An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis

Enrolling by invitation · Phase 3

Conditions studied: Generalized Myasthenia Gravis

In brief

The purpose of the study is to assess the long term safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in pediatric participants with generalized Myasthenia Gravis (gMG) aged ≥2 at the time of the Screening Visit of MG0006.

Key facts

Study ID

NCT06540144

Run by

UCB Biopharma SRL

People needed

12

Starts

2024-10-08

Expected to finish

2027-08-17

Last updated by the study team

2026-07-06

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Study participant must meet one of the following:
• Study participant completed MG0006 according to the protocol
• Study participant completed the MG0006 Treatment Period and has a worsening of generalized myasthenia gravis (gMG) symptoms in the Observation Period of MG0006

You may not qualify if…

• Study participant met any mandatory withdrawal or mandatory permanent investigational medicinal product (IMP) discontinuation criteria in MG0006 or permanently discontinued IMP
• Study participant has a known hypersensitivity to any components of the IMP or other neonatal Fc receptor (FcRn) drugs
• Study participant has any laboratory abnormality that, in the opinion of the Investigator, is clinically significant, has not resolved at Baseline, and could jeopardize or compromise the study participant's ability to participate in this study

Where it is running

• Mg0008 40290 — Bologna, Italy
• Mg0008 40144 — Milan, Italy
• Mg0008 40733 — Naples, Italy
• Mg0008 20340 — Fuchu-shi, Japan
• Mg0008 20339 — Ōbu, Japan
• Mg0008 20343 — Sagamihara, Japan
• Mg0008 40155 — Warsaw, Poland
• Mg0008 40734 — Warsaw, Poland
• Mg0008 20081 — Taipei, Taiwan
• Mg0008 20095 — Taipei, Taiwan

Full record on ClinicalTrials.gov

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