NCT06149559

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

An Open-label, Single-arm Study Evaluating the Activity, Safety, and Pharmacokinetics of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Generalized Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	rozanolixizumab	rozanolixizumab solution for injection

Timeline

• Start date: 2024-06-14
• Primary completion: 2026-06-08
• Completion: 2026-08-17
• First posted: 2023-11-29
• Last updated: 2026-04-14

Locations

13 sites across 6 countries: United States, Italy, Japan, Poland, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study