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Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis

Primary Purpose

Generalized Myasthenia Gravis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Batoclimab 680 mg SC weekly
Batoclimab 340 mg SC weekly
Matching Placebo SC
Batoclimab 340 mg SC bi-weekly
Sponsored by
Immunovant Sciences GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Myasthenia Gravis focused on measuring monoclonal antibody, batoclimab, IMVT-1401, Myasthenia Gravis, acetylcholine receptor, RVT-1401

Eligibility Criteria

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

Inclusion Criteria:

  1. Are ≥ 18 years of age at the Screening Visit.
  2. Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit.
  3. Have a QMG score ≥ 11 at the Screening and Baseline Visits.
  4. Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits.
  5. Additional inclusion criteria are defined in the protocol.

Exclusion Criteria:

  1. Have experienced myasthenic crisis within 3 months of the Screening Visit.
  2. Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study period.
  3. Have any active or untreated malignant thymoma.
  4. Have received any agent or therapy (exclusive of those identified within inclusion criteria) with immunosuppressive properties (e.g., stem cell therapy, chemotherapies, etc.) within the past year.
  5. Have used anti-FcRN treatment within 6 months prior to the Screening Visit or have a documented history of non-response to prior anti-FcRN treatment.
  6. Additional exclusion criteria are defined in the protocol.

Sites / Locations

  • Site Number -1022Recruiting
  • Site Number -1002Recruiting
  • Site Number -1009Recruiting
  • Site Number - 1027Recruiting
  • Site Number - 1025Recruiting
  • Site Number -1017Recruiting
  • Site Number -1007Recruiting
  • Site Number -1010Recruiting
  • Site Number -1019Recruiting
  • Site Number - 1028Recruiting
  • Site Number - 1015Recruiting
  • Site Number -1011Recruiting
  • Site Number -1003Recruiting
  • Site Number -1013Recruiting
  • Site Number - 1018Recruiting
  • Site Number -1004Recruiting
  • Site Number -1006Recruiting
  • Site Number - 1023Recruiting
  • Site Number - 1030Recruiting
  • Site Number -1001Recruiting
  • Site Number -1016Recruiting
  • Site Number - 1014Recruiting
  • Site Number -1005Recruiting
  • Site Number -2001Recruiting
  • Site Number -8002Recruiting
  • Site Number -8004Recruiting
  • Site Number -8001Recruiting
  • Site Number -8003Recruiting
  • Site Number - 8005Recruiting
  • Site Number -7553Recruiting
  • Site Number - 7552Recruiting
  • Site Number -6006Recruiting
  • Site Number - 6002Recruiting
  • Site Number - 6003Recruiting
  • Site Number -6001Recruiting
  • Site Number -6005Recruiting
  • Site Number - 4002Recruiting
  • Site Number - 4006Recruiting
  • Site Number - 4009Recruiting
  • Site Number - 4012Recruiting
  • Site Number - 4007Recruiting
  • Site Number - 4011Recruiting
  • Site Number - 4003Recruiting
  • Site Number - 4010Recruiting
  • Site Number - 4004Recruiting
  • Site Number - 4001Recruiting
  • Site Number - 4005Recruiting
  • Site Number -4505Recruiting
  • Site Number -4501Recruiting
  • Site Number -3001Recruiting
  • Site Number -3004Recruiting
  • Site Number - 3003Recruiting
  • Site Number -3002Recruiting
  • Site Number - 3008Recruiting
  • Site Number -3006Recruiting
  • Site Number - 3005Recruiting
  • Site Number -7502Recruiting
  • Site Number -7501Recruiting
  • Site Number -7503Recruiting
  • Site Number - 9001Recruiting
  • Site Number - 9002Recruiting
  • Site Number -3502Recruiting
  • Site Number -3504Recruiting
  • Site Number -3501Recruiting
  • Site Number -3503Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

Batoclimab Induction Dose 1 (Period 1)

Batoclimab Induction Dose 2 (Period 1)

Placebo Induction Dose (Period 1)

Batoclimab Maintenance Dose 1 (Period 2)

Batoclimab Maintenance Dose 2 (Period 2)

Placebo Maintenance Dose (Period 2)

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in acetylcholine receptor (AChR) Ab seropositive (AChRAb+) participants
MG-ADL is an 8-item, participant-reported questionnaire that assesses gMG symptoms and their effects on activities of daily living. Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. Total score ranges from 0 to 24, with higher scores indicating greater functional impairment and disability.

