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Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis (ADAPTsc)

Primary Purpose

Generalized Myasthenia Gravis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
efgartigimod PH20 SC
efgartigimod IV
Sponsored by
argenx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Myasthenia Gravis

Eligibility Criteria

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

Inclusion Criteria:

Bullet list of each inclusion criterium:

  1. Must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  2. At least 18 years of age at the time of signing the informed consent form.

  3. Diagnosed with generalized Myasthenia Gravis (gMG) with confirmed documentation and supported by at least 1 of the following:

    1. History of abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation
    2. History of positive edrophonium chloride test
    3. Demonstrated improvement in Myasthenia Gravis (MG) signs upon treatment with oral acetylcholinesterase (AChE) inhibitors as assessed by the treating physician
  4. Meeting the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, IVa, or IVb

Exclusion Criteria:

Bullet list of each exclusion criterium:

  1. Are pregnant or lactating, or intend to become pregnant during the study or within 90 days after the last dose of Investigational Medicinal Product.

  2. Has any of the following medical conditions:

    1. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening
    2. Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of myasthenia gravis or put the participant at undue risk.

    3. History of malignancy unless deemed cured by adequate treatment with no evidence of reoccurrence for ≥3 years before the first administration of the IMP. Participants with the following cancers can be included at any time:

      • adequately treated basal cell or squamous cell skin cancer
      • carcinoma in situ of the cervix
      • carcinoma in situ of the breast
      • incidental histological findings of prostate cancer (TNM Classification of Malignant Tumors stage T1a or T1b).
    4. Clinical evidence of other significant serious diseases, or the participant has had a recent major surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.

Sites / Locations

  • Investigator site 2 - US0010032
  • Investigator Site 41 - US0010004
  • Investigator site 2 - US0010108
  • Investigator site 1 - US0010110
  • Investigator Site 27 - US0010006
  • Investigator Site 47 - US0010113
  • Investigator Site 42 - US0010015
  • Investigator Site 11 - US0010111
  • Investigator Site 40 - US0010003
  • Investigator Site 38 - US0010077
  • Investigator Site 43 - 0010019
  • Investigator site 4 - US0010008
  • Investigator Site 28 - US0010066
  • Investigator Site 46 - US0010009
  • Investigator site 5 - BE0320007
  • Investigator site 13 - GE9950002
  • Investigator site 12 - GE9950001
  • Investigator site 14 - GE9950003
  • Investigator Site 44 - GE9950004
  • Investigator Site 45 - GE9950016
  • Investigator Site 30 - DE490006
  • Investigator Site 29 - DE490009
  • Investigator site 15 - HU0360013
  • Investigator Site 16 - HU0360020
  • Investigator Site 17 - IT0390003
  • Investigator Site 39 - IT0390008
  • Investigator Site 31 - JP0810055
  • Investigator Site 18 - JP0810002
  • Investigator site 6 - JPN0810004
  • Investigator Site 33 - JP0810058
  • Investigator Site 19 - JP0810007
  • Investigator Site 34 - JP0810005
  • Investigator Site 32 - JP0810059
  • Investigator Site 20 - JP0810009
  • Investigator Site 7 - NL0310001
  • Investigator Site 21 - PL0480001
  • Investigator Site 8 - PL0480007
  • Investigator Site 9 - PL0480024
  • Investigator Site 22 - PL0480005
  • Investigator Site 23 - PL0480018
  • Investigator Site 24 - PL0480022
  • Investigator Site 35 - RU0070002
  • Investigator Site 36 - RU0070014
  • Investigator Site 37 - ES0340021
  • Investigator Site 26 - ES0340038
  • Investigator Site 25 - ES0340002
  • Investigator Site 10 - ES0340039

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

efgartigimod PH20 SC

efgartigimod

Arm Description

Patients receiving efgartigimod PH20 subcutaneous (SC) treatment

Patients receiving efgartigimod intravenous (IV) treatment

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set)
ANCOVA Analysis of Percent Change From Baseline in Total IgG Level at Day 29 (ie, 7 days after the fourth IV or SC administration).

