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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
Stopped earlyPhase 2Early (CIS/RIS)NCT00624468

What it found

Stopped early

The trial ended early for another reason (see below).

Reason given: EMD Serono voluntarily decided to terminate this trial after observing increased MS disease activity in trial 28063 ATAMS \[Please refer to ATAMS\]

What was tested

Treatment tested

  • Atacicept

    Tumor necrosis factor ligand superfamily member 13 inhibitor|Tumor necrosis factor ligand superfamily member 13B inhibitor

Placebo or sham

  • Placebo matched to atacicept

Results by group

Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV)

Baseline, LOV (Week 48)

GroupValueIntervalNumber analysed
Placebo: Double-blind Period103.893 micrometer17.271 (Standard Deviation)17
Atacicept: Double-blind Period104.170 micrometer8.832 (Standard Deviation)17
Placebo: Double-blind Period-17.317 micrometer15.158 (Standard Deviation)17
Atacicept: Double-blind Period-8.636 micrometer10.056 (Standard Deviation)17

Placebo: Double-blind Period

103.893

Atacicept: Double-blind Period

104.17

Placebo: Double-blind Period

-17.317

Atacicept: Double-blind Period

-8.636

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Placebo: Double-blind Period170 (0.0%)
Atacicept: Double-blind Period170 (0.0%)
Placebo: SFU Period131 (7.7%)
Atacicept: SFU Period142 (14.3%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV)

    Baseline, LOV (Week 48)

    Retina scans (OCT)

Other measures (9)

  • Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye

    Weeks 12, 24 and 36

    Retina scans (OCT)

  • Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24

    Baseline, Weeks 12 and 24

    Retina scans (OCT)

  • Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36

    Baseline, Weeks 12, 24 and 36

  • Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36

    Baseline, Weeks 12, 24 and 36

  • Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36

    Baseline, Weeks 12, 24 and 36

  • Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified

    Weeks 12, 24 and 36

    Vision

  • Contrast Sensitivity: Total Number of Letters Correctly Identified

    Weeks 12, 24 and 36

  • Contrast Sensitivity: Score Line

    Weeks 12, 24 and 36

  • Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack

    From baseline (Study Day 1) up to Week 36

    Disability progressionRelapses

Who could take part

Early (CIS/RIS) · 18 to 60

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Jun 2008

      2. Main results due

        Sept 2009

      3. Finished

        Jan 2011

      4. Results posted

        Feb 2016

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