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A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

Primary Purpose

Generalized Myasthenia Gravis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rozanolixizumab
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 meet one of the following:

    1. completed MG0003 [NCT03971422]
    2. required rescue therapy during the Observation Period in MG0003 or
    3. completed at least 6 visits in MG0004 [NCT04124965]
  • Body weight ≥35 kg at Baseline (Day 1)
  • Study participants may be male or female

Exclusion Criteria:

  • Study participant has a known hypersensitivity to any components of the study medication or other anti-neonatal Fc receptor (FcRn) medications
  • 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)
  • Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003, or MG0004, or permanently discontinued study drug in either study
  • Study participant intends to have a live vaccination during the course of the study or within 8 weeks following the final 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

  • Mg0007 50092
  • Mg0007 50099
  • Mg0007 50122
  • Mg0007 50120
  • Mg0007 50073
  • Mg0007 50075
  • Mg0007 50323
  • Mg0007 50114
  • Mg0007 50121
  • Mg0007 50077
  • Mg0007 50090
  • Mg0007 50096
  • Mg0007 50113
  • Mg0007 50071
  • Mg0007 50066
  • Mg0007 50124
  • Mg0007 50070
  • Mg0007 50069
  • Mg0007 40125
  • Mg0007 40124
  • Mg0007 40128
  • Mg0007 40127
  • Mg0007 40126
  • Mg0007 40129
  • Mg0007 40360
  • Mg0007 40132
  • Mg0007 40133
  • Mg0007 40131
  • Mg0007 20160
  • Mg0007 20161
  • Mg0007 20163
  • Mg0007 20164
  • Mg0007 20165
  • Mg0007 40134
  • Mg0007 40140
  • Mg0007 40139
  • Mg0007 40078
  • Mg0007 40177
  • Mg0007 40283
  • Mg0007 40144
  • Mg0007 40307
  • Mg0007 40146
  • Mg0007 40148
  • Mg0007 40150
  • Mg0007 20035
  • Mg0007 20068
  • Mg0007 20078
  • Mg0007 20079
  • Mg0007 20075
  • Mg0007 20071
  • Mg0007 20077
  • Mg0007 20070
  • Mg0007 20076
  • Mg0007 20032
  • Mg0007 40155
  • Mg0007 40154
  • Mg0007 40151
  • Mg0007 40153
  • Mg0007 20169
  • Mg0007 20001
  • Mg0007 20028
  • Mg0007 20055
  • Mg0007 40467
  • Mg0007 40160
  • Mg0007 40157
  • Mg0007 40350
  • Mg0007 40308
  • Mg0007 20081
  • Mg0007 20086

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rozanolixizumab dosage regimen 1

Rozanolixizumab dosage regimen 2

Arm Description

Study participants randomized/assigned to dosage regimen 1 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion.

Study participants randomized/assigned to dosage regimen 2 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion.

Outcomes

Primary Outcome Measures

Percentage of participants with treatment-emergent adverse events (TEAEs)
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.
Percentage of participants with TEAEs leading to withdrawal of investigational medicinal product (IMP)
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. AEs leading to permanent withdrawal of study medication.

