Active — Not RecruitingPhase 3

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

United States173 participantsStarted 2021-11-17

Plain-language summary

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

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 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.

✕. 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

Incidence, frequency, and severity of adverse events (AEs), AEs of special interest (AESIs), and serious AEs (SAEs)

Timeframe: 216 weeks

Vital sign measurement: blood pressure in the overall population

Timeframe: 216 weeks

ECG: PR, QT and QRS interval in the overall population

Timeframe: 216 weeks

Laboratory safety evaluations: CRP analysis in the overall population

Timeframe: 216 weeks

NCT IDNCT04812925

Sponsorargenx

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-01

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 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.

✕. 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

What they're measuring

Incidence, frequency, and severity of adverse events (AEs), AEs of special interest (AESIs), and serious AEs (SAEs)

Timeframe: 216 weeks

Vital sign measurement: blood pressure in the overall population

Timeframe: 216 weeks

ECG: PR, QT and QRS interval in the overall population

Timeframe: 216 weeks

Laboratory safety evaluations: CRP analysis in the overall population

Timeframe: 216 weeks