search
Back to results

Myasthenia Gravis Inebilizumab Trial (MINT)

Primary Purpose

Myasthenia Gravis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
inebilizumab
IV Placebo
Sponsored by
Viela Bio (acquired by Horizon Therapeutics)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myasthenia Gravis focused on measuring Myasthenia Gravis

Eligibility Criteria

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

Inclusion Criteria:

  1. Diagnosis of MG with anti-AChR or anti-MuSK antibody.
  2. MGFA Clinical Classification Class II, III, or IV.
  3. MG-ADL score of 6 or greater at screening and at randomization with > 50% of this score attributed to non-ocular items.
  4. QMG score of 11 or greater.

  5. Subjects must be on:

    1. Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or
    2. One allowed non-steroidal IST, with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization, or
    3. Combination of (1) corticosteroids with no dose increase within 4 weeks prior to randomization and (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.

Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid.

Exclusion Criteria:

  1. Receipt within the 4 weeks prior to Day 1:

    1. Cyclosporine (except eye drops)
    2. Tacrolimus (except topical)
    3. Methotrexate

  2. Current use of:

    1. Prednisone > 40 mg/day or > 80 mg over a 2-day period (or equivalent dose of other corticosteroids)

Sites / Locations

  • Viela Bio Investigative Site - 1010
  • Viela Bio Investigative Site - 1015Recruiting
  • Viela Bio Investigative Site - 1013Recruiting
  • Viela Bio Investigative Site - 1002Recruiting
  • Viela Bio Investigative Center - 1024Recruiting
  • Viela Bio Investigative Site - 1005Recruiting
  • Viela Bio Investigative Site - 1016Recruiting
  • Viela Bio Investigative Site - 1012Recruiting
  • Viela Bio Investigative Site - 1011
  • Viela Bio Investigative Site - 1020
  • Viela Bio Investigative Site - 1007
  • Viela Bio Investigative Site - 1018Recruiting
  • Viela Bio Investigative Site - 1025Recruiting
  • Viela Bio Investigative Site - 1001Recruiting
  • Viela Bio Investigative Site - 1009Recruiting
  • Viela Bio Investigative Site - 1008Recruiting
  • Viela Bio Investigative Site - 1019Recruiting
  • Viela Bio Investigative Site - 1003Recruiting
  • Viela Bio Investigative Site - 1014Recruiting
  • Viela Bio Investigative Site - 1017Recruiting
  • Viela Bio Investigative Site - 1004Recruiting
  • Viela Bio Investigative Site - 1006Recruiting
  • Viela Bio Investigative Site - 2001Recruiting
  • VielaBio Investigative Site - 2002Recruiting
  • Viela Bio Investigative Site - 2003Recruiting
  • Viela Bio Investigative Site - 5203Recruiting
  • Viela Bio Investigative Site - 5202
  • Viela Bio Investigative Site - 5204Recruiting
  • Viela Bio Investigative Site - 5201Recruiting
  • VielaBio Investigative Site - 2201Recruiting
  • VielaBio Investigative Site - 2203Recruiting
  • VielaBio Investigative Site - 2207Recruiting
  • VielaBio Investigative Site - 2206Recruiting
  • Viela Bio Investigative Site - 2205Recruiting
  • Viela Bio Investigative Site - 1102Recruiting
  • Viela Bio Investigative Site - 1101Recruiting
  • Viela Bio Investigative Site - 1103Recruiting
  • Viela Bio Investigative Site - 1104
  • Viela Bio Investigative Site 4009Recruiting
  • Viela Bio Investigative Site - 4007Recruiting
  • Viela Bio Investigative Site 4003Recruiting
  • Viela Bio Investigative Site - 4005Recruiting
  • Viela Bio Investigative site 4010Recruiting
  • Viela Bio Investigative Site - 4011Recruiting
  • Viela Bio Investigative Site - 4006Recruiting
