Malbork

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Hidradenitis Suppurativa HS is a skin condition that causes painful bumps, abscesses, scars, and tunnels in areas where the skin rubs together. This condition may start when hair follicles become damaged, triggering the immune system and allowing bacteria to worsen the symptoms. Researchers are evaluating the safety, effectiveness, and tolerance of a drug called zasocitinib in adults with moderate to severe HS compared with a placebo in this Phase 2 clinical trial. Participants will be randomly assigned to receive either zasocitinib or a placebo for the first 16 weeks in a double-blind period. After this, all participants will receive zasocitinib for an additional 36 weeks in an open-label period. The placebo capsules look like zasocitinib but contain no medicine. Treatment dosing involves a specific dose of zasocitinib labeled as Dose A. During the study, participants will visit the clinic 12 times for assessments. Researchers will monitor the percentage of participants achieving a 75% reduction in HS symptoms at week 16 as the primary outcome. They will also track safety through adverse events and other measures throughout the 56 weeks of treatment. Participants will undergo evaluations including clinical exams, questionnaires, and safety tests to understand treatment effects and tolerability.

This research evaluates the long-term safety and effects of plozasiran in adults with hypertriglyceridemia HTG and severe hypertriglyceridemia SHTG. Participants must have completed prior related studies and meet specific health criteria, including controlled blood sugar levels HbA1c 10%. The study is designed as an open-label Phase 3 trial to extend understanding of this treatment in these populations. Participants will receive plozasiran injections under the skin approximately every three months for two years. They will continue following a low-fat diet according to local care standards. Some participants may join based on meeting additional criteria from previous studies, ensuring they fit the trials health requirements. During the study, participants will undergo regular assessments including monitoring for treatment-related side effects and changes in blood triglyceride and cholesterol levels. Researchers will track various blood markers and cardiovascular events over 24 months. Safety and response to treatment will be closely observed throughout the trial period.

Researchers are evaluating the performance of the Panuri test in detecting pancreatic ductal adenocarcinoma PDAC, the most common type of pancreatic cancer. This observational study focuses on adult patients who show symptoms suggesting pancreatic cancer or who are scheduled for procedures involving pancreatic cancer assessment. Panuri is a laboratory test designed to detect enzyme activity in urine samples related to PDAC, intended to support doctors in deciding if further imaging tests are needed. Participants will provide urine samples for the Panuri test during the study. The study includes two groups one with patients showing symptoms of pancreatic cancer and another with patients scheduled for pancreatic tissue assessment due to cancer suspicion. The test results will be kept blinded from both participants and physicians. Diagnosis confirmation will be done through review of electronic health records. Participants will be monitored from enrollment up to six months to assess how well the Panuri test detects PDAC. Data such as urine samples and medical records will be collected, but no treatment or intervention will be given as part of the study. The study aims to provide important information to help improve the diagnosis process for pancreatic cancer.

Researchers are evaluating the efficacy and safety of ICP-332 in adults aged 18 to 75 years with Prurigo Nodularis PN, a chronic skin condition characterized by itchy nodules. This phase 2, randomized, double-blind, placebo-controlled study aims to investigate different doses of ICP-332 for treating PN, addressing the need for effective therapies in patients with this condition. The trial is sponsored by Beijing InnoCare Pharma Tech Co., Ltd. and uses a parallel study design with multiple groups. Participants are randomly assigned to receive either ICP-332 at doses of 80 mg or 120 mg or a placebo. The study compares these groups over a period of up to 40 weeks, with primary assessment focusing on peak itch intensity using a numeric rating scale from baseline to week 16. Secondary measures include longer-term itch improvement, skin condition scores, quality of life assessments, drug concentration levels, and safety monitoring of adverse events from baseline through week 40. During the trial, participants will undergo regular evaluations including itch severity scales, skin assessments, quality of life questionnaires, and laboratory tests to monitor drug levels and safety. The study tracks outcomes up to 40 weeks to assess both efficacy and tolerability. Participants are expected to adhere to study visits and procedures as scheduled, with safety and treatment response closely monitored throughout the trial duration.