Back to resultsA Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
Primary Purpose
Myasthenia Gravis
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nipocalimab
Sponsored by
About this trial
This is an interventional treatment trial for Myasthenia Gravis focused on measuring Pediatric
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class IIa/b, IIIa/b, or IVa/b at screening
- Has a positive serologic test for acetylcholine receptor (anti-AChR) antibodies or muscle-specific tyrosine kinase (anti-MuSK) antibodies at screening
- A participant using herbal, naturopathic, traditional Chinese remedies, ayurvedic or nutritional supplements, or medical marijuana (with a doctor's prescription) is eligible if the use of these medications is acceptable to the Investigator. These remedies must remain at a stable dose and regimen throughout the study
- Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
- Participants should have a body weight and body mass index between 5th and 95th percentile for age and sex. Obese participants greater than 95th percentile and underweight participants below 5th percentile may participate following medical clearance
- A female of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at Screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention
Exclusion Criteria:
- Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/ autoimmune hepatitis/ cirrhosis/ and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular (including congenital heart diseases), psychiatric, neurological musculoskeletal disorder, any other medical disorder(s) (example, diabetes mellitus), or clinically significant abnormalities in screening laboratory, that might interfere with participant's full participation in the study, and/ or might jeopardize the safety of the participant or the validity of the study results
- Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her generalized myasthenia gravis (gMG), or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
- Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the Active treatment Phase of the study
- Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis to therapeutic proteins (example, monoclonal antibodies)
- Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening
Sites / Locations
- Phoenix Children's HospitalRecruiting
- Lucile Packard Children's Hospital StanfordRecruiting
- UCSF Benioff Children's HospitalRecruiting
- Children's Hospital ColoradoRecruiting
- University of South Florida Morsani Center for Advanced HealthcareRecruiting
- University of Kansas Medical CenterRecruiting
- C.S. Mott Children's HospitalRecruiting
- Childrens Hospital Of PhiladelphiaRecruiting
- Nagano Children's HospitalRecruiting
- Chiba University HospitalRecruiting
- University of Miyazaki HospitalRecruiting
- Saitama Prefecture Children's Medical CenterRecruiting
- Tokyo Women's Medical University HospitalRecruiting
- Leiden University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nipocalimab
Arm Description
Participants aged 2 to less than [<] 18 years of age will receive nipocalimab once every two weeks for 24 weeks. After Week 24, all participants will have the option to enroll in long term extension (LTE).
Outcomes
Primary Outcome Measures
Change from Baseline in Total Serum Immunoglobulin-G (IgG) Antibodies Levels
Change from baseline in total serum IgG antibodies levels were reported.
Number of Participants with Infectious Adverse Events (AEs)
Number of participants with infectious AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants with Serious AEs (SAEs)
Number of participants with SAEs will be reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important to prevent one of the outcomes listed above.
Number of Participants with Adverse Events of Special Interests (AESIs)
Number of participants with AESIs will be reported. Treatment-emergent AEs associated with the following situations are considered an AESI: a) infections that are severe or require intravenous (IV) anti-infective or operative/invasive intervention; b) hypoalbuminemia with albumin less than (<)20 grams per liter (g/L) [<] 2.0 grams per deciliter [g/dL]) and c) opportunistic infections. Any AE occurring at or after the initial administration of study intervention through end of study is treatment emergent.
Number of Participants with Abnormalities in Clinical Laboratory Tests
Number of participants with abnormalities in clinical laboratory tests (including chemistry, hematology, coagulation, and urinalysis) will be reported.
Number of Participants with Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs including sitting pulse/heart rate, sitting systolic and diastolic blood pressure, and oral temperature (degrees Celsius) will be reported.
Number of Participants with Abnormalities in Physical Examination
Number of participants with abnormalities in physical examinations including height, weight, assessments of the skin, head, eyes, ears, nose, throat, neck, thyroid, lungs, heart, abdomen, lymph nodes and extremities will be reported.
Serum Concentration of Nipocalimab over Time
Serum samples will be analyzed to determine concentrations of nipocalimab using a validated, specific, and sensitive immunoassay method.
Clearance (CL) of Nipocalimab
CL is defined as the volume of serum from which nipocalimab is completely removed per unit time.
Volume of Distribution (V) of Nipocalimab
V is defined as the representation of nipocalimab's propensity to either remain in the serum or redistribute to other tissue compartments.