  • Viela Bio Investigative Site - 4008Recruiting
  • Viela Bio Investigative Site - 4004Recruiting
  • Viela Bio Investigative Site 4012Recruiting
  • Viela Bio Investigative Site - 5602
  • Viela Bio Investigative Site - 5601Recruiting
  • Viela Bio Investigative Site - 3003Recruiting
  • Viela Bio Investigative Site - 3001Recruiting
  • Viela Bio Investigative Site - 3002Recruiting
  • VielaBio Investigative Site - 3101Recruiting
  • Viela Bio Investigative Site - 4113Recruiting
  • Viela Bio Investigative Site - 4111
  • Viela Bio Investigative Site - 4112Recruiting
  • Viela Bio Investigative Site - 4104Recruiting
  • Viela Bio investigative Site - 4105Recruiting
  • Viela Bio Investigative Site - 4103Recruiting
  • Viela Bio Investigative Site - 4102Recruiting
  • Viela Bio Investigative Site - 4110
  • Viela Bio Investigative Site - 4108
  • Viela Bio Investigative Site - 4109Recruiting
  • Viela Bio Investigative Site - 4101Recruiting
  • Viela Bio Investigative Site - 5703
  • Viela Bio Investigative Site - 5701
  • Viela Bio Investigative Site - 5702
  • Viela Bio Investigative Site - 3204Recruiting
  • Viela Bio Investigative Site - 3203Recruiting
  • Viela Bio Investigative Site - 3201Recruiting
  • Viela Bio Investigative Site - 3202Recruiting
  • Viela Bio Investigative Site - 4402Recruiting
  • Viela Bio Investigative Site - 4410Recruiting
  • Viela Bio Investigative Site 4409Recruiting
  • Viela Bio Investigative Site - 4401Recruiting
  • VielaBio Investigative Site - 4408Recruiting
  • Viela Bio Investigative Site - 4406Recruiting
  • Viela Bio Investigative Site 4405Recruiting
  • Viela Bio Investigative Site - 4413Recruiting
  • VielaBio Investigative Site - 4407Recruiting
  • Viela Bio Investigative Site - 4404Recruiting
  • VielaBio Investigative Site - 4411
  • Viela Bio Investigative Site - 4202Recruiting
  • Viela Bio Investigative Site - 4203Recruiting
  • Viela Bio Investigative Site - 4201Recruiting
  • Viela Bio Investigative Site - 3306Recruiting
  • Viela Bio Investigative Site - 3302Recruiting
  • Viela Bio Investigative Site - 3303Recruiting
  • Viela Bio Investigative Site - 3301Recruiting
  • Viela Bio Investigative Site - 3305Recruiting
  • Viela Bio Investigative Site - 3310Recruiting
  • Viela Bio Investigative Site - 5303
  • Viela Bio Investigative Site - 5302
  • Viela Bio Investigative Site - 5304
  • Viela Bio Investigative Site - 5311
  • Viela Bio Investigative Site - 5309
  • Viela Bio Investigative Site - 5308
  • Viela Bio Investigative Site - 5305
  • Viela Bio Investigative Site - 5306
  • Viela Bio Investigative Site - 5301
  • Viela Bio Investigative Site - 5312
  • Viela Bio Investigative Site - 3403Recruiting
  • Viela Bio Investigative Site - 3402Recruiting
  • Viela Bio Investigative Site - 3404Recruiting
  • Viela Bio Investigative Site - 3401
  • Viela Bio Investigative Site - 4601
  • Viela Bio investigative Site - 4605Recruiting
  • Viela Bio Investigative Site 4608Recruiting
  • Viela Bio Investigative Site - 4606Recruiting
  • Viela Bio Investigative Site - 4604Recruiting
  • Viela Bio Investigative Site - 4603Recruiting
  • Viela Bio Investigative Site -4607Recruiting
  • Viela Bio Investigative Site - 4602Recruiting
  • Viela Bio Investigative Site - 3903Recruiting
  • Viela Bio Investigative Site - 3901Recruiting
  • Viela Bio Investigative Site - 3902Recruiting
  • Viela Bio Investigative Site - 3905Recruiting
  • Viela Bio Investigative Site - 5103
  • Viela Bio Investigative Site - 5105Recruiting
  • Viela Bio Investigative Site - 5104Recruiting
  • Viela Bio Investigative Site - 5101
  • Viela Bio Investigative Site - 5106

