A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

Summary

This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.

Timeline

Start

2020-12-16

Primary completion

2023-10-09

Completion

2023-10-09

Publications

• Cooper N, Broome CM, Miyakawa Y, McDonald V, Al-Samkari H, Khelif A, Cataland SR, Barcellini W, Yang R, Mei H, Matthijssens F, Hultberg A, Ciurlia G, Gandini D, Ayguasanosa J, De Beuf K, Pastouret S, Ghanima W, Rodeghiero F, Bussel JB; ADVANCE SC Investigator Trial Group. Efficacy and Safety of Subcutaneous Efgartigimod PH20 in Adults With Primary Immune Thrombocytopenia (ADVANCE SC): A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 3 Trial. Am J Hematol. 2026 Jul;101(7):1494-1506. doi: 10.1002/ajh.70303. Epub 2026 Apr 6.

Drugs

Indications