Secondary Outcome Measures

Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set)
Total IgG level percent change from baseline over time for the overall population.
Percent Change From Baseline in AChR-Ab Levels Over Time in AChR- Ab Positive Patients (mITT Analysis Set)
Percent reduction from baseline in AChR-Ab levels over time in AChR-Ab positive patients measured in mITT Analysis Set. Descriptive statistics have been used for this secondary end point.
Percent Change From Baseline in IgG Subtype Levels Over Time (mITT Analysis Set)
Median (IQR) Percent Change From Baseline for the IgG Subtypes (IgG1, IgG2, IgG3, and IgG4) in the Overall Population. The highest number of patients among all weeks for the analysis is chosen for each arm. Descriptive statistics have been used for this secondary end point.
AUEC of the Percent Change From Baseline in Total IgG Level (mITT Analysis Set)
AUEC of the percent reduction from baseline total IgG per dosing interval (days 1-8, days 8-15, days 15-22, and days 22-29), days 1-29, days 1-57 and over the entire study (days 1-71). The highest number of patients among all weeks for the analysis is chosen for each arm. Descriptive statistics have been used for this secondary end point.
Еfgartigimod IV and PH20 SC Serum Pharmacokinetic Parameter Ctrough
Evaluation of observed predose concentration (Ctrough) (after all doses for the IV and SC treatment arms). The analysis will present data from Week 1 to Week 4. Descriptive statistics have been used for this secondary end point.
Efgartigimod IV Serum Pharmacokinetic Parameter Cmax
Evaluation of maximum observed concentration (Cmax) (after all doses for the IV treatment arm). The analysis will present data from Baseline to Week 3. Descriptive statistics have been used for this secondary end point.
Incidence of ADA Against Efgartigimod (Safety Analysis Set)
Incidence of antidrug antibodies (ADA) against Efgartigimod in the overall population. ADA analysis is performed with a validated ELISA in a 3-tiered approach (ADA screening analysis, confirmatory analysis and a titration assay). Descriptive statistics have been used for this secondary end point.
Incidence of Antibodies Against rHuPH20 in the SC Treatment Arm (Safety Analysis Set)
Incidence of antibodies against rHuPH20 in the Efgartigimod PH20 SC Arm. antibody analysis is performed with a validated ELISA in a 3-tiered approach (screening analysis, confirmatory analysis and a titration assay) Descriptive statistics have been used for this secondary end point.
Incidence and Severity of AEs and SAEs (Safety Analysis Set)
Evaluation of incidence and severity of treatment-emergent adverse events (TEAEs) and incidence of serious AEs (SAEs). Descriptive statistics have been used for this secondary end point.
MG-ADL Responders (ITT Analysis Set)
Evaluation of number and percentage of Myasthenia Gravis Activities of Daily Living (MG-ADL) responders in the overall population. The MG-ADL is an 8-item patient-reported scale that assesses MG symptoms and their effects on daily activities. It evaluates a participant's capacity to perform different activities in their daily life, including talking, chewing, swallowing, breathing, brushing their teeth, combing their hair, or getting up from a chair. The MG-ADL also assesses double vision and eyelid droop. It is a discrete quantitative variable in which the 8 items are rated by the participant on a scale of 0 to 3. The total score can range from 0 to 24, with higher total scores indicating more impairment. A participant was considered a MG-ADL responder if he/she showed a reduction of at least 2 points from baseline on the MG-ADL score for at least 4 consecutive weeks. Descriptive statistics have been used for this secondary end point.
QMG Responders (ITT Analysis Set)
Evaluation of number and percentage of Quantitative Myasthenia Gravis (QMG) responders in the overall population (ITT Analysis Set). Descriptive statistics have been used for this secondary end point. One subject in the EFG IV arm had no post-baseline QMG assessment and thus was excluded from the denominator.
Change From Baseline in MG-ADL Total Score Over Time (ITT Analysis Set)
Evaluation of MG-ADL Total Score Change from baseline over time for the overall population (ITT Analysis Set). Descriptive statistics have been used for this secondary end point. The MG-ADL is an 8-item patient-reported scale that assesses MG symptoms and their effects on daily activities. It evaluates a participant's capacity to perform different activities in their daily life, including talking, chewing, swallowing, breathing, brushing their teeth, combing their hair, or getting up from a chair. The MG-ADL also assesses double vision and eyelid droop. It is a discrete quantitative variable in which the 8 items are rated by the participant on a scale of 0 to 3. The total score can range from 0 to 24, with higher total scores indicating more impairment. A participant was considered a MG-ADL responder if he/she showed a reduction of at least 2 points from baseline on the MG-ADL score for at least 4 consecutive weeks.
Change From Baseline in QMG Score Over Time (ITT Analysis Set)
Evaluation of QMG Total Score change from baseline over time for the overall population (ITT Analysis Set). The QMG (Quantitative Myasthenia Gravis) quantifies disease severity based on impairments of body function and structures as defined by the International Classification of Functioning, Disability and Health. The QMG consists of 13 items that assess ocular, bulbar, and limb function. Six of the 13 items are timed endurance tests measured in seconds. Each item has a possible score from 0 to 3. The total possible score is 39, where higher total scores indicate more severe impairments. It is based on qualitative testing of specific muscle groups to assess limb function. Descriptive statistics have been used for this secondary end point. A participant was considered a QMG responder if he/she showed a reduction of at least 3 points from baseline on the QMG score for at least 4 consecutive weeks.