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Inebilizumab, (AChR-Ab+) MG

Placebo, (AChR-Ab+) MG

Inebilizumab, (MuSK-Ab+) MG

Placebo, (MuSK-Ab+) MG

Arm Description

Participants will receive inebilizumab administered intravenously (IV) on Days 1, 15, and 183 of the RCP. Participants who elect to enter the open label phase (OLP) will receive inebilizumab administered IV on OLP Days 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.

Participants will receive placebo administered IV on Days 1, 15, and 183 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.

Participants will receive inebilizumab administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Day 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.

Participants will receive placebo administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.

Outcomes

Primary Outcome Measures

Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score.

Secondary Outcome Measures

Change in Quantitative Myasthenia Gravis (QMG) scores.
Proportion of participants with both ≥ 3-point improvement in MG-ADL and did not initiate rescue therapy.
Change in MG-ADL at Week 26 in the AChR-Ab+ population. (AChR-Ab+ Only)
Time to first exacerbation.
Change in Myasthenia Gravis Composite (MGC) score.
Change in Myasthenia Gravis Quality of Life-15, revised (MGQOL-15r) score.
Change in Patient Global Impression of Change (PGIC) score.
Number of participants with treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and treatment-emergent serious adverse events (TESAEs) during the RCP and OLP.

Full Information

First Posted
August 10, 2020
Last Updated
September 15, 2023
Sponsor
Viela Bio (acquired by Horizon Therapeutics)
search

1. Study Identification

Unique Protocol Identification Number
NCT04524273
Brief Title
Myasthenia Gravis Inebilizumab Trial
Acronym
MINT
Official Title
A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2020 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
March 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viela Bio (acquired by Horizon Therapeutics)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.
Detailed Description
This study is a phase 3, randomized, double-blind, placebo-controlled study, to be conducted at approximately 120 study sites. Approximately 270 participants (188 acetylcholine receptor antibody positive [AChR-Ab+] and 82 muscle-specific tyrosine kinase antibody positive [MuSK-Ab+]) will be enrolled. Participants with Myasthenia Gravis (MG) who are positive for anti-AChR or anti-MuSK antibodies will be enrolled and analyzed separately as 2 populations: (1) AChR-Ab+ and (2) MuSK-Ab+. Patients who do not have anti-AChR or anti-MuSK antibodies will not be enrolled. Patients with Myasthenia Gravis Foundation of America (MGFA) classification II, III, or IV disease, Myasthenia Gravis Activities of Daily Living (MG-ADL) score at screening and randomization between 6 and 10 with > 50% of this score attributed to non-ocular items, or an MG-ADL score >=11, Quantitative Myasthenia Gravis (QMG) score >= 11 at the time of screening and randomization, and use of a corticosteroid and/or non-steroidal immunosuppressant will be included in the study. All subjects who complete the randomized controlled period (RCP) will have the option to enroll in a 3-year (156 weeks) open-label period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis
Keywords
Myasthenia Gravis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study with Open-label Period
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This is a double-blind study in which the IV inebilizumab and the IV placebo are matching in appearance.
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inebilizumab, (AChR-Ab+) MG
Arm Type
Experimental
Arm Description
Participants will receive inebilizumab administered intravenously (IV) on Days 1, 15, and 183 of the RCP. Participants who elect to enter the open label phase (OLP) will receive inebilizumab administered IV on OLP Days 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.
Arm Title
Placebo, (AChR-Ab+) MG
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo administered IV on Days 1, 15, and 183 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.
Arm Title
Inebilizumab, (MuSK-Ab+) MG
Arm Type
Experimental
Arm Description
Participants will receive inebilizumab administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Day 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.
Arm Title
Placebo, (MuSK-Ab+) MG
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.
Intervention Type
Drug
Intervention Name(s)
inebilizumab
Other Intervention Name(s)
MEDI-551, VIB0551
Intervention Description
Participants will receive IV inebilizumab
Intervention Type
Drug
Intervention Name(s)
IV Placebo
Intervention Description
Participants will receive IV placebo matched to inebilizumab
Primary Outcome Measure Information:
Title
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score.
Time Frame
Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population
Secondary Outcome Measure Information:
Title
Change in Quantitative Myasthenia Gravis (QMG) scores.
Time Frame
Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population
Title
Proportion of participants with both ≥ 3-point improvement in MG-ADL and did not initiate rescue therapy.
Time Frame
Between Week 44 and Week 52 for AChR-Ab+ population and Week 22 and Week 26 for MuSK-Ab+ population
Title
Change in MG-ADL at Week 26 in the AChR-Ab+ population. (AChR-Ab+ Only)
Time Frame
Week 26 for AChR-Ab+ population
Title
Time to first exacerbation.
Time Frame
Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population
Title
Change in Myasthenia Gravis Composite (MGC) score.
Time Frame
Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population
Title
Change in Myasthenia Gravis Quality of Life-15, revised (MGQOL-15r) score.
Time Frame
Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population
Title
Change in Patient Global Impression of Change (PGIC) score.
Time Frame
Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population
Title
Number of participants with treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and treatment-emergent serious adverse events (TESAEs) during the RCP and OLP.
Time Frame
Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of MG with anti-AChR or anti-MuSK antibody. MGFA Clinical Classification Class II, III, or IV. MG-ADL score of 6 or greater at screening and at randomization with > 50% of this score attributed to non-ocular items. QMG score of 11 or greater. Participants must be on: Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or One allowed non-steroidal immunosuppressive therapy (IST), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization, or Combination of (1) corticosteroids with no dose increase within 4 weeks prior to randomization and (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization. Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid. Exclusion Criteria: Receipt of the following medications within the 4 weeks prior to Day 1: Cyclosporine (except eye drops) Tacrolimus (except topical) Methotrexate Current use of: Corticosteroids (Prednisone > 40 milligram (mg)/day or > 80 mg over a 2-day period (or equivalent dose of other corticosteroids). Acetylcholinesterase inhibitors (pyridostigmine) > 480 mg/day) or unstable dose in the 2 weeks prior to Day 1. Azathioprine > 3 mg/kilogram (kg)/day Mycophenolate mofetil > 3 grams/day or mycophenolic acid > 1440 mg/day Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Horizon Therapeutics
Phone
1-866-479-6742
Email
clinicaltrials@horizontherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Horizon Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Viela Bio Investigative Site - 1010
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 1015
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1013
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1002
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Center - 1024
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1005
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1016
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1012
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1011
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 1020
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 1007
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 1018
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1025
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1001
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1009
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1008
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1019
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1003
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1014
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1017
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1004
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1006
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 2001
City
Buenos Aires
ZIP/Postal Code
C1023AAB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
VielaBio Investigative Site - 2002
City
Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 2003
City
Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 5203
City
Grodno
ZIP/Postal Code
230030
Country
Belarus
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 5202
City
Minsk
ZIP/Postal Code
220045
Country
Belarus
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 5204
City
Minsk
ZIP/Postal Code
220114
Country
Belarus
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 5201
City
Vitebsk
ZIP/Postal Code
210009
Country
Belarus
Individual Site Status
Recruiting
Facility Name
