Evaluation of Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants With Generalized Myasthenia Gravis (gMG)

Study Purpose

The primary purpose of this study is to characterize the pharmacokinetics and pharmacodynamics of treatment with ravulizumab intravenous infusion in pediatric participants with gMG.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosis of gMG confirmed by a positive serologic test for anti-AChR antibodies (Abs) obtained at Screening and/or during Screening Period.

- Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to Class IV at Screening.

- Participants receiving treatment must be on a stable dosing regimen of adequate duration prior to Screening and during the Screening Period.

- Eculizumab-experienced participants must have been enrolled and treated with eculizumab in Study ECU-MG-303 for at least 6 months (180 days) and must have been on a stable dose for ≥ 2 months (60 days) prior to Screening.

- All participants must be vaccinated against meningococcal infection.

Exclusion Criteria:

Medical Conditions.

- Any untreated thymic malignancy, carcinoma, or thymoma.

- Participants with a history of treated benign thymoma.

- History of thymectomy, thymomectomy, or any thymic surgery within the 12 months prior to Screening.

- History of N meningitidis infection.

- Known to be human immunodeficiency virus (HIV) positive.

- History of unexplained infections.

- Known or suspected history of drug or alcohol abuse or dependence within 1 year prior to the start of the Screening Period

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05644561
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Alexion Pharmaceuticals, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	France, Italy, Japan, Netherlands, Serbia, Spain, Switzerland, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Generalized Myasthenia Gravis, gMG

Arms & Interventions

Arms

Experimental: Ravulizumab Intravenous (IV) Infusion

All participants will receive a weight-based loading dose of ravulizumab IV on Day 1, followed by weight-based maintenance dose of ravulizumab on Day 15 and once every 8 weeks (q8w) thereafter for participants weighing ≥ 20 kg, or once every 4 weeks (q4w) for participants weighing < 20 kg, for a total of 122 weeks of treatment.

Interventions

Drug: - Ravulizumab

Ravulizumab will be administered by intravenous (IV) infusion.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Los Angeles 5368361, California 5332921

Status

Recruiting

Address

Research Site

Los Angeles 5368361, California 5332921, 90078

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