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A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Primary Purpose

Generalized Myasthenia Gravis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rozanolixizumab
Placebo
Sponsored by
UCB Biopharma SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Myasthenia Gravis focused on measuring UCB7665, generalized myasthenia gravis, rozanolixizumab, gMG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Study participant must be ≥18 years of age, at the time of signing the informed consent
  • Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at Visit 1, based on study participant's history and supported by previous evaluations
  • Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) at Screening (Visit 1).The presence of autoantibodies may be confirmed with repeat testing at Visit 1
  • Study participant has Myasthenia Gravis Foundation of America (MGFA) Class II to IVa at Visit 1
  • Study participant with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of at least 3 (with ≥3 points from non-ocular symptom) AND a quantitative myasthenia gravis (QMG) score of at least 11 at Visit 1 and at Baseline (Visit 2)
  • Study participant is considered for additional treatment such as intravenous immunoglobulin g (IVIg) or plasma exchange (PEX) by the Investigator

Exclusion Criteria:

  • Study participant has a known history of hyperprolinemia
  • Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP)
  • Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI) will be excluded
  • Study participant has experienced hypersensitivity reaction after exposure to other anti-neonatal Fc receptor (FcRn) drugs
  • 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 at Visit 1 or Visit 2
  • Study participant has a history of a solid organ transplant or hematopoietic stem cell/marrow transplant

Sites / Locations

  • Mg0003 50081
  • Mg0003 50082
  • Mg0003 50072
  • Mg0003 50092
  • Mg0003 50097
  • Mg0003 50099
  • Mg0003 50101
  • Mg0003 50088
  • Mg0003 50122
  • Mg0003 50120
  • Mg0003 50073
  • Mg0003 50075
  • Mg0003 50323
  • Mg0003 50109
  • Mg0003 50114
  • Mg0003 50074
  • Mg0003 50121
  • Mg0003 50110
  • Mg0003 50102
  • Mg0003 50104
  • Mg0003 50105
  • Mg0003 50077
  • Mg0003 50117
  • Mg0003 50086
  • Mg0003 50090
  • Mg0003 50076
  • Mg0003 50096
  • Mg0003 50089
  • Mg0003 50084
  • Mg0003 50113
  • Mg0003 40121
  • Mg0003 50067
  • Mg0003 50066
  • Mg0003 50070
  • Mg0003 50069
  • Mg0003 40125
  • Mg0003 40124
  • Mg0003 40128
  • Mg0003 40127
  • Mg0003 40126
  • Mg0003 40489
  • Mg0003 40129
  • Mg0003 40070
  • Mg0003 40512
  • Mg0003 40510
  • Mg0003 40360
  • Mg0003 40426
  • Mg0003 40130
  • Mg0003 40017
  • Mg0003 40132
  • Mg0003 40133
  • Mg0003 40131
  • Mg0003 20160
  • Mg0003 20161
  • Mg0003 20163
  • Mg0003 20165
  • Mg0003 40134
  • Mg0003 40135
  • Mg0003 40140
  • Mg0003 40139
  • Mg0003 40078
  • Mg0003 40177
  • Mg0003 40082
  • Mg0003 40178
  • Mg0003 40283
  • Mg0003 40149
  • Mg0003 40144
  • Mg0003 40307
  • Mg0003 40146
  • Mg0003 40148
  • Mg0003 40150
  • Mg0003 20035
  • Mg0003 20068
  • Mg0003 20078
  • Mg0003 20079
  • Mg0003 20075
  • Mg0003 20071
  • Mg0003 20067
  • Mg0003 20077
  • Mg0003 20070
  • Mg0003 20076
  • Mg0003 20032
  • Mg0003 20074
  • Mg0003 40155
  • Mg0003 40151
  • Mg0003 40153
  • Mg0003 40154
  • Mg0003 20168
  • Mg0003 20027
  • Mg0003 20169
  • Mg0003 20001
  • Mg0003 20028
  • Mg0003 20029
  • Mg0003 20055
  • Mg0003 20197
  • Mg0003 40468
  • Mg0003 40467
  • Mg0003 40159
  • Mg0003 40160
  • Mg0003 40267
  • Mg0003 40157
  • Mg0003 40161
  • Mg0003 40162
  • Mg0003 40350
  • Mg0003 40341
  • Mg0003 40308
  • Mg0003 20080
  • Mg0003 20081
  • Mg0003 20086
  • Mg0003 20082
  • Mg0003 40175
  • Mg0003 40168

