Atacicept in Subjects With Optic Neuritis

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