Secondary Outcome Measures

Change from Baseline in Quantitative Myasthenia Gravis (QMG) score in AChRAb+ participants
QMG is clinician-reported assessment to evaluate muscle weakness in participants with MG. The QMG consists of 13 items ranging from 0 to 3 with 3 being the most severe. Total score ranges from 0 to 39, with higher scores representing greater impairment.
Change from Baseline in MG-ADL score for AChRAb+ randomized withdrawal participants
Percentage of AChRAb+ participants with greater than equal to (>=) 3-point improvement in QMG score
Percentage of AChRAb+ participants achieving MG-ADL score of 0 or 1 by Week 12
Change from Baseline in MG-ADL score in AChRAB- (AChRAB negative) participants
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant who has either been administered a study drug or has undergone study procedures.
Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements
Vital signs, including systolic and diastolic blood pressures, pulse rate, respiratory rate, and temperature will be obtained and recorded at specified timepoints. All vital sign measures will be obtained with the participant in the supine position and having rested for at least 5 minutes.
Number of Participants with Clinically Significant Changes in Laboratory Results
Blood samples will be collected at specified timepoints for the analysis of laboratory parameters including clinical chemistry, hematology and urinalysis.
Percentage of participants with clinical laboratory-related TEAEs or treatment emergent laboratory abnormalities.

Full Information

First Posted
May 26, 2022
Last Updated
October 11, 2023
Sponsor
Immunovant Sciences GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05403541
Brief Title
Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
Official Title
A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis (gMG)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunovant Sciences GmbH

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
The purpose of this 3-period study is to confirm the efficacy and safety of batoclimab in participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams (mg) subcutaneously (SC) once a week (QW) or 340 mg SC QW or placebo. The primary efficacy endpoint will be assessed by change in the myasthenia gravis activities of daily living (MG- ADL) score in acetylcholine receptor antibody seropositive (AChRAb+) participants. In Period 2, participants previously treated with batoclimab will be re-randomized to stay on batoclimab (340 mg SC QW or 340 mg SC every two weeks) or receive placebo treatment. The secondary endpoint of maintenance of efficacy will be assessed by change in the MG- ADL score in AChRAb+ participants. Participants demonstrating a response to batoclimab during either Period 1 or 2 may enter the long-term extension (Period 3).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Myasthenia Gravis
Keywords
monoclonal antibody, batoclimab, IMVT-1401, Myasthenia Gravis, acetylcholine receptor, RVT-1401