Full Information

First Posted
January 26, 2021
Last Updated
January 31, 2023
Sponsor
argenx
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1. Study Identification

Unique Protocol Identification Number
NCT04735432
Brief Title
Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
Acronym
ADAPTsc
Official Title
A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC With Multiple Intravenous Infusions of Efgartigimod in Patients With Generalized Myasthenia Gravis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 5, 2021 (Actual)
Primary Completion Date
November 2, 2021 (Actual)
Study Completion Date
December 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
argenx

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20) as compared to efgartigimod IV infused in patients with generalized myasthenia gravis (gMG). The study duration is approximately 12 weeks. After screening, patients will be randomized to receive either efgartigimod infusions or efgartigimod PH20 subcutaneously (SC)
Detailed Description
Main objective of the trial: To demonstrate that the pharmacodynamic (PD) effect of injections of 1000 mg efgartigimod PH20 SC (efgartigimod co-formulated with recombinant humanhyaluronidase PH20 for subcutaneous administration), administered once weekly for 4 administrations, is NI (noninferior) to IV infusions of efgartigimod (efgartigimod formulation for intravenous infusion) at a dose of 10 mg/kg administered once weekly for 4 administrations. Secondary objectives: To compare the PD effect of efgartigimod PH20 SC and efgartigimod IV over time; To evaluate the pharmacokinetics (PK) of efgartigimod PH20 SC and efgartigimod IV; To evaluate the safety, tolerability, and immunogenicity of efgartigimod PH20 SC and efgartigimod IV; To evaluate the clinical efficacy of efgartigimod PH20 SC and efgartigimod IV.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
efgartigimod PH20 SC
Arm Type
Experimental
Arm Description
Patients receiving efgartigimod PH20 subcutaneous (SC) treatment
Arm Title
efgartigimod
Arm Type
Experimental
Arm Description
Patients receiving efgartigimod intravenous (IV) treatment
Intervention Type
Biological
Intervention Name(s)
efgartigimod PH20 SC
Intervention Description
Subcutaneous injection with efgartigimod PH20 SC
Intervention Type
Biological
Intervention Name(s)
efgartigimod IV
Intervention Description
Intravenous infusion of efgartigimod
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set)
Description
ANCOVA Analysis of Percent Change From Baseline in Total IgG Level at Day 29 (ie, 7 days after the fourth IV or SC administration).
Time Frame
From week 0 to week 4
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Total IgG Levels Over Time (mITT Analysis Set)
Description
Total IgG level percent change from baseline over time for the overall population.
Time Frame
From baseline to week 10
Title
Percent Change From Baseline in AChR-Ab Levels Over Time in AChR- Ab Positive Patients (mITT Analysis Set)
Description
Percent reduction from baseline in AChR-Ab levels over time in AChR-Ab positive patients measured in mITT Analysis Set. Descriptive statistics have been used for this secondary end point.
Time Frame
From baseline to week 10
Title
Percent Change From Baseline in IgG Subtype Levels Over Time (mITT Analysis Set)
Description
Median (IQR) Percent Change From Baseline for the IgG Subtypes (IgG1, IgG2, IgG3, and IgG4) in the Overall Population. The highest number of patients among all weeks for the analysis is chosen for each arm. Descriptive statistics have been used for this secondary end point.
Time Frame
Baseline to week 10
Title
AUEC of the Percent Change From Baseline in Total IgG Level (mITT Analysis Set)
Description
AUEC of the percent reduction from baseline total IgG per dosing interval (days 1-8, days 8-15, days 15-22, and days 22-29), days 1-29, days 1-57 and over the entire study (days 1-71). The highest number of patients among all weeks for the analysis is chosen for each arm. Descriptive statistics have been used for this secondary end point.
Time Frame
From baseline to week 10
Title
Еfgartigimod IV and PH20 SC Serum Pharmacokinetic Parameter Ctrough
Description
Evaluation of observed predose concentration (Ctrough) (after all doses for the IV and SC treatment arms). The analysis will present data from Week 1 to Week 4. Descriptive statistics have been used for this secondary end point.
Time Frame
From Week 1 to Week 4.
Title
Efgartigimod IV Serum Pharmacokinetic Parameter Cmax
Description
Evaluation of maximum observed concentration (Cmax) (after all doses for the IV treatment arm). The analysis will present data from Baseline to Week 3. Descriptive statistics have been used for this secondary end point.
Time Frame
From Baseline to Week 3
Title
Incidence of ADA Against Efgartigimod (Safety Analysis Set)
Description
Incidence of antidrug antibodies (ADA) against Efgartigimod in the overall population. ADA analysis is performed with a validated ELISA in a 3-tiered approach (ADA screening analysis, confirmatory analysis and a titration assay). Descriptive statistics have been used for this secondary end point.