Secondary Outcome Measures

Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score within one treatment cycle
The Outcome Measure is applicable for the first 3 treatment cycles. The total MG-ADL score is obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3). The score ranges from 0 to 24, with a higher score indicating more disability. A positive change indicates worsening and a negative change indicates improvement.
Change from Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) score within one treatment cycle
The Outcome Measure is applicable for the first 3 treatment cycles. The total QMG score is obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3). The score ranges from 0 to 39, with lower scores indicating lower disease activity.
Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) score within one treatment cycle
The Outcome Measure is applicable for the first 3 treatment cycles. The total MG-C score is obtained by summing the responses to each individual item (10 items; Grade:0-9 depending on item). The score ranges from 0 to 50, with lower scores indicating lower disease activity.
Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' score within one treatment cycle
The Outcome Measure is applicable for the first 3 treatment cycles. The MG symptoms PRO instrument consists of 42 items across 5 scales: ocular symptoms (items 1-5); bulbar symptoms (items 6-15); respiratory symptoms (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). The study participant will be asked to choose the response option that best describes the severity of ocular, bulbar, and respiratory symptoms over the past 7 days using a 4-point Likert scale ("none" to "severe") and how frequently they experience physical fatigue and muscle weakness fatigability over the past 7 days using a 5-point Likert scale ("none of the time" to "all of the time"), respectively.
Change from Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Physical Fatigue' score within one treatment cycle
The Outcome Measure is applicable for the first 3 treatment cycles. The MG symptoms PRO instrument consists of 42 items across 5 scales: ocular symptoms (items 1-5); bulbar symptoms (items 6-15); respiratory symptoms (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). The study participant will be asked to choose the response option that best describes the severity of ocular, bulbar, and respiratory symptoms over the past 7 days using a 4-point Likert scale ("none" to "severe") and how frequently they experience physical fatigue and muscle weakness fatigability over the past 7 days using a 5-point Likert scale ("none of the time" to "all of the time"), respectively.
Change from Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Bulbar symptoms' score within one treatment cycle
The Outcome Measure is applicable for the first 3 treatment cycles. The MG symptoms PRO instrument consists of 42 items across 5 scales: ocular symptoms (items 1-5); bulbar symptoms (items 6-15); respiratory symptoms (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). The study participant will be asked to choose the response option that best describes the severity of ocular, bulbar, and respiratory symptoms over the past 7 days using a 4-point Likert scale ("none" to "severe") and how frequently they experience physical fatigue and muscle weakness fatigability over the past 7 days using a 5-point Likert scale ("none of the time" to "all of the time"), respectively.
MG-ADL responder (≥2.0-point improvement from Baseline [Day 1] to end of Day 43) within one treatment cycle
The Outcome Measure is applicable for the first 3 treatment cycles. A MG-ADL responder is defined as achieving at least 2.0-point improvement in the MG-ADL score from Baseline.
Time to MG-ADL response (≥2.0-point improvement from Baseline [Day 1]) within one treatment cycle
The Outcome Measure is applicable for the first 3 treatment cycles. Time to achieve MG-ADL response, defined as at least 2.0-point improvement from Baseline.
Time between consecutive treatment cycles
Time between consecutive treatment cycles: Study participants will be assessed for MG worsening prior to repeated cycles. In case of symptom worsening (eg, an increase of 2.0 points on the MG-ADL or 3.0 points on the QMG scale) between assessments, resulting in a need for additional treatment, study participants will undergo another 6-week treatment cycle followed by an Observation Period, based on the Investigator's discretion.

Full Information

First Posted
November 5, 2020
Last Updated
October 5, 2023
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT04650854
Brief Title
A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
Official Title
An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 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.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).