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dosage Regimen 1

Dosage Regimen 2

Placebo

Arm Description

Study participants randomized to dosage regimen 1 will receive assigned dosage of rozanolixizumab at pre-specified time points during Treatment Period.

Study participants randomized to dosage regimen 2 will receive assigned dosage of rozanolixizumab at pre-specified time points during Treatment Period.

Study participants randomized to this arm will receive placebo.

Outcomes

Primary Outcome Measures

Change From Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score
The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported outcome (PRO) instrument developed on the basis of the Quantitative Myasthenia Gravis (QMG). The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0 represents no symptoms or impaired performance and 3 represents the most severe symptoms or impaired performance. The total score ranges from 0 to 24, with a higher score indicating more disability. A positive change in the score indicates worsening and a negative change indicates improvement.

Secondary Outcome Measures

Percentage of Participants Achieving Myasthenia Gravis-Activities of Daily Living (MG-ADL) Response at Day 43
The MG-ADL is an 8-item PRO instrument developed on the basis of the QMG. The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0 represents no symptoms or impaired performance and 3 represents the most severe symptoms or impaired performance. The total score ranges from 0 to 24, with a higher score indicating more disability. A positive change in the score indicates worsening and a negative change indicates improvement. Study participants were classified as responders at Day 43 if the value was at least a 2-point improvement (decrease) from Baseline at Day 43.
Change From Baseline to Day 43 in Myasthenia Gravis-Composite (MG-C) Total Score
MG-C scale is a validated assessment and scale tests 10 items with individual item being weighted differently. The items included ptosis/upward gaze (range: 0 [>45 second] - 3 [Immediate]), double vision on lateral gaze (range: 0 [>45 second] - 4 [Immediate]), eye closure (range: 0 [Normal] - 2 [severe weakness]), talking (range: 0 [Normal] - 6 [difficult to understand speech]), chewing (range: 0 [Normal] - 6 [gastric tube]), swallowing (range: 0 [Normal] - 6 [gastric tube]), breathing (range: 0 [Normal] - 9 [ventilator dependence]), neck flexion (range: 0 [Normal] - 4 [severe weakness]), shoulder abduction (range: 0 [Normal] - 5 [severe weakness]) and hip flexion (range: 0 [Normal] - 5 [severe weakness]), lower scores= lower disease activity. Total MG-C score was obtained by summing responses to each individual item and score ranges from 0 to 50, with lower scores indicating lower disease activity. A positive change indicates worsening and a negative change indicates improvement.
Change From Baseline to Day 43 in Quantitative Myasthenia Gravis (QMG) Total Score
The QMG is a validated assessment and the scale tested 13 items, including ocular and facial involvement, swallowing, speech, limb strength, and forced vital capacity. The total QMG score was obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3) and the score ranges from 0 to 39, with lower scores indicating lower disease activity. A positive change in the score indicates worsening and a negative change indicates improvement.
Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score
MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants were asked to choose response option that how frequently they experienced muscle weakness fatigability (items 34-42) over the past 7 days using a 5-point Likert scale (1="none of the time" to 5="all of the time") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100. Total score is calculated as: (sum of item scores within the scale)/(raw score range) x (total number of items in the scale)/(number of non-missing items in the scale) x100 and ranged from 0 to 100, where higher scores indicated severe symptoms.
Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Physical Fatigue' Score
The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants were asked to choose the response option that how frequently they experienced physical fatigue (items 19-33) over the past 7 days using a 5-point Likert scale (1="none of the time" to 5="all of the time") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100. Total score is calculated as: (sum of item scores within the scale)/(raw score range) x (total number of items in the scale)/(number of non-missing items in the scale) x100 and ranged from 0 to 100, where higher scores indicated severe symptoms.
Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Bulbar Symptoms' Score
The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants were asked to choose response option that best described severity of bulbar muscle weakness (items 6-15) symptoms over past 7 days using a 4-point Likert scale (1="none" to 4="severe") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100. Total score is calculated as: (sum of item scores within the scale)/(raw score range) x (total number of items in the scale)/(number of non-missing items in the scale) x100 and ranged from 0 to 100, where higher scores indicated severe symptoms.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
A TEAE is defined as an AE starting on or after the time of first administration of investigational medicinal product (IMP) up to and including 8 weeks after the last dose.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal of Investigational Medicinal Product (IMP)
A TEAE is defined as an AE starting on or after the time of first administration of IMP up to and including 8 weeks after the last dose.

