Atacicept in Subjects With Optic Neuritis

Status:	Terminated
Conditions:	Ocular
Therapuetic Areas:	Ophthalmology
Healthy:	No
Age Range:	18 - 60
Updated:	4/21/2016
Start Date:	June 2008
End Date:	January 2011

A Two-arm, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Evaluate Safety and Tolerability and to Explore the Neuroprotective Effect of Atacicept as Assessed by Optical Coherence Tomography (OCT) in Subjects With Optic Neuritis (ON) as Clinically Isolated Syndrome (CIS) Over a 36-week Treatment Course

This study was intended to evaluate the efficacy, safety and tolerability of atacicept
compared to placebo and to explore the neuroprotective effect of atacicept as assessed by
OCT in subjects with ON as CIS. The study was randomized. Study medication was administered
via subcutaneous (under the skin) injections.

Inclusion Criteria:

- Diagnosis of unilateral symptomatic optic neuritis as first clinical manifestation
within 28 days between onset of symptoms and study Day 1

- Other protocol defined inclusion criteria could apply

Exclusion Criteria:

- Pre treatment with immunosuppressants and immunomodulating drugs

- Relevant cardiac, hepatic and renal diseases

- Clinical significant abnormalities in blood cell counts and immunoglobulin levels

- Clinical significant acute or chronic infections

- Other protocol defined exclusion criteria could apply

We found this trial at

sites

Clinical Trial Facility in Philadelphia Pennsylvania

Philadelphia, Pennsylvania

from

Philadelphia, PA