VielaBio Investigative Site - 2201
City
Porto Alegre
ZIP/Postal Code
90035-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
VielaBio Investigative Site - 2203
City
Porto Alegre
ZIP/Postal Code
90840-440
Country
Brazil
Individual Site Status
Recruiting
Facility Name
VielaBio Investigative Site - 2207
City
Ribeirão Preto
ZIP/Postal Code
14051-140
Country
Brazil
Individual Site Status
Recruiting
Facility Name
VielaBio Investigative Site - 2206
City
San Paolo
ZIP/Postal Code
01228-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 2205
City
São Paulo
ZIP/Postal Code
08270-120
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1102
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1101
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1103
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 1104
City
West Vancouver
ZIP/Postal Code
V7T1C5
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site 4009
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4007
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site 4003
City
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4005
City
Guiyang
ZIP/Postal Code
550004
Country
China
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative site 4010
City
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4011
City
Jinan
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4006
City
Shanghai
ZIP/Postal Code
201107
Country
China
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4008
City
Suzhou
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4004
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site 4012
City
Xi'an
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 5602
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 5601
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3003
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3001
City
Nice Cedex 01
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3002
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Name
VielaBio Investigative Site - 3101
City
Essen
ZIP/Postal Code
45122
Country
Germany
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4113
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4111
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632517
Country
India
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 4112
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500082
Country
India
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4104
City
Bangalore
ZIP/Postal Code
560002
Country
India
Individual Site Status
Recruiting
Facility Name
Viela Bio investigative Site - 4105
City
Lucknow
ZIP/Postal Code
226014
Country
India
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4103
City
Manipala
ZIP/Postal Code
576104
Country
India
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4102
City
Nashik
ZIP/Postal Code
422002
Country
India
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4110
City
Pondicherry
ZIP/Postal Code
605 006
Country
India
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 4108
City
Pune
ZIP/Postal Code
411001
Country
India
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 4109
City
Pune
ZIP/Postal Code
411004
Country
India
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4101
City
Surat
ZIP/Postal Code
395002
Country
India
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 5703
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Viela Bio Investigative Site - 5701
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 5702
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 3204
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3203
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3201
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3202
City
Rome
ZIP/Postal Code
168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4402
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4410
City
Chiba
ZIP/Postal Code
286-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site 4409
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4401
City
Hanamaki
ZIP/Postal Code
025-0082
Country
Japan
Individual Site Status
Recruiting
Facility Name
VielaBio Investigative Site - 4408
City
Hokkaido
ZIP/Postal Code
041-8680
Country
Japan
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4406
City
Hyōgo
ZIP/Postal Code
663-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site 4405
City
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4413
City
Moriguchi
ZIP/Postal Code
570-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
VielaBio Investigative Site - 4407
City
Morioka-shi
ZIP/Postal Code
020-8505
Country
Japan
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4404
City
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
VielaBio Investigative Site - 4411
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 4202
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4203
City
Seoul
ZIP/Postal Code
5030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4201
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3306
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3302
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3303
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3301
City
Kraków
ZIP/Postal Code
31-505
Country
Poland
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3305
City
Nowa Sol
ZIP/Postal Code
67-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3310
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 5303
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Viela Bio Investigative Site - 5302
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Viela Bio Investigative Site - 5304
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Viela Bio Investigative Site - 5311
City
Rostov-on-Don
ZIP/Postal Code
344015
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Viela Bio Investigative Site - 5309
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Viela Bio Investigative Site - 5308
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Viela Bio Investigative Site - 5305
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Viela Bio Investigative Site - 5306
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 5301
City
Tomsk
ZIP/Postal Code
634009
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 5312
City
Ufa
ZIP/Postal Code
450083
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Viela Bio Investigative Site - 3403
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3402
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3404
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3401
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 4601
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Viela Bio investigative Site - 4605
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site 4608
City
New Taipei City
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4606
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4604
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4603
City
Taipei
ZIP/Postal Code
111
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site -4607
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 4602
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3903
City
Ankara
ZIP/Postal Code
6230
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3901
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3902
City
İzmir
ZIP/Postal Code
35330
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 3905
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 5103
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Viela Bio Investigative Site - 5105
City
Ivano-Frankivs'k
ZIP/Postal Code
76493
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 5104
City
Lutsk
ZIP/Postal Code
43005
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Viela Bio Investigative Site - 5101
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Viela Bio Investigative Site - 5106
City
Vinnytsia
ZIP/Postal Code
21050
Country
Ukraine
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

Myasthenia Gravis Inebilizumab Trial

We'll reach out to this number within 24 hrs