CompletedPhase 3

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

United States, Austria101 participantsStarted 2020-06-02

Plain-language summary

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.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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.

Frequency and severity of Adverse Events

Timeframe: Up to 60 weeks

Frequency and severity of vital signs

Timeframe: Up to 60 weeks

Frequency and severity of laboratory assessments

Timeframe: Up to 60 weeks

NCT IDNCT04225156

Sponsorargenx

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-11

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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.