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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Efgartigimod IV (biological), Placebo IV (other)
How long the study runs: Study runs about 44 months (dates as stated)
About the drug or intervention: Efgartigimod IV — biological: Intravenous infusion of efgartigimod · Placebo IV — other: Intravenous infusion of placebo
Patient visit burden: Not specified by the sponsor

In plain English

This study is testing a medicine called efgartigimod, given through a drip into a vein (IV), in adults with primary immune thrombocytopenia (ITP). ITP is a condition where the immune system lowers platelets, the blood cells that help clotting. Researchers want to find out how well the medicine works and how safe it is. The study is funded by argenx.

Who can take part

Adults at least 18 years old (and old enough to legally consent to research where they live)
Platelet counts below 30 x 10^9/L on average before joining
Have had primary ITP for more than 12 months
Have tried at least one previous ITP treatment, such as steroids, IV immunoglobulin (IVIg), anti-D immunoglobulin, thrombopoietin receptor agonists (TPO-RAs), or rituximab
Previous treatments did not work well enough
Had at least one good platelet response (a platelet count of 50 × 10^9/L or more) to a previous ITP treatment within the past 3 years

Who may not be able to

Another autoimmune disease or other health problem that could affect the study results or put the person at extra risk
Secondary ITP (low platelets caused by another condition)
Low platelets not caused by the immune system
Autoimmune haemolytic anaemia (a condition where the immune system destroys red blood cells)
Severe or critical bleeding linked to ITP

What taking part involves

• Efgartigimod given into a vein through a drip (IV)

Time commitment: Not stated — ask the trial team about how long the study lasts, how many visits are needed, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 69
Started: 2024-10-18
Last checked: 2026-04

Plain English Summary

What is this study?

• Testing a new treatment for primary immune thrombocytopenia (itp)
• Phase3 - 69 participants
• 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)

Who can take part?

• Ages 18 Years and over
• Diagnosed with primary immune thrombocytopenia (itp)

Where?

• Birmingham - Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust
• Bradford - Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation
• Coventry - University Hospitals Coventry and Warwickshire NHS Trust
• Glasgow - Glasgow Royal Infirmary - North Glasgow University Hospital Division
• +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Primary Immune Thrombocytopenia (ITP)

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

What the study is looking for

✓Is at least 18 years of age and the local legal age of consent for clinical studies when signing the informed...
✓Has documented baseline mean blood clotting cell 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...
✓Has documented insufficient response to a prior ITP treatment (the specific criteria can be found in the protocol).

Who cannot take part

✗Secondary ITP
✗Nonimmune thrombocytopenia
✗Autoimmune hemolytic anemia
✗ITP-associated critical or severe bleeding The complete list of criteria can be found in the protocol.

See the 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.