Clinical Trial

A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis

Study acronym: roMyG
Active, Not Recruiting Phase 2/3
View on ClinicalTrials.gov →
Summary
The purpose of the study is to assess the safety and tolerability of subcutaneous (sc) administration of rozanolixizumab in pediatric participants aged ≥2 to \<18 years with generalized Myasthenia Gravis (gMG).
Protocol Amendment History 5 changes
notable Enrollment increased: 12 -> 14 participants 2026-08-01
notable Trial sites reduced: 13 -> 9 locations 2026-07-19
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-06-26
notable Primary completion pushed: 2026-06-08 -> 2026-08-10 2026-06-26
minor Completion pushed: 2026-08-17 -> 2026-10-19 2026-06-26
Trial Details
NCT Number NCT06149559
Lead Sponsor UCB Biopharma SRL
Conditions Generalized Myasthenia Gravis
Enrollment 14 participants
Start Date 2024-06-14
Primary Completion 2026-08-10 (estimated)
Study Completion 2026-10-19 (estimated)
Updated on ClinicalTrials.gov 2026-08-14