Delivering An Early-Phase Autoimmune Trial Across Regions

By Deborah Spencer, Anthea Gates. and Claire Delaville

Early-phase autoimmune trials don’t follow the oncology playbook. This case study follows a Phase 1-2 rare rheumatology program across Europe and Asia-Pacific that hit every startup milestone early, including EU approval 13 days ahead of plan, and enrolled eight healthy volunteer groups back-to-back on schedule. The real test came when the study moved to patients. People living with chronic but non-life-threatening conditions, especially those already managing symptoms on approved treatments, have little reason to switch to an experimental therapy. Sites’ enthusiastic estimates of how many patients they could enroll didn’t translate into actual enrollment.

The team responded with changes grounded in enrollment data. They shifted country strategy toward regions with fewer treatment options and amended the protocol to include patients who had already tried several therapies. Read the full case study to learn how to plan realistic enrollment for chronic, non-acute conditions and keep your early-phase autoimmune study moving when patient behavior doesn’t match projections.