A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
NCT ID: NCT04812925
Last Updated: 2026-01-12
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
PHASE3
173 participants
INTERVENTIONAL
2021-11-17
2026-10-01
Brief Summary
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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 receiving efgartigimod PH20 SC treatment
efgartigimod PH20 SC
Subcutaneous injection with efgartigimod PH20 SC
Interventions
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efgartigimod PH20 SC
Subcutaneous injection with efgartigimod PH20 SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants enrolled in the ARGX-113-2004 trial who completed the 24-week trial period.
Note: If a participant has had an SAE during the ARGX-113-2004 trial, their eligibility should be evaluated by the investigator and the sponsor's trial physician. The decision of enrolling the participant will be evaluated case by case.
3a. Agree to use contraceptives consistent with local regulations and the following:
• Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP.
In addition to the above criteria, for participants who want to continue receiving efgartigimod during an additional 52-week treatment period (only applicable in case efgartigimod is not yet commercially available for patients with primary ITP or available through another patient program for patients with primary ITP), the following criteria apply:
4\. Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits).
5\. Participant has completed a 52-week treatment period.
Exclusion Criteria
2. Use of any other investigational drug or participation in any other investigational trial
3. Known hypersensitivity reaction to efgartigimod PH20 SC or any of its excipients
4. Pregnant or lactating females and those who intend to become pregnant during the trial or within 90 days after last dose of efgartigimod PH20 SC
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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Investigator Site 0010116
Bentonville, Arkansas, United States
Investigator site 0010045
Washington D.C., District of Columbia, United States
Investigator Site 0010062
Fort Wayne, Indiana, United States
Investigator site US0010042
Iowa City, Iowa, United States
Investigator Site 0010095
Oklahoma City, Oklahoma, United States
Investigator Site 0540001
Buenos Aires, , Argentina
Investigator site 540004
Buenos Aires, , Argentina
Investigator Site 0610012
Garran, , Australia
Investigator Site 0610003
West Perth, , Australia
Investigator site 610005
Westmead, , Australia
Investigator Site 3590017
Plovdiv, , Bulgaria
Investigator site 0560003
Reñaca, , Chile
Investigator site 560002
Santiago, , Chile
Investigator site 0560004
Temuco, , Chile
Investigator site 860013
Beijing, , China
Investigator Site 0860008
Bengbu, , China
Investigator site 860055
Huizhou, , China
Investigator Site 0860015
Shenzhen, , China
Investigator Site 0860001
Tianjin, , China
Investigator Site 0860010
Wuhan, , China
Investigator Site 0860002
Wuxi, , China
Investigator Site 0860011
Zhengzhou, , China
Investigator site 860058
Zhenjiang, , China
Investigator Site 9950007
Tbilisi, , Georgia
Investigator site 9950009
Tbilisi, , Georgia
Investigator site 9950011
Tbilisi, , Georgia
Investigator site 300008
Athens, , Greece
Investigator Site 0300009
Thessaloniki, , Greece
Investigator site 3530003
Dublin, , Ireland
Investigator site 390043
Ferrara, , Italy
Investigator Site 0390032
Milan, , Italy
Investigator Site 0390044
Napoli, , Italy
Investigator site 390041
Napoli, , Italy
Investigator site JP0810015
Hirakata, , Japan
Investigator Site 0810017
Iruma, , Japan
Investigator Site 0810053
Kanagawa, , Japan
Investigator Site 0810051
Kitakyushu, , Japan
Investigator site 0810016
Shibukawa, , Japan
Investigator site 810023
Shimotsuke, , Japan
Investigator Site 0810038
Tama, , Japan
Investigator site 9620001
Irbid, , Jordan
Investigator site 520002
Aguascalientes, , Mexico
Investigator site 640005
Christchurch, , New Zealand
Investigator site 0470003
Sarpsborg, , Norway
Investigator site PL0480013
Katowice, , Poland
Investigator Site 0480026
Nowy Sącz, , Poland
Investigator Site 0480037
Skorzewo, , Poland
Investigator Site 3510007
Lisbon, , Portugal
Investigator site 3510004
Porto, , Portugal
Investigator site 3510001
Vila Nova de Gaia, , Portugal
Investigator Site 0400005
Bucharest, , Romania
Investigator site 400012
Bucharest, , Romania
Investigator Site 0400007
Craiova, , Romania
Investigator site 0070040
Kirov, , Russia
Investigator Site 0070026
Moscow, , Russia
Investigator Site 0070038
Nizhny Novgorod, , Russia
Investigator Site 0070037
Novosibirsk, , Russia
Investigator site 270003
Johannesburg, , South Africa
Investigator site 270004
Observatory, , South Africa
Investigator site 270001
Pretoria, , South Africa
Investigator site 270002
Randburg, , South Africa
Investigator site 820004
Seoul, , South Korea
Investigator site KO0820007
Seoul, , South Korea
Investigator Site 0660002
Bangkok, , Thailand
Investigator Site 0660003
Bangkok, , Thailand
Investigator site 660005
Bangkok, , Thailand
Investigator Site 0660001
Bangkok Noi, , Thailand
Investigator site 0660004
Chiang Mai, , Thailand
Investigator site TH0660009
Khon Kaen, , Thailand
Investigator site 2610001
Sousse, , Tunisia
Investigator site 2160002
Tunis, , Tunisia
Investigator Site 0900007
Adapazarı, , Turkey (Türkiye)
Investigator Site 0900003
Ankara, , Turkey (Türkiye)
Investigator Site 0900008
Ankara, , Turkey (Türkiye)
Investigator Site 0900015
Ankara, , Turkey (Türkiye)
Investigator site 900004
Izmir, , Turkey (Türkiye)
Investigator Site 0900014
Kocaeli, , Turkey (Türkiye)
Investigator site 900010
Mersin, , Turkey (Türkiye)
Investigator site 0900017
Tekirdağ, , Turkey (Türkiye)
Investigator site 900019
Trabzon, , Turkey (Türkiye)
Investigator site 440005
Coventry, , United Kingdom
Investigator site UK044041
London, , United Kingdom
Investigator site UK0440014
Penzance, , United Kingdom
Countries
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Other Identifiers
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ARGX-113-2005
Identifier Type: -
Identifier Source: org_study_id
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