Viana Do Castelo

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

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 effects of filgotinib in children and adolescents aged 8 to less than 18 years with moderately to severely active ulcerative colitis (UC). The study aims to assess the drug's efficacy, safety, tolerability, and how the body processes the medication. About 80 participants, including at least 8 children aged 8 to under 12, will take part in this Phase 3 trial. Participants will receive filgotinib orally once daily in the morning, with or without food. The study drug is provided as film-coated tablets in doses appropriate for pediatric use, aiming for the same exposure level as adults receiving 200 mg daily. Participants will take the study drug at home on most days, but will take it under supervision at the study site during visits at Weeks 4, 10, and 22. Those not achieving remission or response by Week 10 will continue treatment until Week 22, after which those who still do not reach remission will stop treatment. During the study, participants will be closely monitored for treatment effects and safety. Researchers will assess remission and response at Weeks 10 and 58. Evaluations include clinical scoring of disease activity and safety assessments throughout the trial. Total participation duration and detailed monitoring plans are designed to understand both the short- and longer-term effects of filgotinib in this young population.

Researchers are evaluating whether baricitinib can delay the onset of clinical stage 3 type 1 diabetes (T1D) in children and adults at high risk of developing the disease. This phase 3, double-blind, randomized, placebo-controlled study includes participants aged 1 to under 36 years who have early stages of T1D or multiple diabetes-related autoantibodies indicating increased risk. The study aims to measure the time from the start of the trial to diagnosis of stage 3 type 1 diabetes, with participation lasting up to approximately 5 years. Participants will be randomly assigned to receive either baricitinib or a placebo, both administered orally. The trial compares these two groups to assess the impact of baricitinib on delaying progression to stage 3 T1D. The study's design includes careful monitoring of participants over time to evaluate the effects of the medication or placebo on disease development. During the study, participants will undergo regular assessments to detect the progression of diabetes, including laboratory tests for autoantibodies and clinical evaluations. Researchers will track the time it takes for participants to develop stage 3 T1D, along with monitoring safety and any adverse effects. The total duration of participation can be up to 5 years, ensuring thorough observation of long-term outcomes related to the study interventions.

Researchers are studying whether baricitinib can help preserve beta-cell function in children and adults newly diagnosed with type 1 diabetes. This Phase 3 trial focuses on participants aged 1 to less than 36 years who have recently been diagnosed with this condition. The goal is to understand if baricitinib, compared to a placebo, can maintain insulin-producing cell activity. Participants will be randomly assigned to receive either baricitinib or a placebo, both given orally. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. Treatment and observation will continue for about 60 weeks. During the study, participants will undergo evaluations including measuring C-peptide levels to assess beta-cell function at the start and after 52 weeks. Researchers will monitor health status, collect laboratory tests, and track any side effects or changes in diabetes-related markers to determine the effects of baricitinib over the study period.

Researchers are evaluating the safety and effectiveness of increasing doses of IPN10200 to understand its pharmacodynamics and identify the best dose for treating adults with upper limb spasticity. This integrated Phase I/II, multicenter, double-blind, randomized study also compares IPN10200 with Dysport and placebo to find the optimal balance of efficacy and safety in adults aged 18 to 70 years with spastic hemiparesis following stroke or traumatic brain injury. Participants receive either IPN10200, Dysport, or placebo as a powder and solvent solution for injection. The study includes dose escalation and dose-finding phases to assess different dosing levels. Treatments are administered in the affected upper limb muscles, with eligibility based on specific muscle tone and spasticity angle criteria. The study monitors participants for up to 9 months, including a safety follow-up period. During the study, participants undergo regular assessments including vital signs (blood pressure and heart rate), clinical lab tests, physical examinations, and monitoring for treatment-emergent adverse events and antibodies to the study drugs. Researchers use these measures to evaluate safety and treatment effects over the 9-month period from baseline through the end of the study.

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).

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating the safety and effectiveness of the Hydrustent4 biodegradable hydrogel ureteral stent in adults with urinary lithiasis (kidney or ureteral stones). This study compares Hydrustent4 to a standard polyurethane double loop ureteral stent to see if it can maintain urinary flow after surgery without causing additional medical problems. The study includes both an initial pilot phase to assess safety in 16 participants and a larger pivotal phase with 118 participants to confirm clinical performance and safety. Participants will receive either the Hydrustent4 biodegradable stent, which naturally degrades in the body and avoids the need for removal surgery, or the standard polyurethane stent known for good tolerance and resistance to encrustation. These devices are inserted after stone removal surgery using endourological techniques. The study involves two phases: the pilot phase focuses on initial safety and some efficacy results, while the pivotal phase gathers comprehensive data on safety and effectiveness. During the 3-month follow-up period, participants will attend regular visits for monitoring recovery. Researchers will collect data through questionnaires, imaging exams, blood and urine tests, and will track urinary drainage and adverse events from surgery up to day 28 post-treatment. The study aims to measure if Hydrustent4 maintains urine flow, prevents the need for additional surgery to remove the stent, reduces urinary symptoms, and is durable for at least 24 hours. Safety is closely monitored throughout the treatment period.

Researchers are evaluating targeted therapies for adult participants with moderate to severe Crohn's disease, a chronic condition causing severe inflammation in the digestive tract. This disease often leads to symptoms like belly pain, diarrhea, tiredness, and weight loss. The study aims to assess the effectiveness and side effects of several targeted treatments, as current therapies may not work equally well for all patients or may lose effectiveness over time. This is a Phase 2a multicenter, randomized platform study enrolling around 540 adults across approximately 300 sites worldwide. The treatments being studied include risankizumab, trosunilimab, lutikizumab, and ABBV-8736. These therapies are administered either as injections under the skin or infusions into the vein, depending on the drug. Participants will be randomly assigned to one of the treatment groups. The study will involve regular visits to hospitals or clinics where participants receive their assigned treatments and are monitored throughout the study period. Participants will undergo medical assessments including blood tests and endoscopies to check the status of their disease and to monitor for any side effects. They will also complete questionnaires and keep a daily diary to track their condition. The main outcome measured is the percentage of participants who achieve endoscopic remission by week 12. The study involves careful safety monitoring and aims to provide detailed data on the treatments over the course of the trial.