A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
Key facts
- Who runs it
- argenx
- Where
- Bentonville, Fort Wayne, Iowa City, Oklahoma City, and Washington D.C., United StatesSee the 5 sitesAlso in 24 other countries, 73 sites
- Status
- Active, not recruiting
- Phase
- Phase 3
- People taking part
- 173 people enrolled
- Started
- 17 Nov 2021
- Expected to end
- Oct 2027
- Type of study
- Interventional
- Treatments tested
- efgartigimod PH20 SC
- Record updated
- 19 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
- Agree to use contraceptives consistent with local regulations
- In addition to the above criteria, for participants who want to continue receiving efgartigimod during an additional 52-week treatment period, the participant has completed a 52-week treatment period
Who cannot take part
- 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 in United States
Also in 24 other countries, 73 sites
- Bentonville, ArkansasHospital not named in the registryNo longer taking part
- Fort Wayne, IndianaHospital not named in the registryNo longer taking part
- Iowa City, IowaHospital not named in the registryNo longer taking part
- Oklahoma City, OklahomaHospital not named in the registryNo longer taking part
- Washington D.C., District of ColumbiaHospital not named in the registryNo longer taking part
About the trial
What the trial wants to find out
The main aim of the study is to evaluate the safety and efficacy of efgartigimod PH20 SC (subcutaneous) in adult patients with primary immune thrombocytopenia (ITP). Participants who completed the 24-week trial period of the ARGX- 113-2004 trial are given the opportunity to enter into this open-label extension trial and receive efgartigimod PH20 SC.
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Participants will be offered the opportunity to continue in this trial if they have completed the first 52-week treatment period unless efgartigimod becomes commercially available for patients with primary ITP or becomes available through another program for patients with primary ITP, whichever comes first. A maximum of three additional 52-week treatment periods will be offered to the participant to continue this trial.
The total trial duration per participant is up to 4 years (52-week treatment period, extendable with three additional 52-week treatment periods) + 8 weeks follow-up period.
The group in the trial
- efgartigimod PH20 SCTreatment being tested
Patients receiving efgartigimod PH20 SC treatment
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
- Record updated
- 19 October 2026