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
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rozanolixizumab dosage regimen 1
Arm Type
Experimental
Arm Description
Study participants randomized/assigned to dosage regimen 1 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion.
Arm Title
Rozanolixizumab dosage regimen 2
Arm Type
Experimental
Arm Description
Study participants randomized/assigned to dosage regimen 2 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion.
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.
Primary Outcome Measure Information:
Title
Percentage of participants with treatment-emergent adverse events (TEAEs)
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 Baseline (Day 1) to End of Study (average of 20 months)
Title
Percentage of participants with TEAEs leading to withdrawal of investigational medicinal product (IMP)
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. AEs leading to permanent withdrawal of study medication.
Time Frame
From Baseline (Day 1) to End of Study (average of 20 months)
Secondary Outcome Measure Information:
Title
Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score within one treatment cycle
Description
The Outcome Measure is applicable for the first 3 treatment cycles. The total MG-ADL score is obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3). The score ranges from 0 to 24, with a higher score indicating more disability. A positive change indicates worsening and a negative change indicates improvement.
Time Frame
From Baseline (Day 1) to end of treatment cycle (up to 6 weeks)
Title
Change from Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) score within one treatment cycle
Description
The Outcome Measure is applicable for the first 3 treatment cycles. The total QMG score is obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3). The score ranges from 0 to 39, with lower scores indicating lower disease activity.
Time Frame
From Baseline (Day 1) to end of treatment cycle (up to 6 weeks)
Title
Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) score within one treatment cycle
Description
The Outcome Measure is applicable for the first 3 treatment cycles. The total MG-C score is obtained by summing the responses to each individual item (10 items; Grade:0-9 depending on item). The score ranges from 0 to 50, with lower scores indicating lower disease activity.
Time Frame
From Baseline (Day 1) to end of treatment cycle (up to 6 weeks)
Title
Change from Baseline (Day 1) to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' score within one treatment cycle
Description
The Outcome Measure is applicable for the first 3 treatment cycles. The MG symptoms PRO instrument consists of 42 items across 5 scales: ocular symptoms (items 1-5); bulbar symptoms (items 6-15); respiratory symptoms (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). The study participant will be asked to choose the response option that best describes the severity of ocular, bulbar, and respiratory symptoms over the past 7 days using a 4-point Likert scale ("none" to "severe") and how frequently they experience physical fatigue and muscle weakness fatigability over the past 7 days using a 5-point Likert scale ("none of the time" to "all of the time"), respectively.
Time Frame
From Baseline (Day 1) to end of treatment cycle (up to 6 weeks)
Title
Change from Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Physical Fatigue' score within one treatment cycle
Description
The Outcome Measure is applicable for the first 3 treatment cycles. The MG symptoms PRO instrument consists of 42 items across 5 scales: ocular symptoms (items 1-5); bulbar symptoms (items 6-15); respiratory symptoms (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). The study participant will be asked to choose the response option that best describes the severity of ocular, bulbar, and respiratory symptoms over the past 7 days using a 4-point Likert scale ("none" to "severe") and how frequently they experience physical fatigue and muscle weakness fatigability over the past 7 days using a 5-point Likert scale ("none of the time" to "all of the time"), respectively.
Time Frame
From Baseline (Day 1) to end of treatment cycle (up to 6 weeks)
Title
Change from Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Bulbar symptoms' score within one treatment cycle
Description
The Outcome Measure is applicable for the first 3 treatment cycles. The MG symptoms PRO instrument consists of 42 items across 5 scales: ocular symptoms (items 1-5); bulbar symptoms (items 6-15); respiratory symptoms (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). The study participant will be asked to choose the response option that best describes the severity of ocular, bulbar, and respiratory symptoms over the past 7 days using a 4-point Likert scale ("none" to "severe") and how frequently they experience physical fatigue and muscle weakness fatigability over the past 7 days using a 5-point Likert scale ("none of the time" to "all of the time"), respectively.
Time Frame
From Baseline (Day 1) to end of treatment cycle (up to 6 weeks)
Title
MG-ADL responder (≥2.0-point improvement from Baseline [Day 1] to end of Day 43) within one treatment cycle
Description
The Outcome Measure is applicable for the first 3 treatment cycles. A MG-ADL responder is defined as achieving at least 2.0-point improvement in the MG-ADL score from Baseline.
Time Frame
From Baseline (Day 1) to end of treatment cycle (up to 6 weeks)
Title
Time to MG-ADL response (≥2.0-point improvement from Baseline [Day 1]) within one treatment cycle
Description
The Outcome Measure is applicable for the first 3 treatment cycles. Time to achieve MG-ADL response, defined as at least 2.0-point improvement from Baseline.
Time Frame
From Baseline (Day 1) to end of treatment cycle (up to 6 weeks)
