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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04660539
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE November 24, 2020
First Posted Date  ICMJE December 9, 2020
Last Update Posted Date January 11, 2022
Actual Study Start Date  ICMJE March 2, 2021
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
  • Percentage of Participants with Adverse Events (AE) AEs of Special Interest (AESI), Serious AEs (SAE), and Selected AEs [ Time Frame: Up to 39 Months ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) Scores [ Time Frame: Up to 39 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
  • Percentage of Participants with Serious Infections and Hepatotoxicity [ Time Frame: Up to 39 Months ]
    Participants with NMOSD who are treated with satralizumab
  • Time to First Relapse (TFR) [ Time Frame: Up to 39 Months ]
  • Percentage of Relapse-Free Participants [ Time Frame: Up to 39 Months ]
  • Annualized Relapse Rate (ARR) [ Time Frame: Up to 39 Months ]
  • Change in Expanded Disability Status Scale (EDSS) Score [ Time Frame: Up to 39 Months ]
  • Time to EDSS Worsening [ Time Frame: Up to 39 Months ]
  • Percentage of Participants without EDSS Worsening [ Time Frame: Up to 39 Months ]
  • 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
  • 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)
  • Concentration of C-Reactive Protein (CRP) in Blood [ Time Frame: Up to 39 Months ]
    Measured in milligram per liter (mg/L)
  • Serum Concentration of Satralizumab at Specified Timepoints [ Time Frame: Up to 39 Months ]
  • 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 ]
  • Percentage of Participants with ADA to Satralizumab [ Time Frame: Up to 39 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuromyelitis Optica Spectrum Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Satralizumab Treatment
Participants will receive satralizumab subcutaneously (SC) every 4 weeks (Q4W)
Interventions:
  • Drug: satralizumab
  • Drug: azathioprine (AZA)
  • Drug: mycophenolate mofetil (MMF)
  • Drug: oral corticosteroids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2020)
127
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2024
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: WN42349 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Bulgaria,   Canada,   Croatia,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Poland,   Puerto Rico,   Romania,   Spain,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries Turkey
 
Administrative Information
NCT Number  ICMJE NCT04660539
Other Study ID Numbers  ICMJE WN42349
2020-003413-35 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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).
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP