ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon

A 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Fingolimod in the Treatment of Relapsing-remitting Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01621269

Acronym

ENGYNE

Enrollment

Registered

2012-06-18

Start date

2013-06-30

Completion date

2014-06-30

Last updated

2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, MS, Fingolimod, Gilenya, Neutralizing Antibodies, NAb

Brief summary

Study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12 months

Interventions

DRUGFingolimod

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Male or female subjects aged 18-65 years * Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria * Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5 * Interferon-beta (IFN-β) treatment for at least 18 months. * Positive IFN-NAb titer at screening or within 6 months prior to screening * Patients with disease activity despite treatment with IFN-ß measured by gadolinium-enhancing lesions on T1-weighted images on MRI using a triple-dose gadolinium protocol and/or new or newly enlarging T2 lesions (T2 lesions: compared to a reference MRI performed within the last 18 months)

Exclusion criteria

* patients with previous or current disease of immune system * active infections * cardiovascular risk patients * Patients unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with active MRI lesions	12 months	number of patients with neutralizing antibodies against IFN-ß with reduction of number of combined unique active lesions on brain MRI (CUAL) defined as those lesions that are new or recurrent or enlarging on T2-weighted scans or those that are new and taking Gd-enhancement on T1-weighted scans, avoiding double counting

Secondary

Measure	Time frame	Description
Number of patients with adverse events	12 months	safety of fingolimod as measured by number of adverse events

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026