Title
Time between consecutive treatment cycles
Description
Time between consecutive treatment cycles: Study participants will be assessed for MG worsening prior to repeated cycles. In case of symptom worsening (eg, an increase of 2.0 points on the MG-ADL or 3.0 points on the QMG scale) between assessments, resulting in a need for additional treatment, study participants will undergo another 6-week treatment cycle followed by an Observation Period, based on the Investigator's discretion.
Time Frame
From end of the 6-week treatment cycle (Day 43) to the next 6-week treatment cycle (Day 1), assessed up to 2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Study participant must meet one of the following: completed MG0003 [NCT03971422] required rescue therapy during the Observation Period in MG0003 or completed at least 6 visits in MG0004 [NCT04124965] Body weight ≥35 kg at Baseline (Day 1) Study participants may be male or female Exclusion Criteria: Study participant has a known hypersensitivity to any components of the study medication or other anti-neonatal Fc receptor (FcRn) medications 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) Study participant met any mandatory withdrawal or mandatory study drug discontinuation criteria in MG0003, or MG0004, or permanently discontinued study drug in either study Study participant intends to have a live vaccination during the course of the study or within 8 weeks following the final 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 22733 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Mg0007 50092
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Mg0007 50099
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Mg0007 50122
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Mg0007 50120
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Mg0007 50073
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Mg0007 50075
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-0004
Country
United States
Facility Name
Mg0007 50323
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Mg0007 50114
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Mg0007 50121
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
Mg0007 50077
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mg0007 50090
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Mg0007 50096
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Mg0007 50113
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Mg0007 50071
City
Edmonton
Country
Canada
Facility Name
Mg0007 50066
City
Montreal
Country
Canada
Facility Name
Mg0007 50124
City
Montreal
Country
Canada
Facility Name
Mg0007 50070
City
Quebec
Country
Canada
Facility Name
Mg0007 50069
City
Toronto
Country
Canada
Facility Name
Mg0007 40125
City
Ostrava - Poruba
Country
Czechia
Facility Name
Mg0007 40124
City
Praha 2
Country
Czechia
Facility Name
Mg0007 40128
City
Aalborg
Country
Denmark
Facility Name
Mg0007 40127
City
Aarhus
Country
Denmark
Facility Name
Mg0007 40126
City
Copenhagen
Country
Denmark
Facility Name
Mg0007 40129
City
Bordeaux
Country
France
Facility Name
Mg0007 40360
City
Limoges
Country
France
Facility Name
Mg0007 40132
City
Nice Cedex 1
Country
France
Facility Name
Mg0007 40133
City
Paris
Country
France
Facility Name
Mg0007 40131
City
Strasbourg
Country
France
Facility Name
Mg0007 20160
City
Tbilisi
Country
Georgia
Facility Name
Mg0007 20161
City
Tbilisi
Country
Georgia
Facility Name
Mg0007 20163
City
Tbilisi
Country
Georgia
Facility Name
Mg0007 20164
City
Tbilisi
Country
Georgia
Facility Name
Mg0007 20165
City
Tbilisi
Country
Georgia
Facility Name
Mg0007 40134
City
Essen
Country
Germany
Facility Name
Mg0007 40140
City
Göttingen
Country
Germany
Facility Name
Mg0007 40139
City
Jena
Country
Germany
Facility Name
Mg0007 40078
City
Leipzig
Country
Germany
Facility Name
Mg0007 40177
City
Münster
Country
Germany
Facility Name
Mg0007 40283
City
Bologna
Country
Italy
Facility Name
Mg0007 40144
City
Milano
Country
Italy
Facility Name
Mg0007 40307
City
Napoli
Country
Italy
Facility Name
Mg0007 40146
City
Pavia
Country
Italy
Facility Name
Mg0007 40148
City
Roma
Country
Italy
Facility Name
Mg0007 40150
City
Roma
Country
Italy
Facility Name
Mg0007 20035
City
Bunkyo-ku
Country
Japan
Facility Name
Mg0007 20068
City
Chiba-shi
Country
Japan
Facility Name
Mg0007 20078
City
Hanamaki-shi
Country
Japan
Facility Name
Mg0007 20079
City
Hiroshima
Country
Japan
Facility Name
Mg0007 20075
City
Kobe
Country
Japan
Facility Name
Mg0007 20071
City
Nagasaki-shi
Country
Japan
Facility Name
Mg0007 20077
City
Sendai
Country
Japan
Facility Name
Mg0007 20070
City
Shinjuku-ku
Country
Japan
Facility Name
Mg0007 20076
City
Shinjuku-ku
Country
Japan
Facility Name
Mg0007 20032
City
Suita
Country
Japan
Facility Name
Mg0007 40155
City
Gdansk
Country
Poland
Facility Name
Mg0007 40154
City
Lodz
Country
Poland
Facility Name
Mg0007 40151
City
Lublin
Country
Poland
Facility Name
Mg0007 40153
City
Poznan
Country
Poland
Facility Name
Mg0007 20169
City
Novosibirsk
Country
Russian Federation
Facility Name
Mg0007 20001
City
Saint-petersburg
Country
Russian Federation
Facility Name
Mg0007 20028
City
Saint-petersburg
Country
Russian Federation
Facility Name
Mg0007 20055
City
Saint-petersburg
Country
Russian Federation
Facility Name
Mg0007 40467
City
NIS
Country
Serbia
Facility Name
Mg0007 40160
City
Barcelona
Country
Spain
Facility Name
Mg0007 40157
City
Hospitalet de Llobregat
Country
Spain
Facility Name
Mg0007 40350
City
Murcia
Country
Spain
Facility Name
Mg0007 40308
City
San Sebastián de Los Reyes
Country
Spain
Facility Name
Mg0007 20081
City
Taipei
Country
Taiwan
Facility Name
Mg0007 20086
City
Taipei
Country
Taiwan

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
http://www.Vivli.org

Learn more about this trial

A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

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