Half-life (t1/2) of Nipocalimab
t1/2 is defined as the time it takes for nipocalimab's active substance in the body to reduce by half.
Steady-state Peak Concentration (Cpeak,ss) of Nipocalimab
Cpeak,ss is defined as the peak serum concentration of nipocalimab at steady state.
Steady-state Trough concentration (Ctrough,ss) of Nipocalimab
Ctrough,ss will be reported. It is defined as the observed serum concentration of nipocalimab just prior to the beginning of a dosing interval at steady state.
Steady-state Area Under the Curve (AUCss) of Nipocalimab
AUCss is defined as the area under the curve for nipocalimab at steady state.
Secondary Outcome Measures
Change from Baseline in Myasthenia Gravis -Activities of Daily Living (MG-ADL) Score
Change from baseline in MG-ADL score will be reported. The MG-ADL score provides a rapid assessment of the participant's myasthenia gravis (MG) symptom severity. Eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, eyelid droop) are rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score will be sum of eight function scores and can range from 0 to 24. A higher score indicates greater symptom severity.
Change in the Quantitative Myasthenia Gravis (QMG) Score
The QMG score is a standardized quantitative strength assessment comprising 13 components (and is administered by a trained qualified healthcare professional [HCP] eg, physician, physician assistant, nurse practitioner, nurse). The quantitative results of each strength component are mapped to the following 4-point scale: 0 equals to (=) none, 1 = mild, 2 = moderate and 3 = severe. The total score will be sum of 13 components scores and can range from 0 to 39. A higher score indicates greater weakness.
European Quality of Life 5-Dimension Youth (EQ-5D-Y) Tool Score
The EQ-5D-Y is a standardized child friendly instrument for use as a measure of health status, primarily designed for self-completion by children and adolescents, or via a proxy version to be completed by the child's caregiver. The EQ-5D-Y descriptive system comprises the following 5 dimensions: Mobility, looking after myself (washing and dressing), usual activities, pain or discomfort and feeling worried or unhappy. Each of the 5 dimensions is divided into 3 levels of perceived problems (Level 1 indicating no problem, Level 2 indicating some problems, Level 3 a lot of problems).
Neurological Quality of Life (Neuro-QoL) Pediatric Fatigue Score
The Neuro-QoL pediatric fatigue score will be used to assess the impact of fatigue in participants aged 10 to less than (<) 18 years. The participant will rate each of the 11 items on a 5-point scale. Higher scores indicate greater fatigue.
Patient Global Impression of Severity (PGI-S) Score
The PGI-S score will be used to assess the severity of fatigue due to generalized myasthenia gravis (gMG) in participants aged 10 to < 18 years. Participants will be asked to rate their fatigue over the past 7 days using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe. Higher scores indicate greater severity of fatigue.
Patient Global Impression of Change (PGI-C) Score
The PGI-C score will be used to assess if there has been an improvement or decline in patient-reported fatigue since the beginning of the treatment in participants aged 10 to <18 years. Participants will be asked to rate their current fatigue as compared to when they started the study, using the following 7-point scale: 1 = Much better, 2 = Moderately better, 3 = A little better, 4 = No change, 5 = A little worse, 6 = Moderately worse, and 7 = Much worse. Higher scores indicate greater change in overall fatigue.
Number of Participants with Anti-Drug Antibodies [ADAs] to Nipocalimab
Number of participants with ADAs to nipocalimab will be reported.
Number of Participants with Neutralizing Antibodies (NAbs) to Nipocalimab
Number of participants with NAbs to nipocalimab will be reported.
Number of Participants with Vaccine Antibody Titers to Diphtheria or Tetanus
Number of participants with vaccine antibody titers to diphtheria or tetanus will be reported.
Full Information
NCT ID
NCT05265273
First Posted
February 22, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05265273
Brief Title
A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
Official Title
An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2022 (Actual)
Primary Completion Date
March 19, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
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 study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (<) 18 years of age, the safety and tolerability of treatment with nipocalimab in children and adolescents and to evaluate the pharmacokinetics (PK) of nipocalimab in children and adolescents with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard-of-care therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis
Keywords
Pediatric
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
Nipocalimab
Arm Type
Experimental
Arm Description
Participants aged 2 to less than [<] 18 years of age will receive nipocalimab once every two weeks for 24 weeks. After Week 24, all participants will have the option to enroll in long term extension (LTE).
