Status:
RECRUITING
A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
Lead Sponsor:
argenx
Conditions:
Primary Immune Thrombocytopenia (ITP)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main purpose of this study is to look at the effect (efficacy) and safety of efgartigimod IV in participants with primary immune thrombocytopenia (ITP). After an up to 2 weeks screening period, el...
Eligibility Criteria
Inclusion
- Is at least 18 years of age and the local legal age of consent for clinical studies when signing the informed consent form (ICF).
- Has documented baseline mean platelet count of \<30 x 10\^9/L before randomization
- Has a documented duration of primary immune thrombocytopenia (ITP) of more than 12 months on the date of informed consent form (ICF) signature.
- Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, intravenous immunoglobulin (IVIg), anti-D immunoglobulin, thrombopoietin receptor agonist (TPO-RAs), or rituximab.
- Has documented insufficient response to a prior ITP treatment (the specific criteria can be found in the protocol).
- Has documented prior response defined as 1 platelet count of ≥50 × 109/L to at least 1 of the following ITP treatments in the 3 years before the date of ICF signature: prednisone, dexamethasone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin
Exclusion
- Other than the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of ITP, confound the results of the study or put the participant at undue risk.
- Secondary ITP
- Nonimmune thrombocytopenia
- Autoimmune hemolytic anemia
- ITP-associated critical or severe bleeding The complete list of criteria can be found in the protocol.
Key Trial Info
Start Date :
October 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06544499
Start Date
October 18 2024
End Date
June 1 2028
Last Update
January 8 2026
Active Locations (92)
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1
Mayo Clinic Hospital Scottsdale
Phoenix, Arizona, United States, 85054
2
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
Sharp Memorial Hospital
Oceanside, California, United States, 92056
4
University of Colorado Hospital
Aurora, Colorado, United States, 80045