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Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis

Primary Purpose

Generalized Myasthenia Gravis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
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

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ability of the participant and/or his/her legally authorized representative to understand the requirements of the trial and provide written informed consent/assent, if applicable (including consent/assent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including attending the required trial visits).
  2. Male or female participants between 2 to less than 18 years of age at the time of providing informed consent/assent. Age groups are enrolled in a staggered fashion respectively: 6 participants in the 12 to less than 18 years of age group followed by 6 participants in the 2 to less than 12 years of age group at the time of providing informed consent/assent.
  3. Diagnosed with Generalized Myasthenia Gravis (gMG) with confirmed documentation
  4. Meeting the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, and IVa.
  5. Eligible participants should have an unsatisfactory response (efficacy and/or safety) to immunosuppressants, steroids or acetylcholinesterase (AChE) inhibitors and should be on stable concomitant Generalized Myasthenia Gravis (gMG) therapy of adequate duration before screening.
  6. Positive serologic test for acetylcholine receptor (anti-AChR) antibodies at screening (for younger participants (<15kg) historical values can be used).
  7. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.

    1. Male participants: Male participants must agree to not donate sperm from the time the informed consent form was signed until the end of the trial.
    2. Female participants: Female adolescents of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before investigational medicinal product (IMP) can be administered.

Exclusion Criteria:

  1. Participants with Myasthenia Gravis Foundation of America (MGFA) class I, IVb, and V.
  2. Female adolescents of childbearing potential (FAOCBP): Pregnancy or lactation, or the participant intends to become pregnant during the trial or within 90 days after the last dose of investigational medicinal product (IMP).
  3. 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 recurrence for ≥3 years before the first administration of the investigational medicinal product (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 have had a recent major surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the trial or put the participant at undue risk
  4. Worsening muscle weakness secondary to concurrent infections or medications (aminoglycosides, fluoro-quinolones, beta-blockers, etc).
  5. A documented lack of clinical response to plasma exchange (PLEX).
  6. Received a live or live-attenuated vaccine fewer than 28 days before screening. Receiving an inactivated, subunit, polysaccharide, or conjugate vaccine any time before screening is not exclusionary.
  7. Received a thymectomy <3 months before screening or 1 is planned to be performed during the trial period.
  8. The following results from these diagnostic assessments will be considered exclusionary:

    1. Positive serum test at screening for an active viral infection with any of the following conditions:

      • Hepatitis B virus (HBV) that is indicative of an acute or chronic infection
      • Hepatitis C virus (HCV) based on HCV antibody assay
      • Human immunodeficiency virus (HIV) associated with a CD4 count <200 cells/mm3 with an acquired immunodeficiency syndrome (AIDS)-defining condition, such as: Cytomegalovirus retinitis with loss of vision, Pneumocystis jiroveci pneumonia, chronic intestinal cryptosporidiosis, HIV-related encephalopathy, Mycobacterium tuberculosis (pulmonary or extrapulmonary), or invasive cervical cancer
    2. Positive nasopharyngeal swab polymerase chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening.
  9. Using the following prior or concomitant therapies:

    1. Use of an investigational product within 3 months or 5 half-lives (whichever is longer) before the first dose of the investigational medicinal product (IMP).
    2. Use of any monoclonal antibody within the 6 months before the first dose of the investigational medicinal product (IMP).
    3. Use of intravenous immunoglobulin (IVIg), administered subcutaneously or intramuscularly, or Plasma exchange (PLEX) within 4 weeks before screening.
  10. Total immunoglobulin (IgG) levels <6 g/L below the lower limit of normal (LLN) according to the reference ranges of the central laboratory for participant by sex and age at screening.
  11. A known hypersensitivity reaction to efgartigimod or any of its excipients.

