A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
NCT ID: NCT04280718
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
229 participants
INTERVENTIONAL
2020-09-18
2027-04-30
Brief Summary
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Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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efgartigimod PH20 SC
Patients treated with efgartigimod PH20 SC
Efgartigimod PH20 SC
Subcutaneous administration of efgartigimod
Interventions
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Efgartigimod PH20 SC
Subcutaneous administration of efgartigimod
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female patient with one of the following options:
* Have completed the Week-48 visit of Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC; or
* Have deteriorated during Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC, or
* Have been offered the participation in the OLE trial due to early termination of the ARGX-113-1802 trial (because sufficient events for the primary endpoint analysis of the that trial have been reached and it is stopped) and are considered to be eligible for treatment with efgartigimod PH20 SC treatment; or
* Have completed the Week-48 visit of the previous cycle of the OLE trial and are considered to be eligible to continue with efgartigimod PH20 SC treatment.
3. Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration.
4. Women of childbearing potential must use an acceptable method of contraception from signing the ICF until the date of the last administration of IMP.
Exclusion Criteria
2. Pregnant and lactating women and those intending to become pregnant during the trial.
3. Patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or patients who (intend to) use prohibited medications (see protocol) and therapies during the trial, or any other reason which could confound the results of the trial or put the patient at undue risk.
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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Investigator site 0010065
Birmingham, Alabama, United States
Investigator site 0010013
Phoenix, Arizona, United States
Investigator site 0010055
Scottsdale, Arizona, United States
Investigator site 0010032
Carlsbad, California, United States
Investigator site 10190
Pomona, California, United States
Investigator site 0010160
Rancho Mirage, California, United States
Investigator site 0010071
San Francisco, California, United States
Investigator site 0010057
Centennial, Colorado, United States
Investigator site 0010072
Boca Raton, Florida, United States
Investigator site 0010144
Coral Springs, Florida, United States
Investigator site 0010023
Jacksonville, Florida, United States
Investigator site 0010068
Maitland, Florida, United States
Investigator site 0010059
Miami, Florida, United States
Investigator site 0010006
Tampa, Florida, United States
Investigator site 0010011
Iowa City, Iowa, United States
Investigator site 0010015
Fairway, Kansas, United States
Investigator site 10147
Lexington, Kentucky, United States
Investigator site 10168
New York, New York, United States
Investigator site 0010003
Chapel Hill, North Carolina, United States
Investigator site 0010064
Columbus, Ohio, United States
Investigator site 0010007
Philadelphia, Pennsylvania, United States
Investigator site 0010047
Philadelphia, Pennsylvania, United States
Investigator Site 0010066
Austin, Texas, United States
Investigator site 0010009
San Antonio, Texas, United States
Investigator site 0010061
Richmond, Virginia, United States
Investigator site 0430007
Innsbruck, , Austria
Investigator site 0430008
Linz, , Austria
Investigator site 0430005
Vienna, , Austria
Investigator site 0320016
Edegem, , Belgium
Investigator site 0320009
Leuven, , Belgium
Investigator site 320024
Liège, , Belgium
Investigator site 320022
Woluwe-Saint-Lambert, , Belgium
Investigator site 3590007
Pleven, , Bulgaria
Investigator site 3590005
Sofia, , Bulgaria
Investigator site 3590008
Sofia, , Bulgaria
Investigator site 3590006
Sofia, , Bulgaria
Investigator site 0860033
Beijing, , China
Investigator site 860041
Changsha, , China
Investigator site 0860036
Chengdu, , China
Investigator site 860049
Chifeng, , China
Investigator site 0860038
Fuzhou, , China
Investigator site 0860050
Guangzhou, , China
Investigator site 0860032
Guanzhou, , China
Investigator site 0860045
Guiyang, , China
Investigator site 0860035
Hangzhou, , China
Investigator site 0860031
Jinan, , China
Investigator site 0860040
Nanchang, , China
Investigator site 0860043
Nanjing, , China
Investigator site 0860028
Shanghai, , China
Investigator site 860047
