Llandough

Researchers are evaluating the use of epigenome-guided treatment selection compared to the usual standard-of-care (SOC) treatment in adults with active Crohn's Disease (CD) who are starting biologic therapy. This multicenter, prospective, randomized, controlled, open-label study aims to assess the efficacy, safety, and cost-effectiveness of this approach by comparing clinical remission and endoscopic response at Week 26. About 378 participants with active CD, defined by specific clinical and endoscopic criteria, will be included, with roughly half being biologic-naive and the other half exposed to no more than one prior biologic treatment. Participants will be randomly assigned to either receive biologic therapy guided by an epigenetic biomarker assay and the EpiPredict software, which predicts response to two biologics (Vedolizumab or Ustekinumab) or to receive treatment selected according to usual SOC without epigenome guidance. Biologic therapies will be administered following product labels and local SOC recommendations, with dose adjustments allowed as needed. Study assessments will follow the SOC schedule for each biologic during the 26-week treatment period, with different visit weeks depending on the biologic used. Participants will undergo blood sample collection for epigenetic testing during screening. Study visits will include clinical and endoscopic assessments at specified weeks, with long-term follow-up every six months up to 24 months after Week 26 using medical records and questionnaires. Researchers will measure outcomes related to clinical remission and endoscopic response, safety, and cost-effectiveness. Participants' adherence and ability to comply with protocol requirements will be monitored throughout the study.

Chronic obstructive pulmonary disease (COPD) is a common lung condition affecting about 10% of adults worldwide, with a prevalence of 4.5% in those aged 40 years and older in the UK. Exacerbations, or sudden worsening episodes often triggered by infections, can lead to hospital admissions and carry risks of increased illness and death. This trial focuses on the high-risk 90-day period after hospital discharge, during which patients have a 43% chance of readmission and 12% risk of mortality. The study aims to test whether a supported rescue pack management plan can reduce readmissions by 20%. This is a Phase 3, open-label, multicenter randomized controlled trial involving 1400 patients across 30 NHS trusts.