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A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04660539
Recruitment Status : Active, not recruiting
First Posted : December 9, 2020
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in patrticipants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of studies BN40898 and BN40900. Participants will receive satralizumab as monotherapy or in combination with one of the following background immunosuppressive treatments: azathioprine (AZA), mycophenolate mofetil (MMF), or oral corticosteroids.

Condition or disease Intervention/treatment Phase
Neuromyelitis Optica Spectrum Disorder Drug: satralizumab Drug: azathioprine (AZA) Drug: mycophenolate mofetil (MMF) Drug: oral corticosteroids Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 127 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Actual Study Start Date : March 2, 2021
Estimated Primary Completion Date : May 25, 2024
Estimated Study Completion Date : May 25, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Satralizumab Treatment
Participants will receive satralizumab subcutaneously (SC) every 4 weeks (Q4W)
 Drug: satralizumab
Satralizumab will be administered by SC injection in the abdominal or femoral region at a dose of 120 mg (fixed dose) Q4W for up to 3 years
Other Name: Enspryng

Drug: azathioprine (AZA)
Participants are permitted to use AZA during the study as background immunosuppressive treatment at a maximum dose of 3 milligram per kilogram per day (mg/kg/day)
Other Name: non-investigational medicinal product (NIMP)

Drug: mycophenolate mofetil (MMF)
Participants are permitted to use MMF during the study as background immunosuppressive treatment at a maximum dose of 3000 mg/day
Other Name: NIMP

Drug: oral corticosteroids
Participants are permitted to use oral corticosteroids (prednisolone equivalent) during the study as background immunosuppressive treatment at a maximum dose of 15 mg/day
Other Name: NIMP


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AE) AEs of Special Interest (AESI), Serious AEs (SAE), and Selected AEs [ Time Frame: Up to 39 Months ]
  2. Columbia-Suicide Severity Rating Scale (C-SSRS) Scores [ Time Frame: Up to 39 Months ]

Secondary Outcome Measures :
  1. Percentage of Participants with Serious Infections and Hepatotoxicity [ Time Frame: Up to 39 Months ]
    Participants with NMOSD who are treated with satralizumab

  2. Time to First Relapse (TFR) [ Time Frame: Up to 39 Months ]
  3. Percentage of Relapse-Free Participants [ Time Frame: Up to 39 Months ]
  4. Annualized Relapse Rate (ARR) [ Time Frame: Up to 39 Months ]
  5. Change in Expanded Disability Status Scale (EDSS) Score [ Time Frame: Up to 39 Months ]
  6. Time to EDSS Worsening [ Time Frame: Up to 39 Months ]
  7. Percentage of Participants without EDSS Worsening [ Time Frame: Up to 39 Months ]
  8. Change in Visual Acuity Assessed by a Snellen 20-Foot Wall Chart [ Time Frame: Up to 39 Months ]
    The test will be performed monocularly and participants may use their habitual distance glasses or contact lenses

  9. Concentrations of Interleukin-6 (IL-6) and Soluble IL-6 Receptor (sIL-6R) in Blood [ Time Frame: Up to 39 Months ]
    Measured in picogram per milliliter (pg/mL)

  10. Concentration of C-Reactive Protein (CRP) in Blood [ Time Frame: Up to 39 Months ]
    Measured in milligram per liter (mg/L)

  11. Serum Concentration of Satralizumab at Specified Timepoints [ Time Frame: Up to 39 Months ]
  12. Percentage of Participants with Anti-Drug Antibodies (ADAs) from the First Dose of Satralizumab in Studies BN40898 or BN40900 (parent studies) [ Time Frame: Up to 39 Months ]
  13. Percentage of Participants with ADA to Satralizumab [ Time Frame: Up to 39 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants aged less than 18 years at the time of informed consent for Study BN40898 can continue treatment with a combination of oral corticosteroids and either AZA or MMF
  • Participated in Study BN40898 or Study BN40900 with satralizumab in NMOSD, are on ongoing satralizumab treatment and were anti-aquaporin-4 IgG antibody (AQP4-IgG) seropositive at screening in these studies. Participants with NMOSD who were AQP4-IgG seronegative at screening in Study BN40898 or Study BN40900 can be enrolled if the investigator considers the continued treatment with satralizumab to be beneficial for the participant
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 3 months after the final dose of satralizumab.

Exclusion Criteria:

  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug. Women of childbearing potential must have a negative urine pregnancy test result on the baseline visit prior to initiation of study drug
  • Evidence of any serious uncontrolled concomitant diseases that may preclude participation including 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
  • Known active infection that requires delaying the next satralizumab dose at the time of enrollment
  • NMOSD relapse at the time of enrollment
  • Laboratory abnormalities at the last assessment in Study BN40898 or Study BN40900 that preclude re-treatment with satralizumab
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04660539


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04660539    
Other Study ID Numbers: WN42349
2020-003413-35 ( EudraCT Number )
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuromyelitis Optica
Myelitis, Transverse
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Azathioprine
 Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents