drugset / Trial / NCT01530256

Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD)

NCT01530256 ↗

Phase 1/2 Terminated 3 enrolled CSL Behring
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the safe and tolerable, biologically active, and potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to respond to glucocorticosteroids, for further investigation in Part B.

Timeline

Start
2012-03
Primary completion
2013-03
Completion
2013-03

Outcome

Outcome not reported

Stopped: “The trial was terminated in line with the endpoint committee charter.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Clazakizumab Monoclonal antibody 160 mg Intravenous
Subject Clazakizumab Monoclonal antibody 320 mg Intravenous
Subject Clazakizumab Monoclonal antibody 640 mg Intravenous