Viana Do Castelo

Researchers are evaluating litifilimab BIIB059, a monoclonal antibody, in adults with active cutaneous lupus erythematosus CLE. This includes those with subacute or chronic CLE, with or without systemic lupus erythematosus SLE, who have not responded well or tolerated antimalarial treatments. The study aims to assess how litifilimab affects skin disease activity using scoring tools such as CLA-IGA-R and CLASI, as well as its safety and impact on quality of life. The study has two parts Part A and Part B. After screening, participants are randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks for 24 weeks in a double-blind setup. After this, all participants receive litifilimab for another 28 weeks. Those who finish may join a long-term extension study or enter a safety follow-up lasting up to 24 weeks. Treatment involves regular injections and monitoring during these periods. Participants will undergo assessments of skin symptoms, immune responses, and quality of life using questionnaires. Researchers will measure outcomes like the percentage of participants achieving low skin redness scores and significant reductions in skin disease activity. Safety monitoring continues through the study and follow-up, with total participation lasting up to 80 weeks.

Researchers are evaluating the effectiveness, safety, and tolerability of oral icotrokinra in treating adults and adolescents with moderately to severely active ulcerative colitis UC, a chronic condition where the large intestine lining becomes inflamed and develops ulcers. This Phase 3 clinical trial aims to compare icotrokinra with a placebo to better understand its impact on UC symptoms and remission rates. Participants will be divided into study groups receiving either icotrokinra or a placebo orally each day starting from Week 0 of the induction phase. After 12 weeks, responses will be assessed and participants who respond to icotrokinra or placebo enter a maintenance phase lasting up to Week 40. Adolescents receive open-label icotrokinra throughout the study, with an option for a long-term extension after completing the maintenance phase. During the trial, participants will undergo regular evaluations including clinical response, endoscopic assessments, and symptom monitoring at key points such as Weeks 12 and 40. Researchers will track remission rates, symptom improvements, quality of life, and safety outcomes. The study involves both double-blind and open-label phases and continues until January 2032, with close monitoring to understand how participants respond over time.

Researchers are evaluating filgotinib in children and adolescents aged 8 to less than 18 years with moderately to severely active ulcerative colitis UC. This study aims to assess the medicines efficacy, safety, tolerability, and how the body processes it. About 80 participants will be enrolled, including at least 8 children aged 8 to under 12 years. The study focuses on those who have had insufficient response or intolerance to other treatments like corticosteroids or biologics. Participants will take filgotinib tablets once daily in the morning, with or without food. Doses are designed to achieve similar blood levels as seen in adults treated with 200 mg daily. On-site dosing will occur at Weeks 4, 10, and 22, while other doses are taken at home. Those not showing remission or response by Week 10 will continue induction treatment until Week 22. If remission is not reached by Week 22, participants will stop the study treatment. During the study, researchers will monitor participants health, collecting data on remission rates and response at Week 10 and beyond. Safety and tolerability will be assessed through Week 58 and Week 62. Participants will have regular visits to take medicines, report symptoms, and undergo examinations. The total participation time can last over a year as the study tracks long-term effects and treatment outcomes.

Researchers are evaluating whether baricitinib can delay the onset of clinical type 1 diabetes T1D in children and adults at high risk of developing the disease. This phase 3, double-blind, randomized, placebo-controlled study focuses on participants aged 1 to under 36 years who have early-stage T1D or related autoantibody markers. The goal is to understand if baricitinib can postpone the progression to stage 3 T1D over a study period lasting up to approximately five years. Participants will be randomly assigned to receive either baricitinib or a placebo, both taken orally. The study includes a double-blind design, meaning neither participants nor researchers know who is receiving the active drug or placebo. The research team will monitor participants for up to about five years to assess the time it takes to develop stage 3 T1D and other health measures. Throughout the study, participants will undergo various assessments including measurements of glucose-stimulated C-peptide, glucose levels, body measurements such as height and BMI percentile, and health surveys. Blood samples will be collected to analyze baricitinib levels and its effects on glucose metabolism. The primary outcome is the time from baseline until diagnosis of stage 3 T1D. Safety and health status will be closely observed during the study period.

Researchers are evaluating whether baricitinib can help preserve beta-cell function in children and adults newly diagnosed with type 1 diabetes. This Phase 3 study focuses on participants aged 1 to less than 36 years and aims to understand how baricitinib affects the progression of the disease by comparing it to a placebo. The study is led by Eli Lilly and Company and will last about 60 weeks. Participants are randomly assigned to receive either baricitinib or a placebo, both administered orally. The study is double-blind, meaning neither participants nor researchers know who receives which treatment during the trial. The main treatment period will last up to 52 weeks, during which various health measures related to diabetes control and beta-cell function will be monitored. During the study, participants will undergo regular assessments including measurements of C-peptide levels, hemoglobin A1c, insulin doses, and hypoglycemic events. Researchers will also evaluate physical growth, health survey responses, and pharmacokinetics of baricitinib. Safety monitoring and follow-up visits will continue throughout the approximately 60-week participation period to gather comprehensive data on the impact of the treatment.

Researchers are studying IPN10200 to evaluate its safety and effectiveness in treating adults with upper limb spasticity caused by stroke or traumatic brain injury. This integrated Phase III study aims to understand how different doses of IPN10200 affect patients and to find the doses that balance the best effects with safety. The trial is double-blind, randomized, and includes comparisons with Dysport and placebo treatments to provide thorough evaluation. The study involves several stages, starting with dose escalation where participants receive a single injection of IPN10200, Dysport, or placebo in increasing doses across groups. Later stages test two fixed doses of IPN10200 injected into various upper limb muscles. Participants are randomly assigned to different groups in ratios such as 332 or 21 depending on the stage. Each participant receives a single local injection tailored to their assigned dose group. During the trial, participants will be monitored for up to 9 months to assess safety through adverse events, vital signs, lab tests, and antibody presence. Researchers will also measure treatment effects using the Modified Ashworth Scale to evaluate muscle spasticity changes, patient and physician global assessments, pain reduction, and disability scores. Follow-up includes regular evaluations of muscle tone, treatment response timing, and overall function to understand IPN10200s impact and safety profile.

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This Phase 3 program includes two separate studies with different treatment goals. Study 1 includes both induction and maintenance treatment and aims to see if tulisokibart doses are better than placebo in achieving clinical remission and endoscopic response at 12 and 52 weeks. Study 2 focuses only on induction treatment with similar goals measured at 12 weeks. Participants receive different dosing regimens of tulisokibart administered either intravenously IV or subcutaneously SC. Study 1 has groups receiving high or low dose IV tulisokibart followed by high or low dose SC tulisokibart maintenance, as well as placebo groups matching these routes. Study 2 includes induction treatment with high or low dose IV tulisokibart or placebo. Some participants may continue in extension arms with SC dosing after completing their initial study phase if they meet specific requirements. During the study, participants will be assessed regularly for clinical remission using Crohns Disease Activity Index scores or stool frequency and abdominal pain scores, and for endoscopic response by examination. These assessments occur at weeks 12 and 52 for Study 1 and at week 12 for Study 2. Researchers will monitor safety by tracking adverse events and treatment discontinuations. The total participation duration varies, with Study 1 lasting up to 52 weeks and Study 2 up to 12 weeks.

Researchers are evaluating camizestrant, a new oral drug, compared to standard adjuvant endocrine therapies for patients with early breast cancer that is estrogen receptor positive and HER2 negative. This trial focuses on patients at intermediate-high or high risk for the cancer returning who have completed local treatments like surgery, with or without chemotherapy. The study is a Phase III open-label trial sponsored by AstraZeneca, aiming to see if camizestrant improves invasive breast cancer-free survival over a planned treatment duration of seven years. Participants will be randomly assigned to one of two treatment groups one receiving standard endocrine therapy chosen by the doctor including aromatase inhibitors such as exemestane, letrozole, or anastrozole, or tamoxifen with or without abemaciclib, and the other receiving camizestrant with or without abemaciclib. Treatments are taken orally, and both groups are followed for up to 10 years from the last patients randomization to monitor outcomes and safety. During the study, participants will have regular assessments to monitor invasive breast cancer-free survival, overall survival, and other outcomes like distant relapse-free survival and quality of life. Safety evaluations include tracking side effects using established criteria and patient-reported measures. Pharmacokinetics of camizestrant will be studied for six months, with adverse events monitored up to 28 days after the last treatment dose. The total involvement can last up to 14 years including treatment and follow-up periods.

This research aims to evaluate the safety and effectiveness of the Hydrustent4 biodegradable hydrogel ureteral stent in adults with urinary lithiasis who have undergone surgery to remove ureteral or renal stones. The study will compare Hydrustent4 to a standard ureteral stent device to determine if it is at least as safe and effective in maintaining urine flow through the ureter after surgery. The trial includes both a pilot phase to explore initial safety and efficacy and a pivotal phase to confirm clinical performance. Participants will receive either the Hydrustent4 stent or a comparator ureteral stent after stone removal surgery. The Hydrustent4 device is designed to degrade naturally in the body, potentially avoiding the need for a second surgery to remove the stent, while the comparator is a conventional polyurethane double loop stent. The study will monitor the durability of the device for at least 24 hours and assess whether the device reduces urinary symptoms and prevents additional surgical procedures. During the 3-month follow-up period, participants will attend regular visits for assessments including questionnaires, imaging exams, and blood and urine tests to monitor recovery and device performance. Researchers will closely track safety through adverse events and device issues, evaluate urine drainage after stent placement, and assess symptoms related to the stents. The study will measure both technical success and tolerability of the devices throughout the treatment and follow-up phases.

Crohns disease is a long-term condition causing severe inflammation in the digestive tract, mainly the bowels. It leads to symptoms like belly pain, diarrhea, tiredness, and weight loss. Treatments exist but may not work the same for everyone or may lose effectiveness over time. This study is evaluating the effectiveness and side effects of several targeted therapies TaTs in adults with moderate to severe Crohns disease. About 540 adults will participate at around 300 sites worldwide to better understand these treatments. Participants will be randomly assigned to different treatment groups receiving various combinations or single therapies. These include Risankizumab, Trosunilimab, Lutikizumab, and ABBV-8736, delivered either by subcutaneous injection or intravenous infusion. Some groups receive monotherapy while others receive combination therapies. Treatment can last up to 72 weeks, with specific dosing schedules for each drug. The study includes a long-term extension phase for Risankizumab monotherapy. Throughout the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, endoscopies, and monitoring for side effects. They will also complete questionnaires and keep a daily diary to track symptoms. The main outcomes measured include the percentage of participants achieving endoscopic remission at 12 weeks and the number experiencing adverse events over about 96 weeks. Secondary measures focus on clinical remission and response. This careful monitoring helps researchers understand how well the therapies work and their safety profiles.