Phase
Condition
Neuropathy
Myasthenia Gravis Generalised
Polymyositis (Inflammatory Muscle Disease)
Treatment
efgartigimod PH20 SC
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must be capable of giving signed informed consent, which includes compliance withthe requirements and restrictions listed in the informed consent form (ICF) and inthis protocol.
Previously participated in antecedent studies ARGX-113-2001 or ARGX-113-1705 and areeligible for roll over.
Contraceptive use by men and women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studiesand:
- Women of Child bearing potential (WOCBP) must have a negative urine pregnancytest at baseline before investigational medicinal product (IMP) can beadministered.
Exclusion
Exclusion Criteria:
The participant was discontinued early from studies ARGX-113-2001 or ARGX-113-1705,unless the reason for discontinuation from study ARGX-113-1705 was to roll over intostudy ARGX-113-2002. a. Participants who, in the investigator's judgment, are not benefiting fromefgartigimod IV in study ARGX-113-1705 Part B are not eligible for roll over intoARGX-113-2002.
Are pregnant or lactating, or intend to become pregnant during the study or within 90 days after the last dose of investigational medicinal product (IMP)
Has any of the following medical conditions:
Clinically significant uncontrolled chronic bacterial, viral, or fungalinfection at roll-over
Any other known autoimmune disease that, in the opinion of the investigator,would interfere with accurate assessment of clinical symptoms of myastheniagravis or put the participant at undue risk
History of malignancy unless deemed cured by adequate treatment with noevidence of reoccurrence for ≥3 years before the first administration ofinvestigational medicinal product (IMP).Participants with the following cancers can be included at any time:
- adequately treated basal cell or squamous cell skin cancer
- carcinoma in situ of the cervix
- carcinoma in situ of the breast
- incidental histological findings of prostate cancer (TNM classification ofmalignant tumors stage T1a or T1b)
Clinical evidence of other significant serious diseases, or the participant hashad a recent major surgery, or who have any other condition that, in theopinion of the investigator, could confound the results of the study or put theparticipant at undue risk
Received a live-attenuated vaccine within 28 days prior to study entry or plan toreceive a live-attenuated vaccine during the study
A known hypersensitivity reaction to efgartigimod, rHuPH20, or any of its excipients
Study Design
Connect with a study center
Investigator site 5 - BE0320007
Gent, 9000
BelgiumSite Not Available
Investigator site 5 - BE0320007
Ghent 2797656, 9000
BelgiumSite Not Available
Investigator site 24 - CZ4200005
Brno, 625 00
CzechiaSite Not Available
Investigator site 24 - CZ4200005
Brno 3078610, 625 00
CzechiaSite Not Available
Investigator Site 32 - GEO9950004
Tbilisi 611717, K'alak'i T'bilisi 611716 0160
GeorgiaSite Not Available
Investigator Site 33 - GEO9950016
Tbilisi 611717, K'alak'i T'bilisi 611716 016
GeorgiaSite Not Available
Investigator Site 1 - GEO9950001
Tbilisi, 0114
GeorgiaSite Not Available
Investigator Site 32 - GEO9950004
Tbilisi, 0160
GeorgiaSite Not Available
Investigator Site 33 - GEO9950016
Tbilisi, 016
GeorgiaSite Not Available
Investigator site 2 - GEO9950002
Tbilisi, 0112
GeorgiaSite Not Available
Investigator site 3 - GEO9950003
Tbilisi, 0114
GeorgiaSite Not Available
Investigator Site 1 - GEO9950001
