Trial · NCT05265273
A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
NCT05265273, Phase 2, Phase 3, Recruiting, Janssen Research & Development, LLC
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis. Trials, record NCT05265273. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05265273
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
- NCT number
- NCT05265273
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 12 participants, estimated
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Myasthenia Gravis
- Interventions
- Nipocalimab
- First posted
- 2022-03-03
- Last updated
- 2026-11-04
- Other registries' IDs
- eudract:2021-002479-20
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in Total Serum Immunoglobulin-G (IgG) Levels | Up to 3 years | Change from baseline in total serum IgG levels were reported. |
| Primary | Number of Participants with Infectious Adverse Events (AEs) | Up to 3 years | 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. |
| Primary | Number of Participants with Serious AEs (SAEs) | Up to 3 years | 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. |
| Primary | Number of Participants with Adverse Events of Special Interests (AESIs) | Up to 3 years | 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 \[g/dL\]) c) opportunistic infections and d) Serious and non-serious deep-vein thrombosis (DVT) and/or pulmonary embolism (PE). Any AE occurring at or after the initial administration of study intervention through end of study is treatment emergent. |
| Primary | Number of Participants with Abnormalities in Clinical Laboratory Tests | Up to 3 years | Number of participants with abnormalities in clinical laboratory tests (including chemistry, hematology, coagulation, and urinalysis) will be reported. |
| Primary | Number of Participants with Abnormalities in Vital Signs | Up to 3 years | 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. |
| Primary | Number of Participants with Abnormalities in Physical Examination | Up to 3 years | 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. |
| Primary | Serum Concentration of Nipocalimab over Time | Up to 3 years | Serum samples will be analyzed to determine concentrations of nipocalimab using a validated, specific, and sensitive immunoassay method. |
| Primary | Clearance (CL) of Nipocalimab | Up to 3 years | CL is defined as the volume of serum from which nipocalimab is completely removed per unit time. |
| Primary | Volume of Distribution (V) of Nipocalimab | Up to 3 years | V is defined as the representation of nipocalimab's propensity to either remain in the serum or redistribute to other tissue compartments. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05265273
GET https://conductscience.org/api/trials/v1/NCT05265273/registered?page=2