Sites / Locations

  • Investigator Site - US0010120Recruiting
  • Investigator Site - US0010003
  • Investigator site - US0010142Recruiting
  • Investigator Site - AT0430010
  • Investigator Site - BE0320021Recruiting
  • Investigator Site - FR0330032
  • Investigator Site - FR0330041
  • Investigator Site - GEO9950017Recruiting
  • Investigator Site - GEO9950018
  • Investigator site DE0490034
  • Investigator Site - DE0490032
  • Investigator Site - IT0390047
  • Investigator Site - IT0390048
  • Investigator Site - NL0310001Recruiting
  • Investigator Site - PL0480035Recruiting
  • Investigator Site - PL0480038Recruiting
  • Investigator Site - PL0480034Recruiting
  • Investigator Site - ES0340040
  • Investigator Site - ES0340041Recruiting
  • Investigator site - UK440035
  • Investigator site UK0440027
  • Investigator site - UK440024

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Efgartigimod

Arm Description

Patients receiving efgartigimod intravenous (IV) treatment

Outcomes

Primary Outcome Measures

Efgartigimod concentrations as input for compartmental, model-driven analysis to determine (age and size dependency of) Clearance (CL)
Blood samples will be collected from each participant for measurement of serum concentrations of efgartigimod
Efgartigimod concentrations as input for compartmental, model-driven analysis to determine (age and size dependency of) Volume of Distribution (Vd)
Blood samples will be collected from each participant for measurement of serum concentrations of efgartigimod
Total Immunoglobulin G (IgG) levels as input for pharmacokinetics (PK) and pharmacodynamics (PD) modeling analysis
Total Immunoglobulin G levels will be measured from blood samples
Anti-acetylcholine receptors antibodies (AChR-Ab) as input for pharmacokinetics (PK) and pharmacodynamics (PD) modeling analysis
Total Immunoglobulin G (IgG) levels will be measured from blood samples

Secondary Outcome Measures

Incidence and severity of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Efgartigimod serum concentrations from blood samples
Absolute values of levels of total Immunoglobulin G (IgG) from blood samples
Change from baseline of levels of total Immunoglobulin G (IgG) from blood samples
Percentage change from baseline of total Immunoglobulin G (IgG) from blood samples
Absolute values of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples
Change from baseline of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples
Percentage change from baseline of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples
Incidence of anti-drug antibodies (ADAs) against efgartigimod in serum samples
Prevalence of anti-drug antibodies (ADAs) against efgartigimod in serum samples
Absolute values of total Myasthenia Gravis Activity of Daily Living (MG-ADL) score. Total score can range from 0 to 24, with higher total scores indicating more impairment.
Change from baseline of total Myasthenia Gravis Activity of Daily Living (MG-ADL) score. Total score can range from 0 to 24, with higher total scores indicating more impairment.
Absolute values of total Quantitative Myasthenia Gravis Score (QMG score). The total possible score is 39, where higher total scores indicate more severe impairments.
Change from baseline of total Myasthenia Gravis Score (QMG score). The total possible score is 39, where higher total scores indicate more severe impairments.
Absolute values of total score EuroQoL 5 Dimensions Youth (EQ-5D-Y)
Description of the participant's health state is done by digits for 5 dimensions combined in a 5-digit number. A unique health state is defined by combining 1 level from each of the 5 dimensions. Each state is referred to in terms of a 5-digit code, whereas code 11111 would indicate no problems in any of the 5 dimensions and 33333 would indicate worst problems in any of the 5 dimensions.
Change from baseline of total score EuroQoL 5 Dimensions Youth (EQ-5D-Y)
Description of the participant's health state is done by digits for 5 dimensions combined in a 5-digit number. A unique health state is defined by combining 1 level from each of the 5 dimensions. Each state is referred to in terms of a 5-digit code, whereas code 11111 would indicate no problems and 33333 would indicate worst problems in any of the 5 dimensions.
Values of Neurological Quality of Life (Neuro-QoL) pediatric fatigue questionnaire
Change from baseline of Neurological Quality of Life (Neuro-QoL) pediatric fatigue questionnaire
Change in protective antibody titers to vaccines received before or during the trial from blood samples

Full Information

First Posted
March 16, 2021
Last Updated
October 2, 2023
Sponsor
argenx
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1. Study Identification

Unique Protocol Identification Number
NCT04833894
Brief Title
Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis
Official Title
Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to investigate the PK, PD, safety, and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG. Trial details include: The maximum trial duration for each individual participant will be approximately 28 weeks The treatment duration will be 8 weeks for the dose-confirmatory part (Part A) and 18 weeks for the treatment response-confirmatory part (Part B)

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 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Efgartigimod
Arm Type
Experimental
Arm Description
Patients receiving efgartigimod intravenous (IV) treatment
Intervention Type
Biological
Intervention Name(s)
Efgartigimod IV
Intervention Description
Intravenous infusion of Efgartigimod
Primary Outcome Measure Information:
Title
Efgartigimod concentrations as input for compartmental, model-driven analysis to determine (age and size dependency of) Clearance (CL)
Description
Blood samples will be collected from each participant for measurement of serum concentrations of efgartigimod
Time Frame
up to 26 weeks
Title
Efgartigimod concentrations as input for compartmental, model-driven analysis to determine (age and size dependency of) Volume of Distribution (Vd)
Description
Blood samples will be collected from each participant for measurement of serum concentrations of efgartigimod
Time Frame
up to 26 weeks
Title
Total Immunoglobulin G (IgG) levels as input for pharmacokinetics (PK) and pharmacodynamics (PD) modeling analysis
Description
Total Immunoglobulin G levels will be measured from blood samples
Time Frame
up to 26 weeks
Title
Anti-acetylcholine receptors antibodies (AChR-Ab) as input for pharmacokinetics (PK) and pharmacodynamics (PD) modeling analysis
Description
Total Immunoglobulin G (IgG) levels will be measured from blood samples
Time Frame
up to 26 weeks
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time Frame
up to 28 weeks
Title
Efgartigimod serum concentrations from blood samples
Time Frame
up to 26 weeks
Title
Absolute values of levels of total Immunoglobulin G (IgG) from blood samples
Time Frame
up to 26 weeks
Title
Change from baseline of levels of total Immunoglobulin G (IgG) from blood samples
Time Frame
up to 26 weeks
Title
Percentage change from baseline of total Immunoglobulin G (IgG) from blood samples
Time Frame
up to 26 weeks
Title
Absolute values of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples
Time Frame
up to 26 weeks
Title
Change from baseline of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples
Time Frame
up to 26 weeks
Title
Percentage change from baseline of anti-acetylcholine receptor antibodies (AChR-Ab) from blood samples
Time Frame
up to 26 weeks
Title
Incidence of anti-drug antibodies (ADAs) against efgartigimod in serum samples
Time Frame
up to 28 weeks
Title
Prevalence of anti-drug antibodies (ADAs) against efgartigimod in serum samples
Time Frame
up to 28 weeks
Title
Absolute values of total Myasthenia Gravis Activity of Daily Living (MG-ADL) score. Total score can range from 0 to 24, with higher total scores indicating more impairment.
Time Frame
up to 26 weeks
Title
Change from baseline of total Myasthenia Gravis Activity of Daily Living (MG-ADL) score. Total score can range from 0 to 24, with higher total scores indicating more impairment.
Time Frame
up to 26 weeks
Title
Absolute values of total Quantitative Myasthenia Gravis Score (QMG score). The total possible score is 39, where higher total scores indicate more severe impairments.
Time Frame
up to 26 weeks
Title
Change from baseline of total Myasthenia Gravis Score (QMG score). The total possible score is 39, where higher total scores indicate more severe impairments.
Time Frame
up to 26 weeks
Title
Absolute values of total score EuroQoL 5 Dimensions Youth (EQ-5D-Y)
Description
Description of the participant's health state is done by digits for 5 dimensions combined in a 5-digit number. A unique health state is defined by combining 1 level from each of the 5 dimensions. Each state is referred to in terms of a 5-digit code, whereas code 11111 would indicate no problems in any of the 5 dimensions and 33333 would indicate worst problems in any of the 5 dimensions.
Time Frame
up to 26 weeks
Title
Change from baseline of total score EuroQoL 5 Dimensions Youth (EQ-5D-Y)
Description
Description of the participant's health state is done by digits for 5 dimensions combined in a 5-digit number. A unique health state is defined by combining 1 level from each of the 5 dimensions. Each state is referred to in terms of a 5-digit code, whereas code 11111 would indicate no problems and 33333 would indicate worst problems in any of the 5 dimensions.
Time Frame
up to 26 weeks
Title
Values of Neurological Quality of Life (Neuro-QoL) pediatric fatigue questionnaire
Time Frame
up to 26 weeks
Title
Change from baseline of Neurological Quality of Life (Neuro-QoL) pediatric fatigue questionnaire
Time Frame
up to 26 weeks
Title
Change in protective antibody titers to vaccines received before or during the trial from blood samples
Time Frame
