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Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

NCT02028884•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic, and immunogenic profiles of satralizumab, compared with placebo, in addition to baseline immunosuppressive treatment in participants with NMO and NMOSD.

Eligibility

Age

12 - 74 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients must be diagnosed as having either neuromyelitis optica (NMO) or NMO spectrum disorder (NMOSD), defined as the following:
•1. NMO as defined by Wingerchuk et al. 2006 criteria (requires all of the following 3 criteria: I. Optic neuritis, II. Acute myelitis, III. At least two of three supportive criteria: Contiguous spinal cord lesion identified on a magnetic resonance imaging (MRI) scan extending over 3 vertebral segments; Brain MRI not meeting diagnostic criteria for multiple sclerosis (MS); NMO-IgG seropositive status)
•2. NMOSD as defined by either of the following Wingerchuk 2007 criteria with anti-AQP4 antibody (Ab) seropositive status at screening (i. Idiopathic single or recurrent events of longitudinally extensive myelitis \[≥3 vertebral segment spinal cord MRI lesion\]; ii. Optic neuritis: recurrent or simultaneous bilateral); For patients aged 12 to 17 years, a minimum of 4 patients should be positive for anti-AQP4Ab status at screening
•2. Clinical evidence of at least 2 documented relapses (including first attack) in the last 2 years prior to screening, at least one of which has occurred in the 12 months prior to screening
•3. EDSS score from 0 to 6.5 inclusive at screening
•4. Age 12 to 74 years, inclusive at the time of informed consent
•5. One of the following baseline treatments must be at stable dose as a monotherapy for 8 weeks prior to baseline: Azathioprine; Mycophenolate mofetil; Oral corticosteroids. For participants aged 12 to 17 years, either of the following baseline treatments for relapse prevention can be allowed: Azathioprine + oral corticosteroids; Mycophenolate mofetil + oral corticosteroids
•6. Ability and willingness to provide written informed consent and to comply with the requirements of the protocol
•For adolescents who may be enrolled after the end of the double-blind period, the inclusion criterion 2 is as follows (other criteria are same): Clinical evidence of at least 2 documented relapses (including first attack) prior to screening.

Exclusion Criteria

•1. Any previous treatment with IL-6 inhibitory therapy (e.g. tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation at any time
•2. Any previous treatment with anti-CD20, eculizumab, belimumab, interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate within 6 months prior to baseline
•3. Any previous treatment with anti-CD4, cladribine or mitoxantrone within 2 years prior to baseline
•4. Treatment with any investigational agent within 3 months prior to baseline
•Exclusions for general safety:
•5. Pregnancy or lactation
•6. For patients of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception (physical barrier \[patient or partner\] in conjunction with a spermicidal product, contraceptive pill, patch, injectables, intrauterine device or intrauterine system) during the treatment period and for at least 3 months after the last dose of study drug
•7. Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline
•8. Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML)
•9. Evidence of serious uncontrolled concomitant diseases that may preclude patient participation, such as: other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency
+17 more criteria

Locations (40)

Children's Hospital of Alabama

Birmingham, Alabama, United States

Hopital de Hautepierre CHRU de Strasbourg

Strasbourg, France

NeuroCure Clinical Research Center (NCRC)

Berlin, Germany

St. Josef-Hospital, Klinik für Neurologie

Bochum, Germany

Heinrich-Heine Universitätsklinik Düsseldorf

Düsseldorf, Germany

Jahn Ferenc Dél-Pesti Kórház

Budapest, Hungary

Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien

Rome, Lazio, Italy

Ospedale San Raffaele

Milan, Lombardy, Italy

PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

Catania, Sicily, Italy

Fond. Ist. S. Raffaele - giglio

Cefalù, Sicily, Italy

Key Dates

Start Date

February 20, 2014

Primary Completion Date

June 6, 2018

Completion Date

December 23, 2021

Last Updated

April 18, 2023

Enrollment

ACTUAL participants

Conditions

Neuromyelitis Optica (NMO)NMO Spectrum Disorder (NMOSD)

Interventions

Satralizumab

DRUG

Placebo

DRUG

Baseline Treatment

DRUG