randomly assigned to receive either oral atogepant tablets or placebo tablets once daily for 12 weeks. Following the treatment period, there will be a 4-week follow-up phase. The study involves about 420 participants at approximately 70 sites worldwide. Throughout the study, participants will visit hospitals or clinics regularly to complete daily diaries, undergo medical assessments and blood tests, report any side effects, and complete questionnaires. Researchers will measure the number of participants experiencing adverse events and track changes in the average monthly number of migraine days from the start of the study through week 12.

Researchers are evaluating the effects of tirzepatide compared with standard care in adults living with obesity who do not have diabetes. This phase 4 study aims to assess weight loss and the occurrence of type 2 diabetes over a long period in a real-world setting. Participants must have obesity and at least one weight-related health condition to join the study. Participants will receive either tirzepatide, given once weekly by injection under the skin, or continue with standard care as determined by their healthcare providers. The study is designed to reflect real-life treatment and monitoring situations to understand how tirzepatide works outside of tightly controlled clinical trials. The study lasts about 260 weeks, during which participants will be regularly monitored for changes in body weight and the development of type 2 diabetes. Measurements will be taken at the start and throughout the study to track weight changes. Researchers will also observe safety and overall health during this extended follow-up period.

Researchers are evaluating the safety and effectiveness of low-dose and high-dose atogepant in children and adolescents aged 6 to 17 who experience episodic migraine. Migraines are moderate to severe headaches often accompanied by symptoms such as throbbing pain, nausea, and sensitivity to light and sound. While several treatments exist for adults, options for younger patients are limited, making this Phase 3 study important to understand how atogepant works in this younger population. Participants aged 6 to 17 will be randomly assigned to one of six groups to receive either placebo, low-dose atogepant, or high-dose atogepant tablets taken once daily by mouth for 12 weeks. The exact doses for children aged 6 to 11 will be decided after a pharmacokinetic substudy. After 12 weeks, participants may either have a follow-up visit 4 weeks after stopping the treatment or join an extension study to continue taking atogepant for an additional 52 weeks. During the study, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and to monitor for any side effects. They will also complete questionnaires to evaluate how treatment affects their migraines. The main outcomes measured are changes in the number of monthly migraine days over 12 weeks and the number of participants experiencing adverse events during the first 16 weeks. About 450 participants will be enrolled across roughly 100 sites worldwide.

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 effectiveness and safety of induction therapy with Afimkibart (RO7790121) compared to a placebo in people with moderately to severely active ulcerative colitis (UC). This Phase III, multicenter, double-blind, placebo-controlled study focuses on participants aged 16 to 80 who have an established diagnosis of UC and have shown inadequate response or intolerance to previous UC treatments. Participants will receive either Afimkibart or a matching placebo. Those assigned to the Afimkibart group will get the drug first through an intravenous (IV) infusion, followed by subcutaneous (under the skin) injections. The placebo group will receive matching IV and subcutaneous treatments that do not contain the active drug. During the study, participants will be monitored for clinical remission at 12 weeks, which is the primary outcome measure. Researchers will assess safety and response through scheduled visits and evaluations. The study includes careful tracking of participants' health status and any side effects to understand the treatment's impact over the course of the trial.

Researchers are evaluating the prevention of venous thromboembolism (VTE), which can be a serious complication after an acute stroke. This study is focused on immobile stroke patients who cannot walk without help and aims to compare two methods to prevent VTE during a 90-day follow-up period. The study compares the current standard treatment, Intermittent Pneumatic Compression (IPC), with a medical device called the geko17; device, which uses neuromuscular electrical stimulation to improve blood flow and potentially reduce VTE risk. Participants will be randomly assigned to receive either the IPC treatment, which involves air-filled cuffs squeezing the lower legs, or the geko17; device stimulating the peroneal nerve. Both treatments will be applied until the patient can walk independently or for up to 30 days. Leg compression Doppler scans will be done at 7 days (optional) and 14 days (mandatory) after randomisation. At 14 days, patients will also complete a questionnaire about device comfort and provide health information. Additional data on symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) will be collected from medical records at 30 days. During the study, participants will be monitored through scans, questionnaires, and medical record reviews to track any occurrences of DVT or PE. A final follow-up call at 90 days will assess the patient's recovery, health status, mobility, and quality of life. The main outcome measured is the frequency of symptomatic or asymptomatic DVT in the leg veins or any PE from randomisation up to 30 days. This comprehensive monitoring aims to provide clear information about which prevention method may better support immobile stroke patients.

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.