Status:
ACTIVE_NOT_RECRUITING
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients with Primary Immune Thrombocytopenia
Lead Sponsor:
argenx
Conditions:
Primary Immune Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A Phase 3 study to evaluate the safety and efficacy of efgartigimod PH20 subcutaneous in adult patients with primary immune thrombocytopenia
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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:
- 4\. 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).
- 5\. Participant has completed a 52-week treatment period.
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
November 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2026
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT04812925
Start Date
November 17 2021
End Date
October 1 2026
Last Update
December 4 2024
Active Locations (83)
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1
Investigator Site 0010116
Bentonville, Arkansas, United States, 72758
2
Investigator site 0010045
Washington D.C., District of Columbia, United States, 20007
3
Investigator Site 0010062
Fort Wayne, Indiana, United States, 46804
4
Investigator site US0010042
Iowa City, Iowa, United States, 52242