Panevezys

This research aims to evaluate the efficacy and safety of duvakitug in people with moderately to severely active Ulcerative Colitis UC. It is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study that includes participants aged 16 to 80 years. The study is sponsored by Sanofi and focuses on assessing clinical remission and other important health outcomes in UC. Participants receive subcutaneous injections of duvakitug or placebo according to protocol. The study includes a 40-week Pivotal Maintenance Sub-Study followed by a 240-week Open-Label Extension OLE Sub-Study for those who continue. Those not entering the OLE will have a 45-day follow-up after the maintenance period. There are up to 32 on-site visits in total, with 21 visits during the maintenance phase and 11 during the extension. During the study, participants will have clinical assessments including endoscopy to evaluate remission and mucosal healing, symptom tracking such as bowel urgency and abdominal pain, and quality of life questionnaires. Safety is monitored through adverse event reporting and blood tests for drug concentrations and antibodies. The primary outcome is the proportion of participants achieving clinical remission by the modified Mayo Score at Week 40, with follow-up continuing up to 286 weeks for some participants.

Crohns disease is a chronic condition causing severe inflammation in the digestive tract, mainly affecting the bowels, and leading to symptoms like belly pain, diarrhea, tiredness, and weight loss. This trial is evaluating several targeted therapies for adults with moderate to severe Crohns disease. The study involves around 540 adults and aims to assess how well these treatments work and monitor any side effects over time. The treatments being studied include risankizumab, trosunilimab, lutikizumab, and ABBV-8736. These medicines are given either by injection under the skin or infusion into a vein, depending on the drug. Participants will be randomly assigned to receive one of several treatment combinations or monotherapies, with some continuing risankizumab alone for up to 72 weeks. Participants will attend regular hospital or clinic visits for medical assessments, blood tests, and endoscopies to check the effects of treatment. Researchers will also monitor side effects, collect daily diary information, and use questionnaires. Key outcomes include the percentage of participants achieving endoscopic remission by week 12 and tracking adverse events for up to about 96 weeks.