Full Information

First Posted
May 29, 2019
Last Updated
August 22, 2023
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT03971422
Brief Title
A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
October 26, 2021 (Actual)

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 the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Myasthenia Gravis
Keywords
UCB7665, generalized myasthenia gravis, rozanolixizumab, gMG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dosage Regimen 1
Arm Type
Experimental
Arm Description
Study participants randomized to dosage regimen 1 will receive assigned dosage of rozanolixizumab at pre-specified time points during Treatment Period.
Arm Title
Dosage Regimen 2
Arm Type
Experimental
Arm Description
Study participants randomized to dosage regimen 2 will receive assigned dosage of rozanolixizumab at pre-specified time points during Treatment Period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Study participants randomized to this arm will receive placebo.
Intervention Type
Drug
Intervention Name(s)
Rozanolixizumab
Other Intervention Name(s)
UCB7665
Intervention Description
Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Subjects will receive placebo at pre-specified time points.
Primary Outcome Measure Information:
Title
Change From Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score
Description
The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported outcome (PRO) instrument developed on the basis of the Quantitative Myasthenia Gravis (QMG). The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0 represents no symptoms or impaired performance and 3 represents the most severe symptoms or impaired performance. The total score ranges from 0 to 24, with a higher score indicating more disability. A positive change in the score indicates worsening and a negative change indicates improvement.
Time Frame
Baseline and Day 43
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Myasthenia Gravis-Activities of Daily Living (MG-ADL) Response at Day 43
Description
The MG-ADL is an 8-item PRO instrument developed on the basis of the QMG. The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0 represents no symptoms or impaired performance and 3 represents the most severe symptoms or impaired performance. The total score ranges from 0 to 24, with a higher score indicating more disability. A positive change in the score indicates worsening and a negative change indicates improvement. Study participants were classified as responders at Day 43 if the value was at least a 2-point improvement (decrease) from Baseline at Day 43.
Time Frame
Day 43
Title
Change From Baseline to Day 43 in Myasthenia Gravis-Composite (MG-C) Total Score
Description
MG-C scale is a validated assessment and scale tests 10 items with individual item being weighted differently. The items included ptosis/upward gaze (range: 0 [>45 second] - 3 [Immediate]), double vision on lateral gaze (range: 0 [>45 second] - 4 [Immediate]), eye closure (range: 0 [Normal] - 2 [severe weakness]), talking (range: 0 [Normal] - 6 [difficult to understand speech]), chewing (range: 0 [Normal] - 6 [gastric tube]), swallowing (range: 0 [Normal] - 6 [gastric tube]), breathing (range: 0 [Normal] - 9 [ventilator dependence]), neck flexion (range: 0 [Normal] - 4 [severe weakness]), shoulder abduction (range: 0 [Normal] - 5 [severe weakness]) and hip flexion (range: 0 [Normal] - 5 [severe weakness]), lower scores= lower disease activity. Total MG-C score was obtained by summing responses to each individual item and score ranges from 0 to 50, with lower scores indicating lower disease activity. A positive change indicates worsening and a negative change indicates improvement.
Time Frame
Baseline and Day 43
Title
Change From Baseline to Day 43 in Quantitative Myasthenia Gravis (QMG) Total Score
Description
