How Palleos Delivered Multi-Country Enrollment Amid COVID Restrictions And Geopolitical Disruptions

This case study, reviews an ongoing Phase III open-label extension study evaluating the long-term safety and efficacy of ublituximab, an FDA and EMA-approved monoclonal antibody, in patients with relapsing multiple sclerosis. Conducted across six countries, the trial has faced unique operational hurdles. The COVID-19 pandemic made in-person site initiation visits (SIVs) infeasible, while geopolitical disruptions led to the closure of Synevo laboratories in Russia and Belarus, jeopardizing essential lab services critical for patient safety monitoring and study continuity. In response, remote SIVs were implemented to avoid start-up delays, while taxi services were arranged to ensure safe, consistent patient transport amid public transit concerns. Additionally, COVID-19 testing costs were reimbursed to reduce patient burden.

To address lab service disruptions, alternative providers were sourced under compressed timelines, and temporary use of qualified local laboratories ensured uninterrupted safety monitoring. Despite these complex logistical challenges, the study continues to progress, with participants now in the extension phase following completion of the double-blind portion.