An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients

Alexion Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder

Treatments: Biological: eculizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02003144

2013-001151-12 (EudraCT Number)

ECU-NMO-302

Details and patient eligibility

About

The purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing NMO.

Full description

This study is an open label extension study to confirm the long term safety and efficacy of eculizumab in subjects with relapsing NMO who have completed the initial double-blind, randomized, placebo-controlled trial ECU-NMO-301.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Patient completed the ECU-NMO-301 trial
2. Patient has given written informed consent

Key Exclusion Criteria:

1. Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to trial drug
2. Female patients who are pregnant, breastfeeding, or intend to conceive during the course of the trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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119 participants in 1 patient group

Eculizumab

Experimental group

Description:

Eculizumab intravenous infusion every two weeks.

Treatment:

Biological: eculizumab