Intervention Type
Drug
Intervention Name(s)
Nipocalimab
Other Intervention Name(s)
M281/JNJ-80202135
Intervention Description
Nipocalimab will be administered as an IV infusion.
Primary Outcome Measure Information:
Title
Change from Baseline in Total Serum Immunoglobulin-G (IgG) Antibodies Levels
Description
Change from baseline in total serum IgG antibodies levels were reported.
Time Frame
Up to 3 years
Title
Number of Participants with Infectious Adverse Events (AEs)
Description
Number of participants with infectious AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time Frame
Up to 3 years
Title
Number of Participants with Serious AEs (SAEs)
Description
Number of participants with SAEs will be reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important to prevent one of the outcomes listed above.
Time Frame
Up to 3 years
Title
Number of Participants with Adverse Events of Special Interests (AESIs)
Description
Number of participants with AESIs will be reported. Treatment-emergent AEs associated with the following situations are considered an AESI: a) infections that are severe or require intravenous (IV) anti-infective or operative/invasive intervention; b) hypoalbuminemia with albumin less than (<)20 grams per liter (g/L) [<] 2.0 grams per deciliter [g/dL]) and c) opportunistic infections. Any AE occurring at or after the initial administration of study intervention through end of study is treatment emergent.
Time Frame
Up to 3 years
Title
Number of Participants with Abnormalities in Clinical Laboratory Tests
Description
Number of participants with abnormalities in clinical laboratory tests (including chemistry, hematology, coagulation, and urinalysis) will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with Abnormalities in Vital Signs
Description
Number of participants with abnormalities in vital signs including sitting pulse/heart rate, sitting systolic and diastolic blood pressure, and oral temperature (degrees Celsius) will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with Abnormalities in Physical Examination
Description
Number of participants with abnormalities in physical examinations including height, weight, assessments of the skin, head, eyes, ears, nose, throat, neck, thyroid, lungs, heart, abdomen, lymph nodes and extremities will be reported.
Time Frame
Up to 3 years
Title
Serum Concentration of Nipocalimab over Time
Description
Serum samples will be analyzed to determine concentrations of nipocalimab using a validated, specific, and sensitive immunoassay method.
Time Frame
Up to 3 years
Title
Clearance (CL) of Nipocalimab
Description
CL is defined as the volume of serum from which nipocalimab is completely removed per unit time.
Time Frame
Up to 3 years
Title
Volume of Distribution (V) of Nipocalimab
Description
V is defined as the representation of nipocalimab's propensity to either remain in the serum or redistribute to other tissue compartments.
Time Frame
Up to 3 years
Title
Half-life (t1/2) of Nipocalimab
Description
t1/2 is defined as the time it takes for nipocalimab's active substance in the body to reduce by half.
Time Frame
Up to 3 years
Title
Steady-state Peak Concentration (Cpeak,ss) of Nipocalimab
Description
Cpeak,ss is defined as the peak serum concentration of nipocalimab at steady state.
Time Frame
Up to 3 years
Title
Steady-state Trough concentration (Ctrough,ss) of Nipocalimab
Description
Ctrough,ss will be reported. It is defined as the observed serum concentration of nipocalimab just prior to the beginning of a dosing interval at steady state.
Time Frame
Up to 3 years
Title
Steady-state Area Under the Curve (AUCss) of Nipocalimab
Description
AUCss is defined as the area under the curve for nipocalimab at steady state.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Change from Baseline in Myasthenia Gravis -Activities of Daily Living (MG-ADL) Score
Description
Change from baseline in MG-ADL score will be reported. The MG-ADL score provides a rapid assessment of the participant's myasthenia gravis (MG) symptom severity. Eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, eyelid droop) are rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score will be sum of eight function scores and can range from 0 to 24. A higher score indicates greater symptom severity.
Time Frame
Up to 3 years
Title
Change in the Quantitative Myasthenia Gravis (QMG) Score
Description
The QMG score is a standardized quantitative strength assessment comprising 13 components (and is administered by a trained qualified healthcare professional [HCP] eg, physician, physician assistant, nurse practitioner, nurse). The quantitative results of each strength component are mapped to the following 4-point scale: 0 equals to (=) none, 1 = mild, 2 = moderate and 3 = severe. The total score will be sum of 13 components scores and can range from 0 to 39. A higher score indicates greater weakness.
