Autoimmune and rare autoimmune diseases are biologically heterogeneous, and that heterogeneity shows up in every trial as a gap between the screened population and the evaluable one. Biomarker-informed eligibility is how sponsors close that gap. The biomarker thresholds chosen at protocol stage shape screening yield and the quality of the Phase II signal, which is why enrollment performance in autoimmune and rare autoimmune trials is largely set before the first site activates.
This white paper sets out how biomarker-informed eligibility design translates into enrollment outcomes, with examples from IBD, lupus nephritis, SLE, and rheumatoid arthritis programs.
Read the paper for:
- The utility of biomarkers in autoimmune and rare autoimmune trials
- How biomarker choice and threshold setting affect enrollment yield
- What a biomarker-informed eligibility framework enables for sponsors designing Phase II programs
