Clinical trial NCT05681715: A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)
Official title: An Open-label, Crossover Study to Evaluate Rozanolixizumab Self-administration by Study Participants With Generalized Myasthenia Gravis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Myasthenia Gravis
Keywords: generalized Myasthenia Gravis
gMG
rozanolixizumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2023-01-12
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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)
timeFrame: Week 12 (last dose of Self-administration Period 1)
measure: 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)
timeFrame: Week 18 (last dose of Self-administration Period 2)
Secondary outcomes:
measure: 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])
timeFrame: From Week 1 up to the End of Study Visit (Week 26)
measure: Percentage of Participants With Local Site Reactions up to 24 Hours After Each Administration During the Training Period and Self-administration Periods
timeFrame: Up to 24 hours after each administration during the Training Period (Baseline to Week 6) and Self-administration Periods (Week 7 to Week 18)
measure: Percentage of Participants With Medication Errors Associated With Adverse Reactions During the 2 Self-administration Periods of the Study
timeFrame: During the Self-administration Periods (Week 7 to Week 18)
Other outcomes:
Locations:
city: Orange
country: United States
facility: Mg0020 50092
state: California
city: San Francisco
country: United States
facility: Mg0020 50099
state: California
city: Lexington
country: United States
facility: Mg0020 50561
state: Kentucky
city: Winston-Salem
country: United States
facility: Mg0020 50090
state: North Carolina
city: Edmonton
country: Canada
facility: Mg0020 50560
city: Toronto
country: Canada
facility: Mg0020 50069
city: Tbilisi
country: Georgia
facility: Mg0020 20161
city: Tbilisi
country: Georgia
facility: Mg0020 20165
city: Tbilisi
country: Georgia
facility: Mg0020 20305
city: Göttingen
country: Germany
facility: Mg0020 40140
city: Münster
country: Germany
facility: Mg0020 40177
city: Milano
country: Italy
facility: Mg0020 40144
city: Pavia
country: Italy
facility: Mg0020 40146
city: Roma
country: Italy
facility: Mg0020 40150
city: Chiba-shi
country: Japan
facility: Mg0020 20068
city: Hanamaki-shi
country: Japan
facility: Mg0020 20078
city: Sendai
country: Japan
facility: Mg0020 20077
city: Shinjuku-ku
country: Japan
facility: Mg0020 20076
city: Gdansk
country: Poland
facility: Mg0020 40155
city: Lodz
country: Poland
facility: Mg0020 40727
city: Poznan
country: Poland
facility: Mg0020 40153
city: NIS
country: Serbia
facility: Mg0020 40729
city: Barcelona
country: Spain
facility: Mg0020 40160
city: Barcelona
country: Spain
facility: Mg0020 40267
city: San Sebastián de Los Reyes
country: Spain
facility: Mg0020 40308
city: Nottingham
country: United Kingdom
facility: Mg0020 40168
city: Oxford
country: United Kingdom
facility: Mg0020 40163
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: