Viseu

Researchers are evaluating the efficacy and safety of Afimkibart also called RO7790121 as both induction and maintenance therapy for people with moderately to severely active Crohns disease. This Phase III, multicenter, double-blind, placebo-controlled study aims to compare Afimkibart treatment with placebo in participants who have shown inadequate response or intolerance to other Crohns disease therapies. Participants will be randomly assigned to receive either Afimkibart or placebo. Those on Afimkibart will get an intravenous IV infusion followed by subcutaneous SC injections, while the placebo group receives matching IV and SC placebo treatments. The study involves treatment through induction and maintenance phases, continuing up to 52 weeks. During the study, participants will undergo evaluations of their Crohns disease activity using clinical remission and endoscopic response measures at weeks 12 and 52. Researchers will also monitor symptoms such as stool frequency, abdominal pain, fatigue, and bowel urgency, along with quality of life assessments. Safety will be tracked for up to 70 weeks after baseline, including monitoring adverse events and presence of fistulas. The total duration of participation may extend through this period for comprehensive assessment.

Researchers are evaluating the efficacy and safety of induction therapy with Afimkibart RO7790121 compared to placebo in people with moderately to severely active ulcerative colitis UC. This Phase III, multicenter, double-blind, placebo-controlled study aims to understand how well Afimkibart works and its safety profile in this population. Participants will be randomly assigned to receive either Afimkibart or a placebo. Those in the Afimkibart group will receive the drug first through an intravenous IV infusion followed by a subcutaneous SC injection. The placebo group will receive matching placebo treatments by IV and SC as well. The study treatment period includes these induction therapies, with monitoring continuing up to 30 weeks for safety. During the study, participants will be assessed for clinical remission at 12 weeks, which is the primary outcome. Other evaluations include changes in partial Modified Mayo Score, endoscopic improvement and remission, histologic improvements, bowel urgency, abdominal pain, fatigue, and health-related quality of life. Safety will be monitored by recording adverse events throughout the study. Participants will have visits for these assessments and monitoring over the course of the study duration.

Researchers are evaluating the effectiveness and safety of induction therapy using Afimkibart RO7790121 in people with moderately to severely active Crohns disease. This Phase III, multicenter, double-blind, placebo-controlled trial aims to understand how well this treatment works compared to placebo during the induction phase. The study focuses on participants who have not responded adequately to other conventional or advanced therapies for Crohns disease. Participants will be randomly assigned to receive either Afimkibart through an intravenous IV infusion followed by subcutaneous SC injections or a placebo IV infusion followed by Afimkibart SC injections. This treatment schedule is designed to assess the induction effectiveness of Afimkibart in reducing disease activity over a 12-week period. The study includes two treatment groups to compare outcomes between the active drug and placebo. During the study, participants will be monitored for clinical remission and endoscopic response at week 12, along with other measures such as symptomatic remission, bowel urgency, abdominal pain, stool consistency, fatigue, and quality of life questionnaires. Safety assessments will continue for up to 30 weeks after baseline to record any adverse events. Participants will attend scheduled visits for evaluations and laboratory tests to track progress and response to treatment throughout the trial.

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 nucresiran in patients with transthyretin amyloidosis who have cardiomyopathy. The study aims to compare the effects of nucresiran versus a placebo on reducing death from any cause and cardiovascular events, as well as assessing patient-reported health status and quality of life. This is a Phase 3, global, randomized, double-blind study sponsored by Alnylam Pharmaceuticals. Participants receive either nucresiran 300 mg or a placebo injected under the skin every six months during the double-blind period. After this, all participants enter an open-label extension where they receive nucresiran 300 mg every six months. The study treatments are given subcutaneously and the double-blind phase is estimated to last about 32 months, with a possible maximum of 5 years. During the study, participants will be monitored for all-cause mortality and cardiovascular events such as hospitalizations and urgent heart failure visits. Quality of life and health status will be assessed using the Kansas City Cardiomyopathy Questionnaire. Regular evaluations include tracking recurrent cardiovascular events and changes in heart failure symptoms. Safety and health will be followed throughout the double-blind and extension periods, with a maximum participation length of about 5 years.