BridgeMD
A study to assess the Efficacy and Safety of Efgartigimod IV in Adult Participants with Primary Immune Thrombocytopenia
EU CTIS ID: 2024-515451-38-00
What this study is testing
To evaluate the efficacy of efgartigimod IV compared with placebo IV in the extent of disease control
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Is at least 18 years of age and the local legal age of consent for clinical studies when signing the informed consent form (ICF).
- Has documented baseline mean platelet count of <30 x 10^9/L before randomization
- 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 (for participants who are nonsplenectomized and Rho(D)- positive), thrombopoietin receptor agonist (TPO-RAs), or rituximab
- Has documented insufficient response to a prior ITP treatment with corticosteroids, IVIg, anti-D immunoglobulin (for participants who are nonsplenectomized and Rho(D)-positive), TPO-RAs, rituximab (the specific criteria can be found in the protocol).
- Has documented prior response defined as 1 platelet count of ≥50 × 10^9/L to at least 1 of the following ITP treatments in the 3 years before the date of ICF signature: prednisone, dexamethasone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin (for participants who are nonsplenectomized and Rho(D)-positive).
You likely can't join if
- Other than the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of ITP, confound the results of the study or put the participant at undue risk.
- Secondary ITP
- Nonimmune thrombocytopenia
- Autoimmune hemolytic anemia
- ITP-associated critical or severe bleeding
The study team makes the final eligibility decision.
Where it's taking place
- United States
- China
- Serbia
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; China; Serbia; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.