Back to resultsA Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)
Primary Purpose
Generalized Myasthenia Gravis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rozanolixizumab
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Myasthenia Gravis focused on measuring generalized Myasthenia Gravis, gMG, rozanolixizumab
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
Sites / Locations
- Mg0020 50092Recruiting
- Mg0020 50099Recruiting
- Mg0020 50561Recruiting
- Mg0020 50090Recruiting
- Mg0020 50560Recruiting
- Mg0020 50069Recruiting
- Mg0020 20161Recruiting
- Mg0020 20163Recruiting
- Mg0020 20165Recruiting
- Mg0020 20305Recruiting
- Mg0020 40135Recruiting
- Mg0020 40140Recruiting
- Mg0020 40177Recruiting
- Mg0020 40144Recruiting
- Mg0020 40146Recruiting
- Mg0020 40150Recruiting
- Mg0020 20068Recruiting
- Mg0020 20078Recruiting
- Mg0020 20077Recruiting
- Mg0020 20076Recruiting
- Mg0020 40155Recruiting
- Mg0020 40727Recruiting
- Mg0020 40153Recruiting
- Mg0020 40729Recruiting
- Mg0020 40160Recruiting
- Mg0020 40267Recruiting
- Mg0020 40308Recruiting
- Mg0020 40168Recruiting
- Mg0020 40163Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Rozanolixizumab Sequence 1: Syringe Driver - Manual Push
Rozanolixizumab Sequence 2: Manual Push - Syringe Driver
Arm Description
Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks.
Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks.
Outcomes
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
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05681715
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
April 23, 2024 (Anticipated)
Study Completion Date
April 23, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Myasthenia Gravis
Keywords
generalized Myasthenia Gravis, gMG, rozanolixizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rozanolixizumab Sequence 1: Syringe Driver - Manual Push
Arm Type
Experimental
Arm Description
Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks.
Arm Title
Rozanolixizumab Sequence 2: Manual Push - Syringe Driver
Arm Type
Experimental
Arm Description
Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks.
Intervention Type
Drug
Intervention Name(s)
Rozanolixizumab
Intervention Description
Rozanolixizumab self-administration via Syringe Driver or Manual Push.
Primary Outcome Measure Information:
Title
Successful self-administration of rozanolixizumab (with correct use of syringe driver and manual push, respectively) during the Self-administration Period at Visit 13
Description
Successful self-administration is defined by the participant (i) choosing the correct infusion site, (ii) administering subcutaneous, and (iii) delivering the intended dose.
Time Frame
Visit 13 (Week 12; last dose of Self-administration Period 1)
Title
Successful self-administration of rozanolixizumab (with correct use of syringe driver and manual push, respectively) during the Self-administration Period at Visit 19
Description
Successful self-administration is defined by the participant (i) choosing the correct infusion site, (ii) administering subcutaneous, and (iii) delivering the intended dose.
Time Frame
Visit 19 (Week 18; last dose of Self-administration Period 2)
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
From Visit 2 (Week 1) up to the End of Study Visit (Visit 21 [Week 26])
Title
Occurrence of local site reactions up to 24 hours after each administration during the Training Period and Self-administration Periods
Description
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.
Time Frame
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])
Title
Occurrence of medication errors associated with adverse reactions during the 2 Self-administration Periods of the study
Description
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.
Time Frame
During the Self-administration Periods (Visit 8 [Week 7] to Visit 19 [Week 18])
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
UCB Cares
Phone
1-844-599-2273 (USA)
Email
ucbcares@ucb.com
First Name & Middle Initial & Last Name or Official Title & Degree
UCB Cares
Phone
001 844 599 2273
Email
UCBCares@ucb.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273
Official's Role
Study Director
Facility Information:
Facility Name
Mg0020 50092
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Mg0020 50099
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Mg0020 50561
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Individual Site Status
Recruiting
Facility Name
Mg0020 50090
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
Mg0020 50560
City
Edmonton
Country
Canada
Individual Site Status
Recruiting
Facility Name
Mg0020 50069
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Name
Mg0020 20161
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Mg0020 20163
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Mg0020 20165
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Mg0020 20305
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Mg0020 40135
City
Gummersbach
Country
Germany
Individual Site Status
Recruiting
Facility Name
Mg0020 40140
City
Göttingen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Mg0020 40177
City
Münster
Country
Germany
Individual Site Status
Recruiting
Facility Name
Mg0020 40144
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Name
Mg0020 40146
City
Pavia
Country
Italy
Individual Site Status
Recruiting
Facility Name
Mg0020 40150
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Name
Mg0020 20068
City
Chiba-shi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mg0020 20078
City
Hanamaki-shi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mg0020 20077
City
Sendai
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mg0020 20076
City
Shinjuku-ku
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mg0020 40155
City
Gdansk
Country
Poland
Individual Site Status
Recruiting
Facility Name
Mg0020 40727
City
Lodz
Country
Poland
Individual Site Status
Recruiting
Facility Name
Mg0020 40153
City
Poznan
Country
Poland
Individual Site Status
Recruiting
Facility Name
Mg0020 40729
City
NIS
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Mg0020 40160
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Mg0020 40267
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Mg0020 40308
City
San Sebastián de Los Reyes
Country
Spain
Individual Site Status
Recruiting
Facility Name
Mg0020 40168
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Mg0020 40163
City
Oxford
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD Sharing Time Frame
Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD Sharing URL
https://www.Vivli.org
Learn more about this trial
A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)
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