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A new GSK–University of Oxford clinical trial is using advanced biomarker science to build a more detailed understanding of ulcerative colitis and investigate a potential new treatment approach.
The PEGASUS study marks the first clinical activity within a five-year Experimental Medicine Collaboration between GSK and the University of Oxford, backed by £10 million in funding. The Phase 1b, open-label study is investigating an anti-interleukin-18, or IL-18, monoclonal antibody in adults with moderate-to-severely active ulcerative colitis.
Ulcerative colitis is a chronic inflammatory bowel disease in which the immune system contributes to inflammation and damage in the colon. Although treatment options have expanded, many patients do not achieve a lasting response, underlining the need for a clearer understanding of the biological processes that drive disease.
PEGASUS has been designed as a flexible clinical research platform, allowing targeted interventions to be assessed through dedicated sub-studies. This structure could support the efficient evaluation of future investigational treatments while generating insight into the molecular changes associated with disease and treatment response.
The trial’s biomarker programme will use single-cell RNA analysis, spatial transcriptomics and advanced proteomics. Together, these techniques can help researchers examine which cells are active in diseased tissue, how they are organised within the gut and how proteins change over time.
Researchers will analyse samples from the gut and blood at multiple points during the study. The aim is to establish whether blocking IL-18 can shift biological markers associated with ulcerative colitis towards a healthier state. This may help identify the patients most likely to benefit from a particular treatment approach and inform the design of future studies.
The clinical site reached full participant recruitment within 72 hours of activation, demonstrating strong interest in research focused on new options for people living with ulcerative colitis.
For laboratory professionals, the study highlights how translational medicine increasingly depends on integrated workflows across clinical research, genomics, pathology and data science. Generating useful insight from complex molecular techniques requires consistent sample collection, robust pre-analytical processes, validated analytical methods and careful interpretation.
The PEGASUS trial provides a clear example of how multi-omics technologies are being incorporated into early-phase clinical development. As these methods become more widely used, laboratories will play a central role in translating high-dimensional biological data into evidence that can support more precise, patient-focused care.
