← Back to Search

Monoclonal Antibodies

Efgartigimod for Immune Thrombocytopenic Purpura (advance NEXT Trial)

Phase 3
Recruiting
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights
Pivotal Trial

Summary

"This trial is looking at how effective and safe efgartigimod IV is for people with primary immune thrombocytopenia. Participants will be randomly assigned to receive either efgart

Who is the study for?
This trial is for adults with primary immune thrombocytopenia (ITP) who have low platelet counts and haven't responded well to previous treatments like steroids or immunoglobulins. Participants must be at least 18 years old, legally able to consent, and have had ITP for over a year.
What is being tested?
The study tests the effectiveness and safety of Efgartigimod IV compared to a placebo in treating ITP. Participants are randomly assigned to receive either the drug or placebo during an initial double-blind phase, followed by open-label phases where all get Efgartigimod IV.
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to Efgartigimod IV throughout the study periods including follow-up after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had immune thrombocytopenia for over a year.
Select...
I have been treated for ITP with steroids, IVIg, anti-D, TPO-RAs, or rituximab.
Select...
I've responded to ITP treatment with a platelet count increase before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Proportion of participants with an IWG response during the DBTP

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo IVExperimental Treatment2 Interventions
Participants receiving placebo IV during the double-blinded treatment period and receiving efgartigimod IV during the open-label treatment period(s)
Group II: Efgartigimod IVExperimental Treatment1 Intervention
Participants receiving efgartigimod IV during the double-blinded treatment period and the open-label treatment period(s)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efgartigimod IV
2023
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
72 Previous Clinical Trials
11,053 Total Patients Enrolled
~42 spots leftby Jun 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top