A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)
NCT06987539 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2026-05-14
Summary
The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of inebilizumab administered in pediatric participants with gMG, and to assess the safety and tolerability of inebilizumab administered in pediatric participants with gMG.
Conditions
Interventions
- DRUG
-
Inebilizumab
Inebilizumab will be administered IV.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2030-03-13
- Completion
- 2030-03-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases
NCT01884311 ·Status: COMPLETED ·Phase: PHASE3
-
Intravenous Mepolizumab In Children With Eosinophilic Esophagitis
NCT00358449 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Effectiveness of h5G1.1-mAb for Dermatomyositis
NCT00005571 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)
NCT06450639 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy
NCT00329381 ·Status: COMPLETED ·Phase: PHASE4
-
A Clinical Trial Evaluating the Safety and Effectiveness of Golimumab in Patients With Severe, Persistent Asthma
NCT00675649 ·Status: WITHDRAWN ·Phase: PHASE2
-
Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Subcutaneously in Children
NCT02377427 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Effect of Xolair(Omalizumab) on Improving the Tolerability of Specific Immunotherapy in Patients With at Least Moderate Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids
NCT00691873 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
NCT01803321 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa
NCT06921850 ·Status: RECRUITING ·Phase: PHASE3
-
Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease
NCT02980263 ·Status: WITHDRAWN ·Phase: PHASE2
-
Omalizumab to Accelerate a Symptom-driven Multi-food OIT
NCT04045301 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis
NCT00589628 ·Status: COMPLETED ·Phase: PHASE4
-
A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab) in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy
NCT00639691 ·Status: COMPLETED ·Phase: PHASE4
-
An Interventional Study of Infigratinib in Children With Hypochondroplasia
NCT06873035 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2/PHASE3
-
Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
NCT03881696 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Belimumab Administered Subcutaneously to Healthy Subjects
NCT01583530 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)
NCT03790332 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study to Investigate Safety, Efficacy of an Anti-IFNγ mAb in Children With Primary Haemophagocytic Lymphohistiocytosis
NCT01818492 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
NCT01750697 ·Status: COMPLETED ·Phase: PHASE2
-
Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.
NCT00500539 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome
NCT03098797 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF)
NCT01148797 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects
NCT01922336 ·Status: COMPLETED ·Phase: PHASE1
-
Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis
NCT00635089 ·Status: COMPLETED ·Phase: PHASE3