A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis
NCT ID: NCT06149559
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
12 participants
INTERVENTIONAL
2024-06-14
2026-08-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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rozanolixizumab
Study participants will receive pre-defined doses of rozanolixizumab for 6 weeks.
rozanolixizumab
rozanolixizumab solution for injection
Interventions
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rozanolixizumab
rozanolixizumab solution for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG) at Screening that includes a record confirming the presence of MG specific autoantibodies to acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) prior to Screening
* Study participant has Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IVa at Screening
* Study participant has received existing conventional treatment(s) for gMG (eg, pyridostigmine, corticosteroids, and/or immune suppressants) prior to Screening
* Study participant has had an unsatisfactory clinical response or worsening of gMG symptoms and is in need of additional therapy (for example, plasma exchange (PEX) or treatment with intravenous immunoglobulin (IVIg))
Exclusion Criteria
* Study participant has a known hypersensitivity to any components of the Investigational Medicinal Product (IMP) or other anti-neonatal-Fc receptor (FcRn) medications
* Study participant with any active or untreated thymoma
* Study participant has a history of thymectomy within 6 months prior to Screening
* Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of IMP
* Study participant has received a live vaccination within 4 weeks prior to Baseline or intends to have a live vaccination during the course of the study
2 Years
17 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
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Mg0006 50574
Denton, Texas, United States
Mg0006 40290
Bologna, , Italy
Mg0006 40144
Milan, , Italy
Mg0006 40733
Napoli, , Italy
Mg0006 20340
Fuchu-shi, , Japan
Mg0006 20339
Ōbu, , Japan
Mg0006 20343
Sagamihara, , Japan
Mg0006 40734
Lodz, , Poland
Mg0006 40155
Warsaw, , Poland
Mg0006 20081
Taipei, , Taiwan
Mg0006 20095
Taipei, , Taiwan
Mg0006 40836
Kocaeli, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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2022-502074-16-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1285-0787
Identifier Type: OTHER
Identifier Source: secondary_id
MG0006
Identifier Type: -
Identifier Source: org_study_id