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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 weeks, between visit 17 and 24 of the trial
Awards & highlights
ADVANCE+ Trial Summary
This trial will evaluate the efficacy and safety of ARGX-113 in adult patients with primary ITP.
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.Check my eligibility
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.See study design
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.
ADVANCE+ Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have completed a year-long treatment.
ADVANCE+ Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 weeks, between visit 17 and 24 of the trial
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 weeks, between visit 17 and 24 of the trial
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and severity of Adverse Events
Frequency and severity of laboratory assessments
Frequency and severity of vital signs
Secondary outcome measures
Change from baseline in Patient reported Outcomes (FACIT-Fatigue) at planned visits.
Change from baseline in Patient reported Outcomes (Fact-Th6) at planned visits.
Change from baseline in Quality of Life (SF-36) at planned visits.
+14 moreADVANCE+ 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
Find a Location
Who is running the clinical trial?
argenxLead Sponsor
60 Previous Clinical Trials
9,169 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has efgartigimod received approval from the FDA?
"Efgartigimod's safety is rated as a 3 because this medication has progressed to Phase 3 clinical trials. There is some data supporting efficacy and multiple rounds of data supporting safety."
Answered by AI
Have other researchers looked at this treatment before?
"efgartigimod's efficacy has been researched since 2020, with the first clinical trial being sponsored by argenx. The study concluded that efgartigimod was effective and it received Phase 3 drug approval in 2020. Currently, there are 4 live studies involving efgartigimod being conducted across 32 cities and 39 countries."
Answered by AI
In how many diverse locations is this trial conducted?
"There are 4 enrolling patients for this clinical trial such as Investigator Site 0010042 in Iowa City, Investigator Site 0010037 in Ocala, and Investigator Site 0010045 in Washington."
Answered by AI
Could you please share efgartigimod's clinical trial history?
"efgartigimod was first trialed in 2020 at Investigator Site 3800006. So far, 9 trials have concluded with 4 more currently underway - mostly centred in Iowa City, Iowa."
Answered by AI
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