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

November 3, 2025 updated by: UCB Biopharma SRL

An Open-label, Crossover Study to Evaluate Rozanolixizumab Self-administration by Study Participants With Generalized Myasthenia Gravis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Edmonton, Canada
        • Mg0020 50560
      • Toronto, Canada
        • Mg0020 50069
  • Georgia
      • Tbilisi, Georgia
        • Mg0020 20161
      • Tbilisi, Georgia
        • Mg0020 20165
      • Tbilisi, Georgia
        • Mg0020 20305
  • Germany
      • Göttingen, Germany
        • Mg0020 40140
      • Münster, Germany
        • Mg0020 40177
  • Italy
      • Milan, Italy
        • Mg0020 40144
      • Pavia, Italy
        • Mg0020 40146
      • Roma, Italy
        • Mg0020 40150
  • Japan
      • Chiba, Japan
        • Mg0020 20068
      • Hanamaki-shi, Japan
        • Mg0020 20078
      • Sendai, Japan
        • Mg0020 20077
      • Shinjuku-ku, Japan
        • Mg0020 20076
  • Poland
      • Gdansk, Poland
        • Mg0020 40155
      • Lodz, Poland
        • Mg0020 40727
      • Poznan, Poland
        • Mg0020 40153
  • Serbia
      • Niš, Serbia
        • Mg0020 40729
  • Spain
      • Barcelona, Spain
        • Mg0020 40160
      • Barcelona, Spain
        • Mg0020 40267
      • San Sebastián de los Reyes, Spain
        • Mg0020 40308
  • United Kingdom
      • Nottingham, United Kingdom
        • Mg0020 40168
      • Oxford, United Kingdom
        • Mg0020 40163
  • United States
    • California
      • Orange, California, United States, 92868
        • Mg0020 50092
      • San Francisco, California, United States, 94143
        • Mg0020 50099
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0284
        • Mg0020 50561
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Mg0020 50090

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rozanolixizumab Sequence 1: Syringe Driver - Manual Push
Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks.
Drug: Rozanolixizumab
Rozanolixizumab self-administration via Syringe Driver or Manual Push.
Experimental: Rozanolixizumab Sequence 2: Manual Push - Syringe Driver
Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks.
Drug: Rozanolixizumab
Rozanolixizumab self-administration via Syringe Driver or Manual Push.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Week 12 (last dose of Self-administration Period 1)
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)
Time Frame: Week 18 (last dose of Self-administration Period 2)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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])
Time Frame: From Week 1 up to the End of Study Visit (Week 26)
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as an AE starting on or after the date of first administration of rozanolixizumab in the study, up to and including 8 weeks (56 days) after the final dose.
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
Time Frame: Up to 24 hours after each administration during the Training Period (Baseline to Week 6) and Self-administration Periods (Week 7 to Week 18)
The local site reactions up to 24 hours after each administration were defined as AEs reported as local site reactions as per case report form within one day after RLZ administration.
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
Time Frame: During the Self-administration Periods (Week 7 to Week 18)
Medication errors were defined as an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the study participant. Medication Errors associated with adverse reactions during the 2 Self-administration Periods were measured.
During the Self-administration Periods (Week 7 to Week 18)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Biopharma SRL

Investigators

  • Study Director: UCB Cares, 001 844 599 2273

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Actual)

April 23, 2024

Study Completion (Actual)

April 23, 2024

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Estimated)

November 6, 2025

Last Update Submitted That Met QC Criteria

November 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MG0020
  • 2022-003870-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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