Matal

Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.

Researchers are evaluating the efficacy and safety of pegozafermin in adults with compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis MASH, previously known as nonalcoholic steatohepatitis NASH. This study focuses on participants with biopsy-confirmed advanced liver fibrosis stage F4 due to MASH. The research aims to understand how pegozafermin affects liver health over time compared to a placebo. Participants will receive either pegozafermin or a matched placebo through subcutaneous injections. The study follows a randomized, parallel design with quadruple masking to ensure unbiased results. The treatment period extends up to 24 months, with additional long-term follow-up lasting up to five years to assess disease progression and liver fibrosis regression. During the study, participants will undergo various assessments including measurements of liver fibrosis, disease progression through clinical events, and liver function tests such as alanine aminotransferase ALT levels. Tools like Enhanced Liver Fibrosis ELF score and FibroScan Vibration-controlled Transient Elastography VCTE will be used to monitor liver condition up to 60 months. Safety and efficacy will be closely monitored throughout the study period, which may last up to seven years in total.

Researchers are evaluating the safety and effectiveness of ficerafusp alfa combined with pembrolizumab compared to placebo with pembrolizumab for adults with first-line PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma. This study focuses on the dual targeting of EGFR and TGF-beta, which contribute to tumor growth and spread. It includes both phase 2 and phase 3 parts to identify the best dose and to compare treatment outcomes. In phase 2, participants are randomized into three groups receiving either higher or lower doses of ficerafusp alfa plus pembrolizumab, or placebo plus pembrolizumab. In phase 3, participants receive the selected optimal biologic dose of ficerafusp alfa with pembrolizumab or placebo with pembrolizumab in a 21 ratio. Treatments are given weekly or every three weeks depending on the drug, with careful monitoring throughout the study. Participants will undergo tumor biopsies or provide archival tissue, and receive regular assessments including imaging scans and lab tests to measure tumor response and safety. Researchers will track side effects, response rates, survival, and quality of life using standardized criteria over approximately 1 to 3 years. Safety monitoring continues up to 90 days after treatment ends. The total study duration extends through long-term follow-up to evaluate overall outcomes.