Phase 3 N=62 Randomized Treatment

A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)

Generalized Myasthenia Gravis

Bottom Line

View on ClinicalTrials.gov: NCT05681715 ↗

Enrolled (actual)

Serious AEs

5.2%

Results posted

May 2025

Primary outcome: Primary: Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 13 (Week 12) — 100; 100 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rozanolixizumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: UCB Biopharma SRL
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 13 (Week 12)	100; 100	—
PRIMARY Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 19 (Week 18)	100; 100	—
SECONDARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) After Syringe Driver or Manual Push Self-administration From Visit 2 (Week 1) up to the End of Study Visit (Visit 21 [Week 26])	35.7; 29.6; 26.9; 38.5; 75.8	—
SECONDARY Percentage of Participants With Local Site Reactions up to 24 Hours After Each Administration During the Training Period and Self-administration Periods	0; 0; 0; 0; 0	—
SECONDARY Percentage of Participants With Medication Errors Associated With Adverse Reactions During the 2 Self-administration Periods of the Study	0; 0; 0; 0	—

Summary

The purpose of this study is to evaluate the ability of study participants with generalized Myasthenia Gravis (gMG) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods.

Eligibility Criteria

Inclusion Criteria

Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG)
Study participant is willing to perform and capable of performing home self-administration
Study participant is considered by the investigator for additional rozanolixizumab treatment with the posology proposed in this study.
Body weight ≥35 kg
Study participants may be male or female

Exclusion Criteria

Study participant has a known hypersensitivity to other anti-Fc receptor (FcRn) medications, to any components of the study medication, to any of the excipients (including polysorbate 80), or has a known history of hyperprolinemia, since both polysorbate 80 and L-proline are constituents of the rozanolixizumab formulation
Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current or history of nontuberculous mycobacterial infection (NTMBI)
Study participant has a clinically relevant active infection or a history of serious infection (resulting in hospitalization or requiring IV antibiotic treatment) within 6 weeks before the Baseline Visit
The study participant previously participated in any rozanolixizumab MG study and met any mandatory withdrawal criteria (unless the reason is directly related to MG0020 participation) or mandatory study drug discontinuation criteria.
Study participant has received a live vaccination within 4 weeks before starting treatment, or a Bacillus Calmette-Guérin (BCG) vaccine within 1 year before starting treatment; or intends to have a live vaccination during the course of the study or within 8 weeks following the last dose of rozanolixizumab
Study participant with severe (defined as Grade 3 on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05681715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.