Tbilisi 611717, 0114
GeorgiaSite Not Available
Investigator site 2 - GEO9950002
Tbilisi 611717, 0112
GeorgiaSite Not Available
Investigator site 3 - GEO9950003
Tbilisi 611717, 0114
GeorgiaSite Not Available
Investigator Site 25 - DE490006
Berlin, 10117
GermanySite Not Available
Investigator Site 25 - DE490006
Berlin 2950159, 10117
GermanySite Not Available
Investigator Site 26 - DE490009
Münster, 48149
GermanySite Not Available
Investigator Site 26 - DE490009
Münster 2867543, 48149
GermanySite Not Available
Investigator site 10 - HU0360013
Budapest, 1082
HungarySite Not Available
Investigator site 9 - HU0360012
Budapest, 1204
HungarySite Not Available
Investigator site 10 - HU0360013
Budapest 3054643, 1082
HungarySite Not Available
Investigator site 9 - HU0360012
Budapest 3054643, 1204
HungarySite Not Available
Investigator site 11 - IT0390003
Milan 6951411, 20133
ItalySite Not Available
Investigator site 11 - IT0390003
Milano, 20133
ItalySite Not Available
Investigator Site 34 - IT0390007
Napoli, 80138
ItalySite Not Available
Investigator Site 34 - IT0390007
Napoli 9031661, 80138
ItalySite Not Available
Investigator Site 35 - IT0390008
Roma, 00189
ItalySite Not Available
Investigator Site 35 - IT0390008
Roma 8957247, 00189
ItalySite Not Available
Investigator site 12 - JP0810002
Chiba, Chiba-Shi 260-8677
JapanSite Not Available
Investigator site 12 - JP0810002
Chiba 2113015, Chiba-Shi 260-8677
JapanSite Not Available
Investigator Site 36 - JP0810055
Sapporo, Hokkaido 063-0005
JapanSite Not Available
Investigator Site 36 - JP0810055
Sapporo 2128295, Hokkaido 2130037 063-0005
JapanSite Not Available
Investigator site 8 - JP0810004
Hanamaki, Iwate 025-0082
JapanSite Not Available
Investigator site 8 - JP0810004
Hanamaki 2112823, Iwate 2112518 025-0082
JapanSite Not Available
Investigator Site 28- JP0810059
Ota-Ku, Tokyo 143-8541
JapanSite Not Available
Investigator Site 28- JP0810059
Ōta-ku 8469289, Tokyo 1850144 143-8541
JapanSite Not Available
Investigator site 14 - JP0810007
Osaka, 565-0871
JapanSite Not Available
Investigator site 14 - JP0810007
Osaka 1853909, 565-0871
JapanSite Not Available
Investigator Site 27 - JP0810008
Sapporo, 060 8542
JapanSite Not Available
Investigator Site 27 - JP0810008
Sapporo 2128295, 060 8542
JapanSite Not Available
Investigator site 13 - JP0810005
Sendai 2111149, 983-8520
JapanSite Not Available
Investigator site 13 - JP0810005
Sendai-shi, 983-8520
JapanSite Not Available
Investigator site 15 - JP0810009
Tokyo, 160-0023
JapanSite Not Available
Investigator site 15 - JP0810009
Tokyo 1850147, 160-0023
JapanSite Not Available
Investigator site 16 - NL0310001
Leiden, 2333
NetherlandsSite Not Available
Investigator site 16 - NL0310001
Leiden 2751773, 2333
NetherlandsSite Not Available
Investigator site 17 - PL0480001
Gdansk 3099434, 80-952
PolandSite Not Available
Investigator site 17 - PL0480001
Gdańsk, 80-952
PolandSite Not Available
Investigator site 19 - PL0480007
Katowice, 40-123
PolandSite Not Available
Investigator site 19 - PL0480007
Katowice 3096472, 40-123
PolandSite Not Available
Investigator site 18 - PL0480005
Krakow 3094802, 31-505
PolandSite Not Available
Investigator site 22 - PL0480065
Krakow 3094802, 31-426
PolandSite Not Available
Investigator site 18 - PL0480005
Kraków, 31-505
PolandSite Not Available
Investigator site 22 - PL0480065
Kraków, 31-426
PolandSite Not Available
Investigator site 20 - PL0480018
Lublin, 20-093
PolandSite Not Available
Investigator site 20 - PL0480018
Lublin 765876, 20-093
PolandSite Not Available
Investigator site 21 - PL0480022
Warsaw, 02-097
PolandSite Not Available
Investigator site 21 - PL0480022
Warsaw 756135, 02-097
PolandSite Not Available
Investigator Site 29- RU0070002
Novosibirsk 1496747, 630087
RussiaSite Not Available
Investigator Site 30 - RU0070014
Saint Petersburg 498817, 194354
RussiaSite Not Available
Investigator Site 29- RU0070002
Novosibirsk, 630087
Russian FederationSite Not Available
Investigator Site 30 - RU0070014
Saint Petersburg, 194354
Russian FederationSite Not Available
Investigator Site 31 - ES0340038
Barcelona, 08041
SpainSite Not Available
Investigator Site 37 - ES0340021
Barcelona, 08035
SpainSite Not Available
Investigator Site 31 - ES0340038
Barcelona 3128760, 08041
SpainSite Not Available
Investigator Site 37 - ES0340021
Barcelona 3128760, 08035
SpainSite Not Available
Investigator site 23 - ES0340039
Valencia, 46026
SpainSite Not Available
Investigator site 23 - ES0340039
Valencia 2509954, 46026
SpainSite Not Available
Investigator site 6 - US0010032
Carlsbad, California 92011
United StatesSite Not Available
Investigator Site 47 - US0010021
Palo Alto, California 94304
United StatesSite Not Available
Investigator site 6 - US0010032
Carlsbad 5334223, California 5332921 92011
United StatesSite Not Available
Investigator Site 47 - US0010021
Palo Alto 5380748, California 5332921 94304
United StatesSite Not Available
Investigator Site 45 - US0010108
Boca Raton, Florida 33428
United StatesSite Not Available
Investigator site 4 - US0010110
Port Charlotte, Florida 33952
United StatesSite Not Available
Investigator Site 39 - US0010006
Tampa, Florida 41076
United StatesSite Not Available
Investigator Site 45 - US0010108
Boca Raton 4148411, Florida 4155751 33428
United StatesSite Not Available
Investigator site 4 - US0010110
Port Charlotte 4169130, Florida 4155751 33952
United StatesSite Not Available
Investigator Site 39 - US0010006
Tampa 4174757, Florida 4155751 41076
United StatesSite Not Available
Investigator Site 41 - US0010015
Kansas City, Kansas 66160
United StatesSite Not Available
Investigator Site 41 - US0010015
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
Investigator Site 46 - US0010111
Amherst, New York 14226
United StatesSite Not Available
Investigator Site 46 - US0010111
Amherst 5107129, New York 5128638 14226
United StatesSite Not Available
Investigator Site 38 - US0010003
Chapel Hill, North Carolina 27514
United StatesSite Not Available
Investigator Site 44 - US0010077
Durham, North Carolina 27710
United StatesSite Not Available
Investigator Site 38 - US0010003
Chapel Hill 4460162, North Carolina 4482348 27514
United StatesSite Not Available
Investigator Site 44 - US0010077
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
Investigator Site 42 - US0010019
Cleveland, Ohio 44195
United StatesSite Not Available
Investigator Site 42 - US0010019
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
Investigator site 7 - US0010008
Cordova, Tennessee 38018
United StatesSite Not Available
Investigator site 7 - US0010008
Cordova 4050552, Tennessee 4662168 38018
United StatesSite Not Available
Investigator Site 43 - US0010066
Austin, Texas 78759
United StatesSite Not Available
Investigator Site 40 - US0010009
San Antonio, Texas 78229
United StatesSite Not Available
Investigator Site 43 - US0010066
Austin 4671654, Texas 4736286 78759
United StatesSite Not Available
Investigator Site 40 - US0010009
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available

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