Trial intelligence / Profile preview

Phase 1 comparison of subcutaneous versus intravenous efgartigimod in healthy volunteers

NL-OMON49985Phase 1Completed

Sponsor
argenx
Start
Aug 2020
Modality
Therapeutic Enzymes → Recombinant Proteins and Enzymes, Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics
Countries
1
01

Overview

Phase 1, randomised, open-label trial in autoimmune disease, myasthenia gravis (MG), pemphigus and 1 more comparing Intravenous efgartigimod with Subcutaneous efgartigimod PH20 SC (2 arms). Primary endpoint: Noninferiority of pharmacodynamic effect on total IgG at Day 29. Started Aug 2020; status: completed.

02

Drugs

efgartigimod alfaENHANZE
03

Conditions

autoimmune diseasemyasthenia gravis (MG)pemphigusimmune thrombocytopenia (ITP)

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