A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia

argenx121 sites in 10 countries131 target enrollmentDecember 16, 2019

ConditionsPrimary Immune Thrombocytopenia

Interventionsefgartigimod Placebo

Drugsefgartigimod

Overview

Phase: Phase 3
Intervention: efgartigimod
Conditions: Primary Immune Thrombocytopenia
Sponsor: argenx
Enrollment: 131
Locations: 121
Primary Endpoint: Percentage of Participants With Chronic ITP With a Sustained Platelet Count Response Defined as Achieving Platelet Counts of at Least 50×10^9/L for at Least 4 of the 6 Visits Between Week 19 and 24 of the Trial.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in participants with primary ITP.

Registry

clinicaltrials.gov

Start Date

December 16, 2019

End Date

February 3, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

argenx

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

efgartigimod

Patient receiving efgartigimod

Intervention: efgartigimod

Placebo

Patients receiving placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage of Participants With Chronic ITP With a Sustained Platelet Count Response Defined as Achieving Platelet Counts of at Least 50×10^9/L for at Least 4 of the 6 Visits Between Week 19 and 24 of the Trial.

Time Frame: From Week 19 up to Week 24

Percentage of participants with chronic ITP with a sustained platelet count response was defined as achieving platelet counts of at least 50 × 10\^9/L for at least 4 of the 6 visits between Week 19 and 24 of the study.

Secondary Outcomes

Extent of Disease Control Defined as the Number of Cumulative Weeks Over the Planned 24-week Treatment Period With Platelet Counts of ≥50×10^9/L in the Chronic ITP Population(From Week 1 up to Week 24)
Percentage of Participants With a Sustained Platelet Count Response for at Least 4 of the 6 Visits Between Week 19 and 24 of the Study(From Week 19 up to Week 24)
Incidence and Severity of the WHO-classified Bleeding Events(From Week 1 to Week 24)
Percentage of Participants in the Overall Population Achieving Platelet Counts of at Least 50×10^9/L for at Least 6 of the 8 Visits Between Week 17 and Week 24(From Week 17 up to Week 24)