Time Frame
From baseline to week 10
Title
Incidence of Antibodies Against rHuPH20 in the SC Treatment Arm (Safety Analysis Set)
Description
Incidence of antibodies against rHuPH20 in the Efgartigimod PH20 SC Arm. antibody analysis is performed with a validated ELISA in a 3-tiered approach (screening analysis, confirmatory analysis and a titration assay) Descriptive statistics have been used for this secondary end point.
Time Frame
From baseline to week 10
Title
Incidence and Severity of AEs and SAEs (Safety Analysis Set)
Description
Evaluation of incidence and severity of treatment-emergent adverse events (TEAEs) and incidence of serious AEs (SAEs). Descriptive statistics have been used for this secondary end point.
Time Frame
From baseline to week 10
Title
MG-ADL Responders (ITT Analysis Set)
Description
Evaluation of number and percentage of Myasthenia Gravis Activities of Daily Living (MG-ADL) responders in the overall population. The MG-ADL is an 8-item patient-reported scale that assesses MG symptoms and their effects on daily activities. It evaluates a participant's capacity to perform different activities in their daily life, including talking, chewing, swallowing, breathing, brushing their teeth, combing their hair, or getting up from a chair. The MG-ADL also assesses double vision and eyelid droop. It is a discrete quantitative variable in which the 8 items are rated by the participant on a scale of 0 to 3. The total score can range from 0 to 24, with higher total scores indicating more impairment. A participant was considered a MG-ADL responder if he/she showed a reduction of at least 2 points from baseline on the MG-ADL score for at least 4 consecutive weeks. Descriptive statistics have been used for this secondary end point.
Time Frame
From baseline to week 10
Title
QMG Responders (ITT Analysis Set)
Description
Evaluation of number and percentage of Quantitative Myasthenia Gravis (QMG) responders in the overall population (ITT Analysis Set). Descriptive statistics have been used for this secondary end point. One subject in the EFG IV arm had no post-baseline QMG assessment and thus was excluded from the denominator.
Time Frame
From Baseline to Week 10
Title
Change From Baseline in MG-ADL Total Score Over Time (ITT Analysis Set)
Description
Evaluation of MG-ADL Total Score Change from baseline over time for the overall population (ITT Analysis Set). Descriptive statistics have been used for this secondary end point. The MG-ADL is an 8-item patient-reported scale that assesses MG symptoms and their effects on daily activities. It evaluates a participant's capacity to perform different activities in their daily life, including talking, chewing, swallowing, breathing, brushing their teeth, combing their hair, or getting up from a chair. The MG-ADL also assesses double vision and eyelid droop. It is a discrete quantitative variable in which the 8 items are rated by the participant on a scale of 0 to 3. The total score can range from 0 to 24, with higher total scores indicating more impairment. A participant was considered a MG-ADL responder if he/she showed a reduction of at least 2 points from baseline on the MG-ADL score for at least 4 consecutive weeks.
Time Frame
From baseline to week 10
Title
Change From Baseline in QMG Score Over Time (ITT Analysis Set)
Description
Evaluation of QMG Total Score change from baseline over time for the overall population (ITT Analysis Set). The QMG (Quantitative Myasthenia Gravis) quantifies disease severity based on impairments of body function and structures as defined by the International Classification of Functioning, Disability and Health. The QMG consists of 13 items that assess ocular, bulbar, and limb function. Six of the 13 items are timed endurance tests measured in seconds. Each item has a possible score from 0 to 3. The total possible score is 39, where higher total scores indicate more severe impairments. It is based on qualitative testing of specific muscle groups to assess limb function. Descriptive statistics have been used for this secondary end point. A participant was considered a QMG responder if he/she showed a reduction of at least 3 points from baseline on the QMG score for at least 4 consecutive weeks.
Time Frame
From baseline to week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Bullet list of each inclusion criterium: Must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. At least 18 years of age at the time of signing the informed consent form. Diagnosed with generalized Myasthenia Gravis (gMG) with confirmed documentation and supported by at least 1 of the following: History of abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation History of positive edrophonium chloride test Demonstrated improvement in Myasthenia Gravis (MG) signs upon treatment with oral acetylcholinesterase (AChE) inhibitors as assessed by the treating physician Meeting the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, IVa, or IVb Exclusion Criteria: Bullet list of each exclusion criterium: Are pregnant or lactating, or intend to become pregnant during the study or within 90 days after the last dose of Investigational