Your session is about to expire
← 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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have completed a year-long treatment.I am not taking any restricted medications like anti-CD20 therapy or live vaccines.I completed the 24-week ARGX-113-1801 trial.I am using reliable birth control and have been for at least a month.You have a history of being very sensitive or allergic to any of the ingredients in efgartigimod.Women who could become pregnant must have a negative urine pregnancy test before starting the trial medication.
Research Study Groups:
This trial has the following groups:- Group 1: efgartigimod
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger