A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)
An Open-label, Crossover Study to Evaluate Rozanolixizumab Self-administration by Study Participants With Generalized Myasthenia Gravis
2 other identifiers
interventional
62
10 countries
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2023
Shorter than P25 for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2023
CompletedFirst Posted
Study publicly available on registry
January 12, 2023
CompletedStudy Start
First participant enrolled
April 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2024
CompletedResults Posted
Study results publicly available
May 7, 2025
CompletedNovember 6, 2025
November 1, 2025
1 year
January 4, 2023
April 21, 2025
November 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Successful self-administration was defined by the participant (i) choosing the correct infusion site, (ii) administering SC, and (iii) delivering the intended dose.
Week 12 (last dose of Self-administration Period 1)
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)
Successful Self-administration was defined by the participant (i) choosing the correct infusion site, (ii) administering SC, and (iii) delivering the intended dose.
Week 18 (last dose of Self-administration Period 2)
Secondary Outcomes (3)
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])
From Week 1 up to the End of Study Visit (Week 26)
Percentage of Participants With Local Site Reactions up to 24 Hours After Each Administration During the Training Period and Self-administration Periods
Up to 24 hours after each administration during the Training Period (Baseline to Week 6) and Self-administration Periods (Week 7 to Week 18)
Percentage of Participants With Medication Errors Associated With Adverse Reactions During the 2 Self-administration Periods of the Study
During the Self-administration Periods (Week 7 to Week 18)
Study Arms (2)
Rozanolixizumab Sequence 1: Syringe Driver - Manual Push
EXPERIMENTALStudy participants will receive predefined weekly doses of rozanolixizumab for 18 weeks.
Rozanolixizumab Sequence 2: Manual Push - Syringe Driver
EXPERIMENTALStudy participants will receive predefined weekly doses of rozanolixizumab for 18 weeks.
Interventions
Rozanolixizumab self-administration via Syringe Driver or Manual Push.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Mg0020 50092
Orange, California, 92868, United States
Mg0020 50099
San Francisco, California, 94143, United States
Mg0020 50561
Lexington, Kentucky, 40536-0284, United States
Mg0020 50090
Winston-Salem, North Carolina, 27157, United States
Mg0020 50560
Edmonton, Canada
Mg0020 50069
Toronto, Canada
Mg0020 20161
Tbilisi, Georgia
Mg0020 20165
Tbilisi, Georgia
Mg0020 20305
Tbilisi, Georgia
Mg0020 40140
Göttingen, Germany
Mg0020 40177
Münster, Germany
Mg0020 40144
Milan, Italy
Mg0020 40146
Pavia, Italy
Mg0020 40150
Roma, Italy
Mg0020 20068
Chiba, Japan
Mg0020 20078
Hanamaki-shi, Japan
Mg0020 20077
Sendai, Japan
Mg0020 20076
Shinjuku-ku, Japan
Mg0020 40155
Gdansk, Poland
Mg0020 40727
Lodz, Poland
Mg0020 40153
Poznan, Poland
Mg0020 40729
Niš, Serbia
Mg0020 40160
Barcelona, Spain
Mg0020 40267
Barcelona, Spain
Mg0020 40308
San Sebastián de los Reyes, Spain
Mg0020 40168
Nottingham, United Kingdom
Mg0020 40163
Oxford, United Kingdom
Related Publications (1)
Bril V, Antozzi C, Berkowicz T, Druzdz A, Gandhi Mehta RK, Mahuwala ZK, Zschuntzsch J, Boehnlein M, Kerbusch V, Lavrov A, Morris M, Singh P, Leite MI. Self-administration of rozanolixizumab via manual push and infusion pump methods in patients with generalised myasthenia gravis: a randomised, phase 3, open-label, crossover study. J Neurol. 2025 Oct 11;272(10):686. doi: 10.1007/s00415-025-13420-6.
PMID: 41074934RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2023
First Posted
January 12, 2023
Study Start
April 17, 2023
Primary Completion
April 23, 2024
Study Completion
April 23, 2024
Last Updated
November 6, 2025
Results First Posted
May 7, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.