Medicinal Product. Has any of the following medical conditions: Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of myasthenia gravis or put the participant at undue risk. History of malignancy unless deemed cured by adequate treatment with no evidence of reoccurrence for ≥3 years before the first administration of the IMP. Participants with the following cancers can be included at any time: adequately treated basal cell or squamous cell skin cancer carcinoma in situ of the cervix carcinoma in situ of the breast incidental histological findings of prostate cancer (TNM Classification of Malignant Tumors stage T1a or T1b). Clinical evidence of other significant serious diseases, or the participant has had a recent major surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.
Facility Information:
Facility Name
Investigator site 2 - US0010032
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
Investigator Site 41 - US0010004
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Investigator site 2 - US0010108
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Investigator site 1 - US0010110
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Investigator Site 27 - US0010006
City
Tampa
State/Province
Florida
ZIP/Postal Code
41076
Country
United States
Facility Name
Investigator Site 47 - US0010113
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Investigator Site 42 - US0010015
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Investigator Site 11 - US0010111
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Investigator Site 40 - US0010003
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Investigator Site 38 - US0010077
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Investigator Site 43 - 0010019
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Investigator site 4 - US0010008
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Investigator Site 28 - US0010066
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Investigator Site 46 - US0010009
City
Texas City
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigator site 5 - BE0320007
City
Gent
State/Province
East-Flanders
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Investigator site 13 - GE9950002
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Investigator site 12 - GE9950001
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Facility Name
Investigator site 14 - GE9950003
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Facility Name
Investigator Site 44 - GE9950004
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Investigator Site 45 - GE9950016
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Investigator Site 30 - DE490006
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Investigator Site 29 - DE490009
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Investigator site 15 - HU0360013
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Investigator Site 16 - HU0360020
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Investigator Site 17 - IT0390003
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Investigator Site 39 - IT0390008
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Investigator Site 31 - JP0810055
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
063-0005
Country
Japan
Facility Name
Investigator Site 18 - JP0810002
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Investigator site 6 - JPN0810004
City
Hanamaki
ZIP/Postal Code
025-0082
Country
Japan
Facility Name
Investigator Site 33 - JP0810058
City
Hiroshima
ZIP/Postal Code
0810058
Country
Japan
Facility Name
Investigator Site 19 - JP0810007
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Investigator Site 34 - JP0810005
City
Sendai
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Investigator Site 32 - JP0810059
City
Tokyo
ZIP/Postal Code
143-8541
Country
Japan
Facility Name
Investigator Site 20 - JP0810009
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Investigator Site 7 - NL0310001
City
Leiden
ZIP/Postal Code
2333
Country
Netherlands
Facility Name
Investigator Site 21 - PL0480001
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Investigator Site 8 - PL0480007
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
Investigator Site 9 - PL0480024
City
Kraków
ZIP/Postal Code
31-2002
Country
Poland
Facility Name
Investigator Site 22 - PL0480005
City
Kraków
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Investigator Site 23 - PL0480018
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Investigator Site 24 - PL0480022
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Investigator Site 35 - RU0070002
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Investigator Site 36 - RU0070014
City
Saint Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Investigator Site 37 - ES0340021
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigator Site 26 - ES0340038
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Investigator Site 25 - ES0340002
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Investigator Site 10 - ES0340039
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis

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