Actively Recruiting
A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis
Led by UCB Biopharma SRL · Updated on 2026-05-08
12
Participants Needed
14
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be between 2 and under 18 years old at the time of consent
- Participants must have a documented diagnosis of generalized Myasthenia Gravis with confirmed antibodies to acetylcholine receptor or muscle-specific kinase
- Participants must have Myasthenia Gravis Foundation of America Clinical Classification II to IVa at screening
- Participants must have received conventional treatments for generalized Myasthenia Gravis prior to screening
- Participants must have had an unsatisfactory response or worsening symptoms and need additional therapy
You will not qualify if you...
- Participants with severe weakness affecting breathing or swallowing muscles, or experiencing a myasthenic crisis at screening or baseline
- Participants with known allergy to any components of the study medication or similar anti-neonatal-Fc receptor drugs
- Participants with active or untreated thymoma
- Participants who had thymectomy surgery within 6 months prior to screening
- Participants with active infections considered clinically relevant or serious infections requiring hospitalization or intravenous antibiotics within 6 weeks before treatment
- Participants who received a live vaccine within 4 weeks before baseline or plan to receive one during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Mg0006 50574
Denton, Texas, United States, 76208
Withdrawn
2
Mg0006 40290
Bologna, Italy
Actively Recruiting
3
Mg0006 40144
Milan, Italy
Actively Recruiting
4
Mg0006 40733
Naples, Italy
Actively Recruiting
5
Mg0006 20340
Fuchu-shi, Japan
Actively Recruiting
6
Mg0006 20339
Ōbu, Japan
Actively Recruiting
7
Mg0006 20343
Sagamihara, Japan
Actively Recruiting
8
Mg0006 40155
Warsaw, Poland
Actively Recruiting
9
Mg0006 40734
Warsaw, Poland
Actively Recruiting
10
Mg0006 20081
Taipei, Taiwan
Actively Recruiting
11
Mg0006 20095
Taipei, Taiwan
Actively Recruiting
12
Mg0006 40841
Altindağ/ankara, Turkey (Türkiye)
Actively Recruiting
13
Mg0006 40843
Ankara, Turkey (Türkiye)
Actively Recruiting
14
Mg0006 40836
Kocaeli, Turkey (Türkiye)
Actively Recruiting
Research Team
U
UCB Cares
CONTACT
U
UCB Cares
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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