A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia (NCT06544499)
A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Hospital Scottsdale — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (94 Sites)
Showing the first 25 of 94 sites.
- Mayo Clinic Hospital Scottsdale — Phoenix, Arizona
- University of Southern California Norris Comprehensive Cancer Center — Los Angeles, California
- Sharp Memorial Hospital — Oceanside, California
- University of Colorado Hospital — Aurora, Colorado
- Yale University School of Medicine — New Haven, Connecticut
- Georgetown University Hospital — Washington D.C., District of Columbia
- The University of Chicago Medicine — Chicago, Illinois
- The University of Iowa Hospitals & Clinics — Iowa City, Iowa
- Tulane University — New Orleans, Louisiana
- Henry Ford Health — Detroit, Michigan
- University of Minnesota — Minneapolis, Minnesota
- Regional Cancer Care Associates, LLC (RCCA) — Little Silver, New Jersey
- Clinical Research Alliance Inc. — Westbury, New York
- Duke University Medical Center — Durham, North Carolina
- Brody School of Medicine at East Carolina University — Greenville, North Carolina
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Ohio State University Hospital East — Columbus, Ohio
- INTEGRIS Cancer Institute of Oklahoma — Oklahoma City, Oklahoma
- Allgemeines Krankenhaus der Stadt Linz — Linz,
- Ordensklinikum Linz GmbH Elisabethinen — Linz,
- Klinikum Kreuzschwestern Wels — Wels,
- Acibadem City clinic Tokuda hospital — Sofia,
- UMHAT Aleksandrovska — Sofia,
- University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski — Sofia,
- National Specialized Hospital for Active Treatment of Hematology Diseases — Sofia,
📞 Contact the Study Coordinator
Phone: (857) 350-4834
Email: Clinicaltrials@argenx.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Primary Immune Thrombocytopenia (ITP)
- Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP) — Yuma, Arizona
- A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies — Boston, Massachusetts
- A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP) — Fayetteville, Arkansas
Explore by condition: All Primary Immune Thrombocytopenia (ITP) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.