← Back to Search

Monoclonal Antibodies

Efgartigimod for ITP (ADVANCE+ Trial)

Phase 3
Waitlist Available
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has completed a 52-week treatment period
Be older than 18 years old
Must not have
Introduction or continuation of non-permitted medications during the ARGX-113-1801 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins or live/live-attenuated vaccines)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing ARGX-113, a medication for adults with primary ITP, a condition where the immune system attacks platelets. The medication aims to calm the immune system to prevent it from attacking these important blood cells.

Who is the study for?
Adults with primary ITP, a condition causing low platelet count, can join this trial if they've completed prior phases. Women must use effective contraception and have a negative pregnancy test. Participants should understand the trial demands and not be on excluded medications or treatments.
What is being tested?
The study is testing Efgartigimod's long-term effectiveness and safety for treating primary ITP in adults. It's an open-label phase 3 trial where everyone receives the drug to see how well it works over time.
What are the potential side effects?
Possible side effects of Efgartigimod may include reactions at the infusion site, headaches, nausea, or allergic responses due to hypersensitivity to its ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have completed a year-long treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not taking any restricted medications like anti-CD20 therapy or live vaccines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups
Experimental Treatment
Group I: efgartigimodExperimental Treatment1 Intervention
patients receiving efgartigimod
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
efgartigimod
2019
Completed Phase 3
~140

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Thrombocytopenic Purpura (TP) work by either reducing the levels of pathogenic antibodies or increasing platelet production. Efgartigimod, for example, blocks the neonatal Fc receptor (FcRn) to reduce IgG antibody levels, which is important because these antibodies can destroy platelets. Corticosteroids suppress the immune system to lower antibody production, while thrombopoietin receptor agonists like eltrombopag stimulate the production of new platelets. These mechanisms are crucial for managing TP as they help to balance platelet destruction and production, thereby alleviating symptoms and improving patient outcomes.
Generation of two high affinity anti-mouse FcRn antibodies: Inhibition of IgG recycling in wild type mice and effect in a mouse model of immune thrombocytopenia.

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
67 Previous Clinical Trials
10,274 Total Patients Enrolled

Media Library

Efgartigimod (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04225156 — Phase 3
Thrombocytopenic Purpura Research Study Groups: efgartigimod
Thrombocytopenic Purpura Clinical Trial 2023: Efgartigimod Highlights & Side Effects. Trial Name: NCT04225156 — Phase 3
Efgartigimod (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04225156 — Phase 3
~33 spots leftby Nov 2026