Trial intelligence / Profile preview

ADVANCE SC: Efgartigimod PH20 SC in Primary ITP

NCT04687072Phase 3

Key facts

Status: Completed
Start: Dec 2020
Primary completion: Oct 2023
Countries: 32
Sponsor: argenx
Modality: Antibody Fragments

Drugs: efgartigimod alfa
Conditions: primary immune thrombocytopenia (ITP)

Overview

Phase 3, randomised, double-blind trial in primary immune thrombocytopenia (ITP) comparing Efgartigimod PH20 SC with Placebo PH20 SC (2 arms). Primary endpoint: Percentage of Participants With Chronic Immune Thrombocytopenia With a Sustained Platelet Count Response Between Weeks 19 and 24 at Week 24. Started Dec 2020; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Efgartigimod PH20 SC
Efgartigimod PH20 SC + Standard of Care (optional)
Placebo PH20 SC
Placebo PH20 SC + Standard of Care (optional)

Who it enrols

Adult patients with confirmed primary ITP diagnosed >3 months ago, with a mean platelet count <30x10^9/L, who have received at least one prior ITP therapy (or two if not currently on treatment).

Endpoints

Primary

Percentage of Participants With Chronic Immune Thrombocytopenia With a Sustained Platelet Count Response Between Weeks 19 and 24Week 24

Secondary

Extent of Disease Control Over the 24-Week Treatment Period in the Chronic ITP Population24 weeks
Percentage of Participants in the Overall Population Achieving Overall Platelet Count Response at Any Time During the 24-week Treatment Period24 weeks
Number of the World Health Organization (WHO)-Classified Bleeding Events (Grade >=1) in the Overall Population24 weeks
Rate of Receipt of Rescue Therapy (Rescue Per Participant Per Month) in the Overall Population24 weeks
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue) at Week 24Week 24
Incidence and Prevalence of Antibodies to Efgartigimod and/or rHuPH2035 weeks
Percentage Change From Baseline in Total IgG in the Overall PopulationWeek 24

Results

Not all primary endpoints met

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