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
Sponsor: EMD Serono + Merck KGaA, Darmstadt, Germany
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV)
Time frame: Baseline, LOV (Week 48)
Secondary Endpoints
Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye
Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24
Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36
Eligibility 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
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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