Efgartigimod for ITP
(ADVANCE+ Trial)

Recruiting in Palo Alto (17 mi)

+86 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: argenx

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I have completed a year-long treatment.

Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits)

I completed the 24-week ARGX-113-1801 trial.

+3 more

Exclusion Criteria

I am not taking any restricted medications like anti-CD20 therapy or live vaccines.

Use of any other investigational drug or participation in any other investigational trial

You have a history of being very sensitive or allergic to any of the ingredients in efgartigimod.

+1 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: efgartigimodExperimental Treatment1 Intervention

patients receiving efgartigimod

Efgartigimod is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Vyvgart for: