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Tests treatment safety and results for Primary Immune Thrombocytopenia (ITP)
Official title A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
ClinicalTrials.gov ID: NCT06544499
What this study is testing
What is Efgartigimod IV?
Efgartigimod IV is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary immune thrombocytopenia (itp).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this study is to look at the effect (efficacy) and safety of efgartigimod IV in participants with primary immune thrombocytopenia (ITP). After an up to 2 weeks screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV, respectively during the double-blinded treatment period (DBTP).
- Phase 3: a large, late-stage study
- Time commitment: about 138 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- Has documented insufficient response to a prior ITP treatment (the specific criteria can be found in the protocol).
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...
- Secondary ITP
- Nonimmune thrombocytopenia
- Autoimmune hemolytic anemia
- ITP-associated critical or severe bleeding The complete list of criteria can be found in the protocol.
See the full eligibility criteria
- 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, thrombopoietin receptor agonist (TPO-RAs), or rituximab.
- Has documented insufficient response to a prior ITP treatment (the specific criteria can be found in the protocol).
- Has documented prior response defined as 1 platelet count of ≥50 × 109/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...
- 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...
- Secondary ITP
- Nonimmune thrombocytopenia
- Autoimmune hemolytic anemia
- ITP-associated critical or severe bleeding The complete list of criteria can be found in the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Oceanside, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- New Orleans, Louisiana, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Little Silver, New Jersey, United States
- Westbury, New York, United States
- Durham, North Carolina, United States
- Greenville, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Linz, Austria
- Wels, Austria
+ 61 more site(s).
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 study runs about 138 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; Oceanside, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Washington D.C., District of Columbia, United States and 75 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.