A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia

Conditions

• Primary Immune Thrombocytopenia (ITP)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Efgartigimod IV — BIOLOGICAL
  Intravenous infusion of efgartigimod
• Placebo IV — OTHER
  Intravenous infusion of placebo

Study Details

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

Key Dates

Start date

Oct 18, 2024

Status verified

Apr 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

69 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Efgartigimod IV
  Participants receiving efgartigimod IV during the double-blinded treatment period and the open-label treatment period(s)
• Experimental: Placebo IV
  Participants receiving placebo IV during the double-blinded treatment period and receiving efgartigimod IV during the open-label treatment period(s)

Primary Outcome Measure

Extent of disease control, defined as the number of cumulative weeks during the 24-week Double-Blinded Treatment Period with platelet counts of at least 50 × 10^9/L [ Time Frame: Up to 24 weeks ]

Central Contacts

• Sabine Coppieters, MD
  857-350-4834
  [email protected]

Locations (18)

Find similar trials in Phoenix, AZ

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