A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

Running, not enrolling · Phase 3

Conditions studied: Primary Immune Thrombocytopenia

In brief

A Phase 3 study to evaluate the safety and efficacy of efgartigimod PH20 subcutaneous in adult patients with primary immune thrombocytopenia

Key facts

Study ID

NCT04812925

Run by

argenx

People needed

173

Starts

2021-11-17

Expected to finish

2026-10-01

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• 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:
• 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).
• Participant has completed a 52-week treatment period.

You may not qualify if…

• 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)
• Use of any other investigational drug or participation in any other investigational trial
• Known hypersensitivity reaction to efgartigimod PH20 SC or any of its excipients
• 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

Where it is running

• 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 0010116 — Bentonville, Arkansas, United States

Full record on ClinicalTrials.gov

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