Trial intelligence / Profile preview

Satralizumab in NMO and NMOSD (SAkuraSky)

NCT02028884Phase 3

Key facts

Status: Completed
Start: Feb 2014
Primary completion: Jun 2018
Countries: 11
Sponsor: Roche
Modality: Monoclonal Antibodies

Drugs: satralizumab
Conditions: Neuromyelitis Optica Spectrum Disorder (NMOSD)

Overview

Phase 3, randomised, double-blind trial in Neuromyelitis Optica Spectrum Disorder (NMOSD) comparing Satralizumab + Baseline Treatment with Placebo + Baseline Treatment (2 arms). Primary endpoint: Time to First Protocol-Defined Relapse. Started Feb 2014; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Satralizumab + Baseline Treatment
Satralizumab SC + Baseline IST
Placebo + Baseline Treatment
Placebo SC + Baseline IST

Who it enrols

Patients aged 12-74 with NMO or NMOSD, at least 2 relapses in the last 2 years, EDSS 0-6.5, and on stable baseline treatment with azathioprine, mycophenolate mofetil, or oral corticosteroids.

Endpoints

Primary

Time to First Protocol-Defined RelapseUp to Week 224

Secondary

Visual Analogue Scale for PainWeek 24
Functional Assessment of Chronic Illness Therapy Fatigue ScoreWeek 24
Relapse-Free RateUp to Week 216
Annualized Relapse RateUp to Week 216
Modified Rankin ScaleUp to Week 216
Expanded Disability Status ScaleUp to Week 216
Visual Acuity (Snellen Chart)Up to Week 216
Short Form Generic Health SurveyUp to Week 216

Results

Primary endpoints met

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