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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05374590

Studienbeginn:
August 2022

Letztes Update:
11.04.2024

Wirkstoff:
Efgartigimod IV or Efgartigimod PH20 SC

Indikation (Clinical Trials):
Myasthenia Gravis, Muscle Weakness

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
argenx

Collaborator:
-

Kontakt

Sabine Coppieters, MD
Kontakt:
Phone: 857-350-4834
E-Mail: ClinicalTrials@argenx.com» Kontaktdaten anzeigen

Studienlocations
(3 von 7)

Ann and Robert H. Lurie Childrens Hospital of Chicago
60611 Chicago
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Nancy Kuntz, MD
Phone: 857-350-4834
E-Mail: Clinicaltrials@argenx.com» Ansprechpartner anzeigen

University of Virginia
22903 Charlottesville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Anna Jesus, MD
Phone: 857-350-4834
E-Mail: Clinicaltrials@argenx.com» Ansprechpartner anzeigen

UZ Antwerpen
2650 Antwerp
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Diane Beysen, MD
Phone: 857-350-4834
E-Mail: Clinicaltrials@argenx.com» Ansprechpartner anzeigen

Leiden University Medical Center
2333 Leiden
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Erik Harmen Niks, MD
Phone: 8573504834
E-Mail: clinicaltrials@argenx.com» Ansprechpartner anzeigen

Wielospecjalistyczna Poradnia Lekarska Synapsis
40-123 Katowice
PolandRekrutierend» Google-Maps
Ansprechpartner:
Marek Smilowski, MD
Phone: 8573504834
E-Mail: clinicaltrials@argenx.com» Ansprechpartner anzeigen

Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny
02-097 Warszawa
PolandRekrutierend» Google-Maps
Ansprechpartner:
Anna Kostera-Pruszczyk, MD
Phone: 8573504834
E-Mail: clinicaltrials@argenx.com» Ansprechpartner anzeigen

Oxford University hospitals NHS Foundation Trust-Oxford Children's Hospital
OX3 9DU Oxford
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
Sithara Ramdas, MD
Phone: 857-350-4834
E-Mail: clinicaltrials@argenx.com» Ansprechpartner anzeigen

Alle anzeigen

Studien-Informationen

Brief Summary:

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Incidence of adverse events (AEs) (Time Frame - up to 4 years)

2. Severity of adverse events (AEs) (Time Frame - up to 4 years)

3. Incidence of serious adverse events (SAEs) (Time Frame - up to 4 years)

4. Severity of serious adverse events (SAEs) (Time Frame - up to 4 years)

5. Incidence of adverse events of special interest (AESIs) (Time Frame - up to 4 years)

6. Severity of adverse events of special interest (AESIs) (Time Frame - up to 4 years)

7. Changes in height from baseline (Time Frame - up to 4 years)

8. Changes in weight from baseline (Time Frame - up to 4 years)

9. Electrocardiogram - heart rate (Time Frame - up to 4 years)

10. Electrocardiogram - QTcF (ms) (Time Frame - up to 4 years)

Secondary outcome:

1. Incidence of antidrug antibodies (ADAs) against efgartigimod (Time Frame - up to 4 years)

2. Prevalence of antidrug antibodies (ADAs) against efgartigimod (Time Frame - up to 4 years)

3. Incidence of antibodies against recombinant human hyaluronidase PH20 (rHuPH20) (Time Frame - Up to 4 years)

4. Prevalence of antibodies against recombinant human hyaluronidase PH20 (rHuPH20) (Time Frame - Up to 4 years)

Geprüfte Regime

Efgartigimod IV or Efgartigimod PH20 SC:
Intravenous infusion of Efgartigimod or Subcutaneous injection of Efgartigimod PH20 SC

Quelle: ClinicalTrials.gov

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