The QMG is a validated assessment and the scale tested 13 items, including ocular and facial involvement, swallowing, speech, limb strength, and forced vital capacity. The total QMG score was obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3) and the score ranges from 0 to 39, with lower scores indicating lower disease activity. A positive change in the score indicates worsening and a negative change indicates improvement.
Time Frame
Baseline and Day 43
Title
Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score
Description
MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants were asked to choose response option that how frequently they experienced muscle weakness fatigability (items 34-42) over the past 7 days using a 5-point Likert scale (1="none of the time" to 5="all of the time") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100. Total score is calculated as: (sum of item scores within the scale)/(raw score range) x (total number of items in the scale)/(number of non-missing items in the scale) x100 and ranged from 0 to 100, where higher scores indicated severe symptoms.
Time Frame
Baseline and Day 43
Title
Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Physical Fatigue' Score
Description
The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants were asked to choose the response option that how frequently they experienced physical fatigue (items 19-33) over the past 7 days using a 5-point Likert scale (1="none of the time" to 5="all of the time") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100. Total score is calculated as: (sum of item scores within the scale)/(raw score range) x (total number of items in the scale)/(number of non-missing items in the scale) x100 and ranged from 0 to 100, where higher scores indicated severe symptoms.
Time Frame
Baseline and Day 43
Title
Change From Baseline to Day 43 in the Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Bulbar Symptoms' Score
Description
The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants were asked to choose response option that best described severity of bulbar muscle weakness (items 6-15) symptoms over past 7 days using a 4-point Likert scale (1="none" to 4="severe") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100. Total score is calculated as: (sum of item scores within the scale)/(raw score range) x (total number of items in the scale)/(number of non-missing items in the scale) x100 and ranged from 0 to 100, where higher scores indicated severe symptoms.
Time Frame
Baseline and Day 43
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
A TEAE is defined as an AE starting on or after the time of first administration of investigational medicinal product (IMP) up to and including 8 weeks after the last dose.
Time Frame
From Baseline until End of Study Visit (up to Week 14)
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal of Investigational Medicinal Product (IMP)
Description
A TEAE is defined as an AE starting on or after the time of first administration of IMP up to and including 8 weeks after the last dose.
Time Frame
From Baseline until End of Study Visit (up to Week 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Study participant must be ≥18 years of age, at the time of signing the informed consent Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at Visit 1, based on study participant's history and supported by previous evaluations Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) at Screening (Visit 1).The presence of autoantibodies may be confirmed with repeat testing at Visit 1 Study participant has Myasthenia Gravis Foundation of America (MGFA) Class II to IVa at Visit 1 Study participant with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of at least 3 (with ≥3 points from non-ocular symptom) AND a quantitative myasthenia gravis (QMG) score of at least 11 at Visit 1 and at Baseline (Visit 2) Study participant is considered for additional treatment such as intravenous immunoglobulin g (IVIg) or plasma exchange (PEX) by the Investigator Exclusion Criteria: Study participant has a known history of hyperprolinemia Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP) Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI) will be excluded Study participant has experienced hypersensitivity reaction after exposure to other anti-neonatal Fc receptor (FcRn) drugs 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 at Visit 1 or Visit 2 Study participant has a history of a solid organ transplant or hematopoietic stem cell/marrow transplant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Mg0003 50081
