A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).

Completed · Phase 3

Conditions studied: Primary Immune Thrombocytopenia

In brief

This is an open-label long-term multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in adult patients with primary ITP.

Key facts

Study ID

NCT04225156

Run by

argenx

People needed

101

Starts

2020-06-02

Expected to finish

2026-03-11

Last updated by the study team

2026-03-16

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, 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).
• Patients enrolled in the ARGX-113-1801 trial who completed the 24-weeks trial period.
• Women of childbearing potential must have a negative urine pregnancy test at baseline before trial medication (infusion) can be administered.
• Women of childbearing potential should use a highly effective or acceptable method of contraception during the trial and for 90 days after the last administration of the IMP. They must be on a stable regimen, for at least 1 month (as listed in the protocol)
• 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).
• Patient has completed a 52-week treatment period.

You may not qualify if…

• Introduction or continuation of non-permitted medications during the ARGX-113-1801 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins or live/live-attenuated vaccines).
• Pregnant or lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing.
• Patients with known medical history of hypersensitivity to any of the ingredients of efgartigimod.
• Use of any other investigational drug or participation in any other investigational trial.

Where it is running

• Investigator Site 0010037 — Ocala, Florida, United States
• Investigator Site 0010042 — Iowa City, Iowa, United States
• Investigator Site 0010040 — Columbus, Ohio, United States
• Investigator Site 0430002 — Vienna, Austria
• Investigator Site 0430003 — Vienna, Austria
• Investigator Site 0320012 — Brasschaat, Belgium
• Investigator Site 0320011 — Bruges, Belgium
• Investigator Site 0320014 — Turnhout, Belgium
• Investigator Site 0320002 — Yvoir, Belgium
• Investigator Site 3590001 — Pleven, Bulgaria
• Investigator Site 3590002 — Sofia, Bulgaria
• Investigator Site 4200001 — Brno, Czechia
• Investigator Site 4200008 — Olomouc, Czechia
• Investigator Site 4200006 — Ostrava, Czechia
• Investigator Site 4200007 — Prague, Czechia
• Investigator Site 0330009 — Créteil, France
• Investigator Site 0330018 — Montpellier, France
• Investigator Site 0330008 — Pessac, France
• Investigator Site 0330016 — Périgueux, France
• Investigator site 9950007 — Tbilisi, Georgia
• Investigator site 9950008 — Tbilisi, Georgia
• Investigator site 9950009 — Tbilisi, Georgia
• Investigator site 9950011 — Tbilisi, Georgia
• Investigator site 9950012 — Tbilisi, Georgia
• Investigator Site 0010045 — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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