OncoMatch/Clinical Trials/NCT06149559
A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis
Is NCT06149559 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies rozanolixizumab for generalized myasthenia gravis.
Treatment: rozanolixizumab — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Biomarker criteria
Required: CHRNA1 autoantibody to acetylcholine receptor (AChR)
record confirming the presence of MG specific autoantibodies to acetylcholine receptor (AChR)
Required: MUSK autoantibody to muscle-specific kinase (MuSK)
record confirming the presence of MG specific autoantibodies to ... muscle-specific kinase (MuSK)
Disease stage
Required: Stage MGFA II, MGFA III, MGFA IVA (MGFA)
Excluded: Stage MGFA IVB, MGFA V
Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IVa at Screening
Demographics
Prior therapy
Must have received: conventional treatment for gMG (pyridostigmine, corticosteroids, immune suppressants)
has received existing conventional treatment(s) for gMG (eg, pyridostigmine, corticosteroids, and/or immune suppressants) prior to Screening
Cannot have received: thymectomy
Exception: allowed if >6 months prior to Screening
history of thymectomy within 6 months prior to Screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mg0006 50574 · Flower Mound, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06149559 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior thymectomy disqualifies patients from enrollment.
Does this trial require CHRNA1?
Yes, CHRNA1 autoantibody to acetylcholine receptor (AChR) is a required biomarker for enrollment.
Does this trial require MUSK?
Yes, MUSK autoantibody to muscle-specific kinase (MuSK) is a required biomarker for enrollment.
What disease stage is eligible?
Stage MGFA II or MGFA III or MGFA IVA is required.
Is there an age limit?
Yes. Patients must be 17 years or younger and at least 2 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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