up to 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability of the participant and/or his/her legally authorized representative to understand the requirements of the trial and provide written informed consent/assent, if applicable (including consent/assent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including attending the required trial visits). Male or female participants between 2 to less than 18 years of age at the time of providing informed consent/assent. Age groups are enrolled in a staggered fashion respectively: 6 participants in the 12 to less than 18 years of age group followed by 6 participants in the 2 to less than 12 years of age group at the time of providing informed consent/assent. Diagnosed with Generalized Myasthenia Gravis (gMG) with confirmed documentation Meeting the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, and IVa. Eligible participants should have an unsatisfactory response (efficacy and/or safety) to immunosuppressants, steroids or acetylcholinesterase (AChE) inhibitors and should be on stable concomitant gMG therapy of adequate duration before screening. Positive serologic test for acetylcholine receptor (anti-AChR) antibodies at screening (for younger participants (<15kg) historical values can be used). Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. Male participants: Male participants must agree to not donate sperm from of providing informed consent/assent until they have completed the trial. Female participants: Female adolescents of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before investigational medicinal product (IMP) can be administered. Exclusion Criteria: Participants with MGFA class I, IVb, and V. Female adolescents of childbearing potential: Pregnancy or lactation, or the participant intends to become pregnant during the trial or within 90 days after the last dose of IMP. 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 recurrence for ≥3 years before the first administration of 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 Clinical evidence of other significant serious diseases, or have had a recent major surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the trial or put the participant at undue risk Worsening muscle weakness secondary to concurrent infections or medications (aminoglycosides, fluoro-quinolones, beta-blockers, etc). A documented lack of clinical response to plasma exchange (PLEX). Received a live or live-attenuated vaccine fewer than 28 days before screening. Receiving an inactivated, subunit, polysaccharide, or conjugate vaccine any time before screening is not exclusionary. Received a thymectomy <3 months before screening or 1 is planned to be performed during the trial period. The following results from these diagnostic assessments will be considered exclusionary: a. Positive serum test at screening for an active viral infection with any of the following conditions: Hepatitis B virus (HBV) that is indicative of an acute or chronic infection; Hepatitis C virus (HCV) based on HCV antibody assay; Positive HIV serology at screening; Positive nasopharyngeal swab polymerase chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening. Using the following prior or concomitant therapies: Use of an investigational product within 3 months or 5 half-lives (whichever is longer) before the first dose of IMP, Use of any monoclonal antibody within the 6 months before the first dose of IMP, Use of intravenous immunoglobulin (IVIg), administered subcutaneously or intramuscularly, or PLEX within 4 weeks before screening. Total immunoglobulin (IgG) levels <6 g/L below the lower limit of normal (LLN) according to the reference ranges of the central laboratory for participant by sex and age at screening. A known hypersensitivity reaction to efgartigimod or any of its excipients. Current participation in another interventional clinical trial or previous participation in an efgartigimod trial with at least 1 dose of IMP received. History (within 12 months of screening) of current alcohol, drug, or medication abuse as assessed by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
ClinicalTrials@argenx.com
Facility Information:
Facility Name
Investigator Site - US0010120
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site - US0010003
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site - US0010142
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator Site - AT0430010
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site - BE0320021
City
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site - FR0330032
City
Marseille
ZIP/Postal Code
13004
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site - FR0330041
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site - GEO9950017
City
Tbilisi
ZIP/Postal Code
0177
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site - GEO9950018
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site DE0490034
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site - DE0490032
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site - IT0390047
City
Florence
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site - IT0390048
City
Genova
ZIP/Postal Code
16147
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site - NL0310001
City
Leiden
ZIP/Postal Code
2333
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site - PL0480035
City
Gdańsk
State/Province
Woj. Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site - PL0480038
City
Katowice
State/Province
Woj. Slaskie
ZIP/Postal Code
40-123
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site - PL0480034
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site - ES0340040
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
8573504834
Email
clinicaltrials@argenx.com
Facility Name
Investigator Site - ES0340041
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site - UK440035
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site UK0440027
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site - UK440024
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis

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