NCT06544499 A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
| NCT ID | NCT06544499 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | argenx |
| Condition | Primary Immune Thrombocytopenia (ITP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 69 participants |
| Start Date | 2024-10-18 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 69 participants in total. It began in 2024-10-18 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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). At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first 52-week open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second 52-week OLTP2. After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks. More information can be found here: https://clinicaltrials.argenx.com/advancenext
Eligibility Criteria
Inclusion 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 corticosteroids, IVIg, or anti-D immunoglobulin Exclusion Criteria: * 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 complete list of criteria can be found in the protocol.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06544499 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Immune Thrombocytopenia (ITP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06544499 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 69 participants.
Is NCT06544499 currently recruiting?
Yes, NCT06544499 is actively recruiting participants. Contact the research team at Clinicaltrials@argenx.com for enrollment information.
Where is the NCT06544499 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, Oceanside, United States, Aurora, United States and 11 additional locations.
Who is sponsoring the NCT06544499 clinical trial?
NCT06544499 is sponsored by argenx. The trial plans to enroll 69 participants.