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Mg0003 50082
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Mg0003 50072
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Mg0003 50092
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Mg0003 50097
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Mg0003 50099
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Mg0003 50101
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Mg0003 50088
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Mg0003 50122
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Mg0003 50120
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Mg0003 50073
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Mg0003 50075
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Mg0003 50323
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Mg0003 50109
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Mg0003 50114
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Mg0003 50074
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Mg0003 50121
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Mg0003 50110
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mg0003 50102
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mg0003 50104
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mg0003 50105
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mg0003 50077
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mg0003 50117
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Mg0003 50086
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Mg0003 50090
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Mg0003 50076
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Mg0003 50096
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Mg0003 50089
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Mg0003 50084
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Mg0003 50113
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Mg0003 40121
City
Bruxelles
Country
Belgium
Facility Name
Mg0003 50067
City
Calgary
Country
Canada
Facility Name
Mg0003 50066
City
Montréal
Country
Canada
Facility Name
Mg0003 50070
City
Québec
Country
Canada
Facility Name
Mg0003 50069
City
Toronto
Country
Canada
Facility Name
Mg0003 40125
City
Ostrava
Country
Czechia
Facility Name
Mg0003 40124
City
Praha 2
Country
Czechia
Facility Name
Mg0003 40128
City
Aalborg
Country
Denmark
Facility Name
Mg0003 40127
City
Aarhus n
Country
Denmark
Facility Name
Mg0003 40126
City
Copenhagen
Country
Denmark
Facility Name
Mg0003 40489
City
Odense
Country
Denmark
Facility Name
Mg0003 40129
City
Bordeaux
Country
France
Facility Name
Mg0003 40070
City
Clermont-Ferrand
Country
France
Facility Name
Mg0003 40512
City
Garches
Country
France
Facility Name
Mg0003 40510
City
Le Kremlin-Bicêtre
Country
France
Facility Name
Mg0003 40360
City
Limoges
Country
France
Facility Name
Mg0003 40426
City
Lyon
Country
France
Facility Name
Mg0003 40130
City
Marseille
Country
France
Facility Name
Mg0003 40017
City
Nantes
Country
France
Facility Name
Mg0003 40132
City
Nice Cedex 1
Country
France
Facility Name
Mg0003 40133
City
Paris
Country
France
Facility Name
Mg0003 40131
City
Strasbourg
Country
France
Facility Name
Mg0003 20160
City
Tbilisi
Country
Georgia
Facility Name
Mg0003 20161
City
Tbilisi
Country
Georgia
Facility Name
Mg0003 20163
City
Tbilisi
Country
Georgia
Facility Name
Mg0003 20165
City
Tbilisi
Country
Georgia
Facility Name
Mg0003 40134
City
Essen
Country
Germany
Facility Name
Mg0003 40135
City
Gummersbach
Country
Germany
Facility Name
Mg0003 40140
City
Göttingen
Country
Germany
Facility Name
Mg0003 40139
City
Jena
Country
Germany
Facility Name
