efgartigimod PH20 SC: Subcutaneous injection with efgartigimod PH20 SC
Study summary
A Phase 3 study to evaluate the safety and efficacy of efgartigimod PH20 subcutaneous in adult patients with primary immune thrombocytopenia
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Ability to understand the requirements of the trial and provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the trial protocol procedures (including attending the required trial visits).
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:
1. Introduction or continuation of nonpermitted medications during the ARGX-113-2004 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins, or live/live-attenuated vaccines)
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
Primary outcome measure(s)
Incidence, frequency, and severity of adverse events (AEs), AEs of special interest (AESIs), and serious AEs (SAEs) — 216 weeks
Vital sign measurement: blood pressure in the overall population — 216 weeks
ECG: PR, QT and QRS interval in the overall population — 216 weeks
Laboratory safety evaluations: CRP analysis in the overall population — 216 weeks
Trial sites (83)
Facility
City
Region
Status
Investigator Site 0010116
Bentonville
Arkansas
Investigator site 0010045
Washington D.C.
District of Columbia
Investigator Site 0010062
Fort Wayne
Indiana
Investigator site US0010042
Iowa City
Iowa
Investigator Site 0010095
Oklahoma City
Oklahoma
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
Naples
Italy
Investigator site 390041
Naples
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
+ 43 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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