Skip to main content
OpenTrials
Completed

NCT Number: NCT05681715

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Generalized Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Myasthenia Gravis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mg0020 50560, Edmonton, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rozanolixizumab

Drug

Rozanolixizumab self-administration via Syringe Driver or Manual Push.

Primary outcomes

  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 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.

  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 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 12, 2023
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.