A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Successful self-administration of rozanolixizumab (with correct use of syringe driver and manual push, respectively) during the Self-administration Period at Visit 13 [Visit 13 (Week 12; last dose of Self-administration Period 1)]
Successful self-administration is defined by the participant (i) choosing the correct infusion site, (ii) administering subcutaneous, and (iii) delivering the intended dose.
- Successful self-administration of rozanolixizumab (with correct use of syringe driver and manual push, respectively) during the Self-administration Period at Visit 19 [Visit 19 (Week 18; last dose of Self-administration Period 2)]
Successful self-administration is defined by the participant (i) choosing the correct infusion site, (ii) administering subcutaneous, and (iii) delivering the intended dose.
Secondary Outcome Measures
- Occurrence of Treatment-Emergent Adverse Events (TEAEs) after syringe driver or manual push self-administration from Visit 2 up to the End of Study Visit [From Visit 2 (Week 1) up to the End of Study Visit (Visit 21 [Week 26])]
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does 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.
- Occurrence of 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 Visit 7 [Week 6] and Self-administration Periods (Visit 8 [Week 7] to Visit 19 [Week 18])]
Local site reaction Adverse Events (AEs) will be considered treatment-emergent up to 24 hours after each administration during the Training Period and Self-administration Periods.
- Occurrence of medication errors associated with adverse reactions during the 2 Self-administration Periods of the study [During the Self-administration Periods (Visit 8 [Week 7] to Visit 19 [Week 18])]
Medication errors are 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 will be measured.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG)
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Study participant is willing to perform and capable of performing home self-administration
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Study participant is considered by the investigator for additional rozanolixizumab treatment with the posology proposed in this study.
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Body weight ≥35 kg
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Study participants may be male or female
Exclusion Criteria:
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Study participant has a known hypersensitivity to any components of the study medication or other anti-neonatal Fc receptor (FcRn) medications
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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)
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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
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The study participant previously participated in any rozanolixizumab MG study and met any mandatory withdrawal or mandatory study drug discontinuation criteria
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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
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- UCB Biopharma SRL
Investigators
- Study Director: UCB Cares, 001 844 599 2273
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MG0020
- 2022-003870-21