Phase
Condition
Polymyositis (Inflammatory Muscle Disease)
Neuropathy
Myasthenia Gravis Generalised
Treatment
Efgartigimod IV or Efgartigimod PH20 SC
Efgartigimod IV
Clinical Study ID
Ages 2-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants are eligible to be included in the trial only if all of the following criteria apply:
The participant completed ARGX-113-2006 or ARGX-113-2207, defined as:
The participant reached End of Trial in trial ARGX-113-2006 or End of Study inARGX-113-2207 and agreed to participate in the ARGX-113-2008 trial.
The participant qualifies for retreatment in trial ARGX-113-2006, but cannotcomplete a Treatment Period (TP) and the required Intertreatment Period (IP)visits within the ARGX-113-2006 trial's timeframe.
Either the participant or the participant's legally authorized representative canunderstand the requirements of the trial and provide written informedconsent/assent, and willingness and ability to comply with the trial protocolprocedures.
Contraceptive use for sexually active participants should be consistent with localregulations for those participating in clinical studies. A participant is ofchildbearing potential if, in the opinion of the investigator, he/she isbiologically capable of having children.
Contraceptive requirements for male participants are presented in Section 10.4.2.2.
Female adolescents of childbearing potential (FAOCBP) must have a negativeurine pregnancy test at trial entry (TP1V1 or IP0V1)
Exclusion
Exclusion Criteria:
Participants are excluded from the trial if any of the following criteria apply:
Female adolescents of childbearing potential (FAOCBP): Pregnancy or lactation, orthe participant intends to become pregnant during their participation in the study.
Discontinued early from ARGX-113-2006 or ARGX-113-2207 treatment.
A known hypersensitivity reaction to efgartigimod or any of its excipients.
Any of the following medical conditions:
Clinically significant uncontrolled chronic bacterial, viral, or fungalinfection at study entry not sufficiently resolved in the investigator'sopinion.
Known autoimmune disease or any medical condition that would interfere with anaccurate assessment of clinical symptoms of generalized myasthenia gravis (gMG)or put the participant at undue risk
Study Design
Connect with a study center
Investigator site AT430010
Vienna, 1060
AustriaSite Not Available
Investigator site BE320021
Antwerp, 2650
BelgiumActive - Recruiting
UZ Antwerpen
Antwerp, 2650
BelgiumSite Not Available
Universitair Ziekenhuis Antwerpen
Edegem, 2650
BelgiumSite Not Available
AP-HM- Hôpital de La Timone
Marseille, 13385
FranceSite Not Available
Investigator site FR330032
Marseille, 13005
FranceSite Not Available
Investigator site FR330041
Paris, 75015
FranceSite Not Available
Investigator site GE9950017
Tbilisi, 0177
GeorgiaSite Not Available
Investigator site GE9950018
Tbilisi, 0186
GeorgiaActive - Recruiting
Investigator site DE0490034
Berlin, 13353
GermanySite Not Available
Investigator site DU490032
Essen, 45147
GermanySite Not Available
Investigator site IT390047
Florence, 50139
ItalySite Not Available
Investigator site IT390048
Genova, 16147
ItalySite Not Available
Investigator Site 03 - NL0310001
Leiden, 2333
NetherlandsActive - Recruiting
Investigator Site NL0310001
Leiden, 2333
NetherlandsActive - Recruiting
Leiden University Medical Center
Leiden, 2333
NetherlandsActive - Recruiting
Leids Universitair Medisch Centrum
Leiden, 2333 ZA
NetherlandsSite Not Available
Investigator site PL480035
Gdańsk, 80-952
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne w Gdansku
Gdańsk, 80-211
PolandSite Not Available
Investigator Site 02 - PL0480038
Katowice, 40-123
PolandActive - Recruiting
Investigator Site PL0480038
Katowice, 40-123
PolandActive - Recruiting
Wielospecjalistyczna Poradnia Lekarska Synapsis
Katowice, 40-123
PolandSite Not Available
Centralny Szpital Kliniczny - Uniwersyteckie Centrum Kliniczne WUM
Warszawa, 02-097
PolandSite Not Available
Investigator Site 01 - PL0480034
Warszawa, 02-097
PolandActive - Recruiting
Investigator Site PL0480034
Warszawa, 02-097
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny
Warszawa, 02-097
PolandActive - Recruiting
Investigator site ES340040
Barcelona, 08950
SpainSite Not Available
Investigator site ES340041
Valencia, 46026
SpainSite Not Available
Great Ormand Street Hospital for Children NHS Foundation Trust - Great Ormond Street Hospital - Pediatric Neurology
London, WC1N 3JH
United KingdomSite Not Available
Investigator site GB440035
London, WC1N 3JH
United KingdomSite Not Available
Investigator site UK0440027
Manchester, M13 9WL
United KingdomSite Not Available
Investigator site GB440024
Oxford, OX3 0AG
United KingdomActive - Recruiting
Investigator site UK0440024
Oxford, OX3 9DU
United KingdomActive - Recruiting
Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital Children's Hospital
Oxford, OX3 9DU
United KingdomSite Not Available
Oxford University hospitals NHS Foundation Trust-Oxford Children's Hospital
Oxford, OX3 9DU
United KingdomActive - Recruiting
Ann and Robert H Lurie Children's Hospital of Chicago - Main Hospital
Chicago, Illinois 60611
United StatesSite Not Available
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois 60611
United StatesActive - Recruiting
Investigator site US10120
Chicago, Illinois 60611
United StatesActive - Recruiting
Investigator site US10003
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Investigator site US10142
Charlottesville, Virginia 22903
United StatesActive - Recruiting
University of Virginia
Charlottesville, Virginia 22903
United StatesActive - Recruiting
University of Virginia (UVA) Health - Developmental Pediatrics Clinic
Charlottesville, Virginia 22903
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.