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

Generalized Myasthenia Gravis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05681715
• Other study ID #: MG0020
• Secondary ID: 2022-003870-21
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 17, 2023
• Est. completion date: April 24, 2024

Study information

• Verified date: April 2024
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: April 24, 2024
• Est. primary completion date: April 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Generalized Myasthenia Gravis
• Muscle Weakness
• Myasthenia Gravis

Intervention

Drug:
• Rozanolixizumab
Rozanolixizumab self-administration via Syringe Driver or Manual Push.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Canada,  Georgia,  Germany,  Italy,  Japan,  Poland,  Serbia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful self-administration of rozanolixizumab (with correct use of syringe driver and manual push, respectively) during the Self-administration Period at Visit 13	Successful self-administration is defined by the participant (i) choosing the correct infusion site, (ii) administering subcutaneous, and (iii) delivering the intended dose.	Visit 13 (Week 12; last dose of Self-administration Period 1)
Primary	Successful self-administration of rozanolixizumab (with correct use of syringe driver and manual push, respectively) during the Self-administration Period at Visit 19	Successful self-administration is defined by the participant (i) choosing the correct infusion site, (ii) administering subcutaneous, and (iii) delivering the intended dose.	Visit 19 (Week 18; last dose of Self-administration Period 2)
Secondary	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	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.	From Visit 2 (Week 1) up to the End of Study Visit (Visit 21 [Week 26])
Secondary	Occurrence of local site reactions up to 24 hours after each administration during the Training Period and Self-administration Periods	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.	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])
Secondary	Occurrence of medication errors associated with adverse reactions during the 2 Self-administration Periods of the study	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.	During the Self-administration Periods (Visit 8 [Week 7] to Visit 19 [Week 18])