Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis

Study Purpose

The purpose of this trial is to evaluate the long-term safety of efgartigimod IV and efgartigimod PH20 SC administered to participants with gMG in the antecedent studies, ARGX-113-2006 and ARGX-113-2207, respectively.

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 2 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Participants are eligible to be included in the trial only if all of the following criteria apply: 1. The participant completed ARGX-113-2006 or ARGX-113-2207, defined as: 1. The participant reached End of Trial in trial ARGX-113-2006 or End of Study in ARGX-113-2207 and agreed to participate in the ARGX-113-2008 trial. 2. The participant qualifies for retreatment in trial ARGX-113-2006, but cannot complete a Treatment Period (TP) and the required Intertreatment Period (IP) visits within the ARGX-113-2006 trial's timeframe. 2. Either the participant or the participant's legally authorized representative can understand the requirements of the trial and provide written informed consent/assent, and willingness and ability to comply with the trial protocol procedures. 3. Contraceptive use for sexually active participants should be consistent with local regulations for those participating in clinical studies. A participant is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children. 1. Contraceptive requirements for male participants are presented in Section 10.4.2.2. 2. Female adolescents of childbearing potential (FAOCBP) must have a negative urine pregnancy test at trial entry (TP1V1 or IP0V1)

Exclusion Criteria:

Participants are excluded from the trial if any of the following criteria apply: 1. Female adolescents of childbearing potential (FAOCBP): Pregnancy or lactation, or the participant intends to become pregnant during their participation in the study. 2. Discontinued early from ARGX-113-2006 or ARGX-113-2207 treatment. 3. A known hypersensitivity reaction to efgartigimod or any of its excipients. 4. Any of the following medical conditions: 1. Clinically significant uncontrolled chronic bacterial, viral, or fungal infection at study entry not sufficiently resolved in the investigator's opinion. 2. Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of generalized myasthenia gravis (gMG) or put the participant at undue risk

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.

NCT05374590
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 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

argenx
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 Enrolling by invitation
Countries Belgium, France, Germany, Netherlands, Poland, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Generalized Myasthenia Gravis
Arms & Interventions

Arms

Experimental: Efgartigimod or Efgartigimod PH20 SC

Patients receiving Efgartigimod IV treatment or Efgartigimod PH 20 SC treatment

Interventions

Biological: - Efgartigimod IV or Efgartigimod PH20 SC

Intravenous infusion of Efgartigimod or Subcutaneous injection of Efgartigimod PH20 SC

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.

Chicago 4887398, Illinois 4896861

Status

Address

Ann and Robert H Lurie Children's Hospital of Chicago - Main Hospital

Chicago 4887398, Illinois 4896861, 60611

Charlottesville 4752031, Virginia 6254928

Status

Address

University of Virginia (UVA) Health - Developmental Pediatrics Clinic

Charlottesville 4752031, Virginia 6254928, 22903

International Sites

Universitair Ziekenhuis Antwerpen, Edegem 2799007, Belgium

Status

Address

Universitair Ziekenhuis Antwerpen

Edegem 2799007, , 2650

AP-HM- Hôpital de La Timone, Marseille 2995469, France

Status

Address

AP-HM- Hôpital de La Timone

Marseille 2995469, , 13005

Universitätsklinikum Essen, Essen 2928810, Germany

Status

Address

Universitätsklinikum Essen

Essen 2928810, , 45147

Leids Universitair Medisch Centrum, Leiden 2751773, Netherlands

Status

Address

Leids Universitair Medisch Centrum

Leiden 2751773, , 2333 ZA

Gdansk 3099434, Poland

Status

Address

Uniwersyteckie Centrum Kliniczne w Gdansku

Gdansk 3099434, , 80-211

Katowice 3096472, Poland

Status

Address

Wielospecjalistyczna Poradnia Lekarska Synapsis

Katowice 3096472, , 40-123

Warsaw 756135, Poland

Status

Address

Centralny Szpital Kliniczny - Uniwersyteckie Centrum Kliniczne WUM

Warsaw 756135, , 02-097

Valencia 2509954, Spain

Status

Address

Hospital Universitari i Politecnic La Fe de Valencia

Valencia 2509954, , 46026

London 2643743, United Kingdom

Status

Address

Great Ormand Street Hospital for Children NHS Foundation Trust - Great Ormond Street Hospital - Pediatric Neurology

London 2643743, , WC1N 3JH

Oxford 2640729, United Kingdom

Status

Address

Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital Children's Hospital

Oxford 2640729, , OX3 9DU

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