Assessing the effects of efgartigimod IV in adults with primary immune thrombocytopenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of efgartigimod IV in adults diagnosed with primary immune thrombocytopenia (ITP). Participants will undergo a screening period followed by randomization to receive either efgartigimod IV or a placebo in a double-blinded manner. After a treatment period of up to 24 weeks, all participants will receive efgartigimod IV in an open-label phase lasting up to 52 weeks, with the possibility of an additional open-label treatment phase. The total duration of participation in the study may extend up to 138 weeks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Mayo Clinic Hospital Scottsdale
  Phoenix, Arizona, United States Recruiting
• University of Southern California Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• Sharp Memorial Hospital
  Oceanside, California, United States Recruiting
• University of Colorado Hospital
  Aurora, Colorado, United States Recruiting
• Yale University School of Medicine
  New Haven, Connecticut, United States Recruiting
• Georgetown University Hospital
  Washington D.C., District of Columbia, United States Recruiting

+44 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Sabine Coppieters, MD
• Email: Clinicaltrials@argenx.com
• Phone: 857-350-4834

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This trial tests whether adding orelabrutinib to high-dose dexamethasone helps adults newly diagnosed with primary ITP raise and maintain their platelet counts compared with placebo.

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• Intravenous immunoglobulin (5%) treatment for primary immune thrombocytopenia

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  Recruiting at 9 sites Phase 3 Grand Shuyang Life Sciences (Chengdu) Co., Ltd. · Ankara, Altındağ and 8 other locations · NCT07233213

• Romiplostim combined with glucocorticoids for treating newly diagnosed adult ITP

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  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT06992128

• Testing STSA-1301 injection for treating immune thrombocytopenia

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  Recruiting at 7 sites Phase 1/2 Jiangsu BioJeTay Biotechnology Co., Ltd. · Bengbu, Anhui and 6 other locations · NCT06929299

• Registry for patients with Primary Immune Thrombocytopenia in Spain

  This study is collecting information from patients with Primary Immune Thrombocytopenia in Spain to better understand the condition and improve how it's treated.

  Recruiting at 29 sites Fundación Española de Hematología y Hemoterapía · A Coruña, A Coruña and 35 other locations · NCT06919341

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.