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Sponsor Staff is also masked, so the study is Quadruple-blind.
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Batoclimab Induction Dose 1 (Period 1)
Arm Type
Experimental
Arm Title
Batoclimab Induction Dose 2 (Period 1)
Arm Type
Experimental
Arm Title
Placebo Induction Dose (Period 1)
Arm Type
Placebo Comparator
Arm Title
Batoclimab Maintenance Dose 1 (Period 2)
Arm Type
Experimental
Arm Title
Batoclimab Maintenance Dose 2 (Period 2)
Arm Type
Experimental
Arm Title
Placebo Maintenance Dose (Period 2)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Batoclimab 680 mg SC weekly
Other Intervention Name(s)
IMVT-1401
Intervention Description
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Batoclimab 340 mg SC weekly
Other Intervention Name(s)
IMVT-1401
Intervention Description
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Matching Placebo SC
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Batoclimab 340 mg SC bi-weekly
Other Intervention Name(s)
IMVT-1401
Intervention Description
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Primary Outcome Measure Information:
Title
Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in acetylcholine receptor (AChR) Ab seropositive (AChRAb+) participants
Description
MG-ADL is an 8-item, participant-reported questionnaire that assesses gMG symptoms and their effects on activities of daily living. Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. Total score ranges from 0 to 24, with higher scores indicating greater functional impairment and disability.
Time Frame
Baseline (Day 1) to Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline in Quantitative Myasthenia Gravis (QMG) score in AChRAb+ participants
Description
QMG is clinician-reported assessment to evaluate muscle weakness in participants with MG. The QMG consists of 13 items ranging from 0 to 3 with 3 being the most severe. Total score ranges from 0 to 39, with higher scores representing greater impairment.
Time Frame
Baseline (Day 1) to Week 12
Title
Change from Baseline in MG-ADL score for AChRAb+ randomized withdrawal participants
Time Frame
Baseline (Week 12) to Week 24
Title
Percentage of AChRAb+ participants with greater than equal to (>=) 3-point improvement in QMG score
Time Frame
Up to Week 12
Title
Percentage of AChRAb+ participants achieving MG-ADL score of 0 or 1 by Week 12
Time Frame
Up to Week 12
Title
Change from Baseline in MG-ADL score in AChRAB- (AChRAB negative) participants
Time Frame
Baseline (Day 1) to Week 12
Title
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Description
An adverse event (AE) is defined as any untoward medical occurrence in a participant who has either been administered a study drug or has undergone study procedures.
Time Frame
Up to 76 Weeks
Title
Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements
Description
Vital signs, including systolic and diastolic blood pressures, pulse rate, respiratory rate, and temperature will be obtained and recorded at specified timepoints. All vital sign measures will be obtained with the participant in the supine position and having rested for at least 5 minutes.
Time Frame
Up to 76 Weeks
Title
Number of Participants with Clinically Significant Changes in Laboratory Results
Description
Blood samples will be collected at specified timepoints for the analysis of laboratory parameters including clinical chemistry, hematology and urinalysis.
Time Frame
Up to 76 Weeks
Title
Percentage of participants with clinical laboratory-related TEAEs or treatment emergent laboratory abnormalities.
Time Frame
Up to 76 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are ≥ 18 years of age at the Screening Visit. Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit. Have a QMG score ≥ 11 at the Screening and Baseline Visits. Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits. Additional inclusion criteria are defined in the protocol. Exclusion Criteria: Have experienced myasthenic crisis within 3 months of the Screening Visit. Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study period. Have any active or untreated malignant thymoma. Have received any agent or therapy (exclusive of those identified within inclusion criteria) with immunosuppressive properties (e.g., stem cell therapy, chemotherapies, etc.) within the past year. Have used anti-FcRN treatment within 3 months prior to the Screening Visit or have a documented history of non-response to prior anti-FcRN treatment. Additional exclusion criteria are defined in the protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Central Study Contact
Phone
18007970414
Email
clinicaltrials@immunovant.com
Facility Information:
Facility Name
Site Number -1022
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number -1002
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number -1009
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number - 1027
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number - 1025
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number -1017
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number -1007
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number -1010
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number -1019
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number - 1028
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number - 1015
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number -1011
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number -1003
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number -1013
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number - 1018
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number -1004
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number -1006
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number - 1023
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number - 1030
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number -1001
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number -1016
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number - 1014
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number -1005
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Name
Site Number -2001
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Site Number -8002
City
Tbilisi
ZIP/Postal Code
00114
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Site Number -8004
City
Tbilisi
ZIP/Postal Code
00114
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Site Number -8001
City
Tbilisi
ZIP/Postal Code
00160
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Site Number -8003
City
Tbilisi
ZIP/Postal Code
00186
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Site Number - 8005
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Site Number -7553
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Site Number - 7552
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Site Number -6006
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site Number - 6002
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site Number - 6003
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site Number -6001
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site Number -6005
City
Roma
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Name
Site Number - 4002
City
Hanamaki-shi
ZIP/Postal Code
025-0082
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site Number - 4006
City
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site Number - 4009
City
Kawasaki-shi
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site Number - 4012
City
Koriyama-shi
ZIP/Postal Code
963-8563
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site Number - 4007
City
Koshigaya-shi
ZIP/Postal Code
343-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site Number - 4011
City
Matsuyama-shi
ZIP/Postal Code
791-8026
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site Number - 4003
City
Narita-shi
ZIP/Postal Code
286-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site Number - 4010
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site Number - 4004
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site Number - 4001
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site Number - 4005
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Site Number -4505
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Site Number -4501
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Site Number -3001
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site Number -3004
City
Krakow
ZIP/Postal Code
31-324
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site Number - 3003
City
Krakow
ZIP/Postal Code
31-503
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site Number -3002
City
Kraków
ZIP/Postal Code
31-505
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site Number - 3008
City
Lublin
ZIP/Postal Code
20-701
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site Number -3006
City
Poznań
ZIP/Postal Code
61-731
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site Number - 3005
City
Warszawa
ZIP/Postal Code
01-684
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site Number -7502
City
Constanta
ZIP/Postal Code
900628
Country
Romania
Individual Site Status
Recruiting
Facility Name
Site Number -7501
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Individual Site Status
Recruiting
Facility Name
Site Number -7503
City
Timişoara
ZIP/Postal Code
300723
Country
Romania
Individual Site Status
Recruiting
Facility Name
Site Number - 9001
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Site Number - 9002
City
Niš
ZIP/Postal Code
1800
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Site Number -3502
City
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site Number -3504
City
Cordoba
ZIP/Postal Code
14011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site Number -3501
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site Number -3503
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis

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