A PHASE 2/3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP, 2-ARM, MULTICENTER, OPERATIONALLY SEAMLESS STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, PHARMACODYNAMICS, PHARMACOKINETICS, AND IMMUNOGENICITY OF EFGARTIGIMOD PH20 SC IN PARTICIPANTS AGED 18 YEARS AND OLDER WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHY

Registry ID

ARGX-113-2007

Source registry

HEALTH_CANADA

Status

Closed

Phase

PHASE2

Study type

INTERVENTIONAL

Sponsor

ARGENX BV

Start date

2023-07-20

Completion date

2025-10-09

Last update

2022-10-12

Conditions

• IDIOPATHIC INFLAMMATORY MYOPATHY

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• A PHASE 3, SINGLE-ARM, MULTICENTER, OPEN-LABEL EXTENSION OF STUDY ARGX-113-2007 TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF EFGARTIGIMOD PH20 SC IN PARTICIPANTS AGED 18 YEARS AND OLDER WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHY

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