Time Frame
Up to 3 years
Title
European Quality of Life 5-Dimension Youth (EQ-5D-Y) Tool Score
Description
The EQ-5D-Y is a standardized child friendly instrument for use as a measure of health status, primarily designed for self-completion by children and adolescents, or via a proxy version to be completed by the child's caregiver. The EQ-5D-Y descriptive system comprises the following 5 dimensions: Mobility, looking after myself (washing and dressing), usual activities, pain or discomfort and feeling worried or unhappy. Each of the 5 dimensions is divided into 3 levels of perceived problems (Level 1 indicating no problem, Level 2 indicating some problems, Level 3 a lot of problems).
Time Frame
Up to 3 years
Title
Neurological Quality of Life (Neuro-QoL) Pediatric Fatigue Score
Description
The Neuro-QoL pediatric fatigue score will be used to assess the impact of fatigue in participants aged 10 to less than (<) 18 years. The participant will rate each of the 11 items on a 5-point scale. Higher scores indicate greater fatigue.
Time Frame
Up to 3 years
Title
Patient Global Impression of Severity (PGI-S) Score
Description
The PGI-S score will be used to assess the severity of fatigue due to generalized myasthenia gravis (gMG) in participants aged 10 to < 18 years. Participants will be asked to rate their fatigue over the past 7 days using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe. Higher scores indicate greater severity of fatigue.
Time Frame
Up to 3 years
Title
Patient Global Impression of Change (PGI-C) Score
Description
The PGI-C score will be used to assess if there has been an improvement or decline in patient-reported fatigue since the beginning of the treatment in participants aged 10 to <18 years. Participants will be asked to rate their current fatigue as compared to when they started the study, using the following 7-point scale: 1 = Much better, 2 = Moderately better, 3 = A little better, 4 = No change, 5 = A little worse, 6 = Moderately worse, and 7 = Much worse. Higher scores indicate greater change in overall fatigue.
Time Frame
Up to 3 years
Title
Number of Participants with Anti-Drug Antibodies [ADAs] to Nipocalimab
Description
Number of participants with ADAs to nipocalimab will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with Neutralizing Antibodies (NAbs) to Nipocalimab
Description
Number of participants with NAbs to nipocalimab will be reported.
Time Frame
Up to 3 years
Title
Number of Participants with Vaccine Antibody Titers to Diphtheria or Tetanus
Description
Number of participants with vaccine antibody titers to diphtheria or tetanus will be reported.
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class IIa/b, IIIa/b, or IVa/b at screening
Has a positive serologic test for acetylcholine receptor (anti-AChR) antibodies or muscle-specific tyrosine kinase (anti-MuSK) antibodies at screening
A participant using herbal, naturopathic, traditional Chinese remedies, ayurvedic or nutritional supplements, or medical marijuana (with a doctor's prescription) is eligible if the use of these medications is acceptable to the Investigator. These remedies must remain at a stable dose and regimen throughout the study
Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
Participants should have a body weight and body mass index between 5th and 95th percentile for age and sex. Obese participants greater than 95th percentile and underweight participants below 5th percentile may participate following medical clearance
A female of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at Screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention
Exclusion Criteria:
Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/ autoimmune hepatitis/ cirrhosis/ and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular (including congenital heart diseases), psychiatric, neurological musculoskeletal disorder, any other medical disorder(s) (example, diabetes mellitus), or clinically significant abnormalities in screening laboratory, that might interfere with participant's full participation in the study, and/ or might jeopardize the safety of the participant or the validity of the study results
Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her generalized myasthenia gravis (gMG), or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the Active treatment Phase of the study
Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis to therapeutic proteins (example, monoclonal antibodies)
Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Name
Lucile Packard Children's Hospital Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Name
UCSF Benioff Children's Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
University of South Florida Morsani Center for Advanced Healthcare
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Medical Center
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States
Individual Site Status
Recruiting
Facility Name
C.S. Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Childrens Hospital Of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Individual Site Status
Recruiting
Facility Name
Nagano Children's Hospital
City
Azumino-shi, Nagano
ZIP/Postal Code
399-8288
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Miyazaki Hospital
City
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Prefecture Children's Medical Center
City
Saitama-shi
ZIP/Postal Code
330-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
ZIP/Postal Code
162-8666
Country
Japan
Individual Site Status
Recruiting
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
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