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RecruitingPhase 3

A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia

argenx · NCT06544499

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
69
US sites recruiting
17
Study start
October 18, 2024
Record last updated
May 1, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV, respectively during the double-blinded treatment period (DBTP). At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first 52-week open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second 52-week OLTP2. After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks.

More information can be found here: https://clinicaltrials.argenx.com/advancenext

Being studied: Efgartigimod IV; Placebo IV

Conditions: Primary Immune Thrombocytopenia (ITP)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Mayo Clinic Hospital Scottsdale

    Phoenix, AZ 85054

    Site contact: Surbhi Shah, MD · 480-574-1853 · ramirez.alexandria@mayo.edu

  • University of Southern California Norris Comprehensive Cancer Center

    Los Angeles, CA 90033

    Site contact: Caroline I Piatek, MD · 323-865-0371 · duran_c@med.usc.edu

  • Sharp Memorial Hospital

    Oceanside, CA 92056

    Site contact: Catherine Quinn, MD · 760-272-4749 · Christina.Spencer@profoundresearch.com

  • University of Colorado Hospital

    Aurora, CO 80045

    Site contact: Gemlyn George, MD · 303-724-1513 · gianni.solis@cuanschutz.edu

  • Yale University School of Medicine

    New Haven, CT 06510

    Site contact: Yevgeniya Foster, MD · 203-623-5753 · loren.rodriguez@yale.edu

  • Georgetown University Hospital

    Washington D.C., DC 20007

    Site contact: Catherine Broome, MD · 202-687-0116 · js4936@georgetown.edu

  • The University of Chicago Medicine

    Chicago, IL 60637

    Site contact: Michael Drazer, MD · 773-834-9316 · antojean.xavior@bsd.uchicago.edu

  • The University of Iowa Hospitals & Clinics

    Iowa City, IA 52242

    Site contact: Steven Lentz, MD · 319-384-9643 · darby-donovan@uiowa.edu

  • Tulane University

    New Orleans, LA 70112

    Site contact: Maissaa Janbain, MD · 504-988-5433 · cscott@tulane.edu

  • Henry Ford Health

    Detroit, MI 48202

    Site contact: Vrushali Dabak, MD · 313-556-8729 · agopala7@hfhs.org

  • University of Minnesota

    Minneapolis, MN 55422

    Site contact: Marshall Mazepa, MD · 6126269520 · wrig1316@umn.edu

  • Regional Cancer Care Associates, LLC (RCCA)

    Little Silver, NJ 07739

    Site contact: Iuliana Shapira, MD · 732-530-8666 X 1430 · melanie.gonzalez@regionalcancercare.org

  • Duke University Medical Center

    Durham, NC 27710

    Site contact: Ara Metjian, MD · 919-681-2668 · kristin.byrne@duke.edu

  • Brody School of Medicine at East Carolina University

    Greenville, NC 27834

    Site contact: Darla Liles, MD · 252-744-3617 · wootenk16@ecu.edu

  • University Hospitals Cleveland Medical Center

    Cleveland, OH 44106

    Site contact: Koen van Besien, MD · 216-844-8123 · donna.kane1@uhhospitals.org

  • Ohio State University Hospital East

    Columbus, OH 43203

    Site contact: Marina Beltrami Moreira, MD · 614-293-5176 · Nives.Quaye@osumc.edu

  • INTEGRIS Cancer Institute of Oklahoma

    Oklahoma City, OK 73109

    Site contact: Bashar Alasad, MD · 405-636-7951 · kellie.larsen@integrishealth.org

Study contacts (from the official record)

  • Sabine Coppieters, MD · 857-350-4834 · Clinicaltrials@argenx.com
A Study to Assess the Efficacy and Safety of Efgartigimod IV in… (NCT06544499) | Bored Studies