A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)
- Registration Number
- NCT05681715
- Lead Sponsor
- UCB Biopharma SRL
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Rozanolixizumab Sequence 1: Syringe Driver - Manual Push Rozanolixizumab Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks. Rozanolixizumab Sequence 2: Manual Push - Syringe Driver Rozanolixizumab Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks.
- Primary Outcome Measures
Name Time Method 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) 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.
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) 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 Outcome Measures
Name Time Method 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) 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.
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) 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.
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) 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.
Trial Locations
- Locations (27)
Mg0020 40729
🇷🇸NIS, Serbia
Mg0020 50099
🇺🇸San Francisco, California, United States
Mg0020 40150
🇮🇹Roma, Italy
Mg0020 50092
🇺🇸Orange, California, United States
Mg0020 50561
🇺🇸Lexington, Kentucky, United States
Mg0020 50090
🇺🇸Winston-Salem, North Carolina, United States
Mg0020 50560
🇨🇦Edmonton, Canada
Mg0020 20161
🇬🇪Tbilisi, Georgia
Mg0020 50069
🇨🇦Toronto, Canada
Mg0020 20305
🇬🇪Tbilisi, Georgia
Mg0020 20165
🇬🇪Tbilisi, Georgia
Mg0020 40140
🇩🇪Göttingen, Germany
Mg0020 40144
🇮🇹Milano, Italy
Mg0020 40177
🇩🇪Münster, Germany
Mg0020 20068
🇯🇵Chiba-shi, Japan
Mg0020 20078
🇯🇵Hanamaki-shi, Japan
Mg0020 40146
🇮🇹Pavia, Italy
Mg0020 40155
🇵🇱Gdansk, Poland
Mg0020 20077
🇯🇵Sendai, Japan
Mg0020 20076
🇯🇵Shinjuku-ku, Japan
Mg0020 40727
🇵🇱Lodz, Poland
Mg0020 40160
🇪🇸Barcelona, Spain
Mg0020 40153
🇵🇱Poznan, Poland
Mg0020 40267
🇪🇸Barcelona, Spain
Mg0020 40308
🇪🇸San Sebastián de Los Reyes, Spain
Mg0020 40168
🇬🇧Nottingham, United Kingdom
Mg0020 40163
🇬🇧Oxford, United Kingdom