Shanghai, , China
Investigator site 0860042
Tianjin, , China
Investigator site 0860034
Wuhan, , China
Investigator site 0860029
Wuhan, , China
Investigator site 0860048
Xi'an, , China
Investigator site 0860054
Xianyang, , China
Investigator site 4200010
Hradec Králové, , Czechia
Investigator site 0450002
Aarhus, , Denmark
Investigator site 0450001
Copenhagen, , Denmark
Investigator site 0450003
Odense, , Denmark
Investigator site 00330034
Angers, , France
Investigator site 0330013
Bordeaux, , France
Investigator site 330033
Clermont-Ferrand, , France
Investigator site 0330023
Le Kremlin-Bicêtre, , France
Investigator site 0330024
Limoges, , France
Investigator site 330022
Nantes, , France
Investigator site 0330021
Nice, , France
Investigator site 0330035
Paris, , France
Investigator site 0330020
Strasbourg, , France
Investigator site 9950020
Kutaisi, , Georgia
Investigator site 9950004
Tbilisi, , Georgia
Investigator site 9950005
Tbilisi, , Georgia
Investigator site 9950002
Tbilisi, , Georgia
Investigator Site 9950003
Tbilisi, , Georgia
Investigator site 490044
Bochum, , Germany
Investigator site 0490013
Cologne, , Germany
Investigator site 490045
Essen, , Germany
Investigator site 490021
Göttingen, , Germany
Investigator site 0490016
Kiel, , Germany
Investigator site 0490019
Potsdam, , Germany
Investigator site 9720004
Tel Aviv, , Israel
Investigator site 0390022
Brescia, , Italy
Investigator site 390029
Florence, , Italy
Investigator site 0390024
Genova, , Italy
Investigator site 390027
Messina, , Italy
Investigator site 0390003
Milan, , Italy
Investigator site 0390026
Milan, , Italy
Investigator site 0390023
Pisa, , Italy
Investigator site 0390008
Roma, , Italy
Investigator site 0390042
Torino, , Italy
Investigator site 0810035
Bunkyō City, , Japan
Investigator site 0810002
Chiba, , Japan
Investigator site 0810030
Fuchū, , Japan
Investigator site 0810031
Fukuoka, , Japan
Investigator site 0810065
Ginowan, , Japan
Investigator site 0810066
Hakodate, , Japan
Investigator site 0810058
Hiroshima, , Japan
Investigator site 0810029
Kawagoe, , Japan
Investigator site 0810026
Kodaira, , Japan
Investigator site 810061
Kyoto, , Japan
Investigator site 0810027
Mibu, , Japan
Investigator site 0810032
Nagoya, , Japan
Investigator site 0810003
Osaka, , Japan
Investigator site 0810007
Osaka, , Japan
Investigator site 0810063
Suita, , Japan
Investigator site 0810036
tabashi City, , Japan
Investigator site 0810064
Tokushima, , Japan
Investigator site 0810060
Yokohama, , Japan
Investigator site 31
Riga, , Latvia
Investigator site 0310010
Amsterdam, , Netherlands
Investigator site 0310011
Rotterdam, , Netherlands
Investigator site 0480024
Krakow, , Poland
Investigator site 0480018
Krakow, , Poland
Investigator site 0480020
Lodz, , Poland
Investigator Site 0480017
Lublin, , Poland
Investigator site 0480022
Warsaw, , Poland
Investigator site 040002
Brasov, , Romania
Investigator site 040001
Bucharest, , Romania
Investigator site 040004
Constanța, , Romania
Investigator site 040003
Timișoara, , Romania
Investigator site 070017
Kazan', , Russia
Investigator site 0070023
Kazan', , Russia
Investigator site 0070020
Moscow, , Russia
Investigator site 70021
Moscow, , Russia
Investigator site 0070019
Rostov-on-Don, , Russia
Investigator site 0070014
Saint Petersburg, , Russia
Investigator site 0070021
Saransk, , Russia
Investigator site 3810001
Belgrade, , Serbia
Investigator site 3810003
Belgrade, , Serbia
Investigator site 3810004
Kragujevac, , Serbia
Investigator site 0340021
Badalona, , Spain
Investigator site 0340038
Barcelona, , Spain
Investigator site 0340018
Madrid, , Spain
Investigator site 8860013
Tainan City, , Taiwan
Investigator site 8860012
Taipei, , Taiwan
Investigator site 8860016
Taipei, , Taiwan
Investigator site 8860017
Taoyuan District, , Taiwan
Investigator site 900025
Bursa, , Turkey (Türkiye)
Investigator site 900021
Izmir, , Turkey (Türkiye)
Investigator site 900022
Samsun, , Turkey (Türkiye)
Investigator Site 3800012
Dnipro, , Ukraine
Investigator Site 3800010
Ivano-Frankivsk, , Ukraine
Investigator site 3100013
Kyiv, , Ukraine
Investigator site 3800008
Lutsk, , Ukraine
Investigator site 3800011
Zaporizhzhya, , Ukraine
Investigator site 440026
London, , United Kingdom
Investigator site 0440016
Oxford, , United Kingdom
Investigator site 0440018
Sheffield, , United Kingdom
Countries
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Other Identifiers
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2019-003107-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ARGX-113-1902
Identifier Type: -
Identifier Source: org_study_id
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