Atacicept in Subjects With Optic Neuritis

• Status: Terminated
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany

Criteria

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