Mg0003 40078
City
Leipzig
Country
Germany
Facility Name
Mg0003 40177
City
Münster
Country
Germany
Facility Name
Mg0003 40082
City
Kistarcsa
Country
Hungary
Facility Name
Mg0003 40178
City
Nyiregyhaza
Country
Hungary
Facility Name
Mg0003 40283
City
Bologna
Country
Italy
Facility Name
Mg0003 40149
City
Lazio
Country
Italy
Facility Name
Mg0003 40144
City
Milano
Country
Italy
Facility Name
Mg0003 40307
City
Napoli
Country
Italy
Facility Name
Mg0003 40146
City
Pavia
Country
Italy
Facility Name
Mg0003 40148
City
Roma
Country
Italy
Facility Name
Mg0003 40150
City
Roma
Country
Italy
Facility Name
Mg0003 20035
City
Bunkyō-Ku
Country
Japan
Facility Name
Mg0003 20068
City
Chiba-Shi
Country
Japan
Facility Name
Mg0003 20078
City
Hanamaki-Shi
Country
Japan
Facility Name
Mg0003 20079
City
Hiroshima
Country
Japan
Facility Name
Mg0003 20075
City
Kobe
Country
Japan
Facility Name
Mg0003 20071
City
Nagasaki
Country
Japan
Facility Name
Mg0003 20067
City
Sapporo
Country
Japan
Facility Name
Mg0003 20077
City
Sendai
Country
Japan
Facility Name
Mg0003 20070
City
Shinjuku-Ku
Country
Japan
Facility Name
Mg0003 20076
City
Shinjuku-Ku
Country
Japan
Facility Name
Mg0003 20032
City
Suita
Country
Japan
Facility Name
Mg0003 20074
City
Ōsaka-sayama
Country
Japan
Facility Name
Mg0003 40155
City
Gdańsk
Country
Poland
Facility Name
Mg0003 40151
City
Lublin
Country
Poland
Facility Name
Mg0003 40153
City
Poznań
Country
Poland
Facility Name
Mg0003 40154
City
Łódź
Country
Poland
Facility Name
Mg0003 20168
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Mg0003 20027
City
Moscow
Country
Russian Federation
Facility Name
Mg0003 20169
City
Novosibirsk
Country
Russian Federation
Facility Name
Mg0003 20001
City
Saint Petersburg
Country
Russian Federation
Facility Name
Mg0003 20028
City
Saint Petersburg
Country
Russian Federation
Facility Name
Mg0003 20029
City
Saint Petersburg
Country
Russian Federation
Facility Name
Mg0003 20055
City
Saint Petersburg
Country
Russian Federation
Facility Name
Mg0003 20197
City
Samara
Country
Russian Federation
Facility Name
Mg0003 40468
City
Belgrade
Country
Serbia
Facility Name
Mg0003 40467
City
Niš
Country
Serbia
Facility Name
Mg0003 40159
City
Barcelona
Country
Spain
Facility Name
Mg0003 40160
City
Barcelona
Country
Spain
Facility Name
Mg0003 40267
City
Barcelona
Country
Spain
Facility Name
Mg0003 40157
City
Hospitalet de Llobregat
Country
Spain
Facility Name
Mg0003 40161
City
Madrid
Country
Spain
Facility Name
Mg0003 40162
City
Madrid
Country
Spain
Facility Name
Mg0003 40350
City
Murcia
Country
Spain
Facility Name
Mg0003 40341
City
Málaga
Country
Spain
Facility Name
Mg0003 40308
City
San Sebastián De Los Reyes
Country
Spain
Facility Name
Mg0003 20080
City
Taichung
Country
Taiwan
Facility Name
Mg0003 20081
City
Taipei
Country
Taiwan
Facility Name
Mg0003 20086
City
Taipei
Country
Taiwan
Facility Name
Mg0003 20082
City
Taoyuan
Country
Taiwan
Facility Name
Mg0003 40175
City
London
Country
United Kingdom
Facility Name
Mg0003 40168
City
Nottingham
Country
United Kingdom

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
Citations:
PubMed Identifier
37059507
Citation
Bril V, Druzdz A, Grosskreutz J, Habib AA, Mantegazza R, Sacconi S, Utsugisawa K, Vissing J, Vu T, Boehnlein M, Bozorg A, Gayfieva M, Greve B, Woltering F, Kaminski HJ; MG0003 study team. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol. 2023 May;22(5):383-394. doi: 10.1016/S1474-4422(23)00077-7. Erratum In: Lancet Neurol. 2023 Oct;22(10):e11.
Results Reference
result
PubMed Identifier
33219142
Citation
Bril V, Benatar M, Andersen H, Vissing J, Brock M, Greve B, Kiessling P, Woltering F, Griffin L, Van den Bergh P; MG0002 Investigators. Efficacy and Safety of Rozanolixizumab in Moderate to Severe Generalized Myasthenia Gravis: A Phase 2 Randomized Control Trial. Neurology. 2021 Feb 9;96(6):e853-e865. doi: 10.1212/WNL.0000000000011108. Epub 2020 Nov 20.
Results Reference
derived

Learn more about this trial

A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

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