A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)

Phase 1/2 Terminated 8 enrolled Alexion Pharmaceuticals, Inc.

Non-randomizedSequentialOpen-labelTreatment

Summary

This was a multicenter, open-label safety study to determine the dose regimen of SYNT001 (ALXN1830) administered intravenously in participants with pemphigus (vulgaris or foliaceus).

Timeline

Start: 2017-07-18
Primary completion: 2019-01-16
Completion: 2019-01-16

Outcome

Outcome not reported

Stopped: “Study objectives achieved”

Publications

Werth VP, Culton DA, Concha JSS, Graydon JS, Blumberg LJ, Okawa J, Pyzik M, Blumberg RS, Hall RP 3rd. Safety, Tolerability, and Activity of ALXN1830 Targeting the Neonatal Fc Receptor in Chronic Pemphigus. J Invest Dermatol. 2021 Dec;141(12):2858-2865.e4. doi: 10.1016/j.jid.2021.04.031. Epub 2021 Jun 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ORILANOLIMAB	Monoclonal antibody	10 mg/kg	Intravenous