SAkuraBonsai: Clinical, Imaging And Biomarker Open-Label Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention

Who is this study for? Patients with neuromyelitis optica spectrum disorder
What treatments are being studied? Satralizumab
Status: Terminated
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Objective of the trial is to describe the efficacy and safety of satralizumab in patients with aquaporin-4 (AQP4) antibody seropositive NMOSD, either treatment naive or inadequate responders to previous treatment with rituximab (RTX) (or its biosimilar)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:

• Age 18 to 74 years, inclusive, at the time of informed consent

• Have a diagnosis of AQP4 antibody seropositive NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria

• For women of childbearing potential: agreement to either remain abstinent (refrain from heterosexual intercourse) or 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 Cohort 1 (treatment-naïve NMOSD patients)

• Confirmation of NMOSD diagnosis with AQP4+ antibodies

• Have clinical evidence of at least 1 documented attack or relapse (including first attack) in the last year prior to screening

• Naive to maintenance therapy (disease-modifying therapy \[DMT\] or immunosuppressive therapy \[IST\]) Cohort 2 (NMOSD patients with inadequate response to RTX \[or its biosimilar\])

• Confirmation of NMOSD diagnosis and AQP4+ antibodies in the disease history of the patient

• Have a length of disease duration from first symptom of ≤5 years

• History of ongoing treatment with RTX (or its biosimilar) (at least 2 infusions) for NMOSD with a maximum duration of 6 months since last administration prior to enrolment in the study

• Ongoing disease activity after last RTX (or its biosimilar) infusion i.e., relapse and/or any new inflammatory event, confirmed by magnetic resonance imaging (MRI) or ophthalmological assessment

Locations
United States
Kansas
University of Kansas Medical Center
Kansas City
Other Locations
Republic of Korea
National Cancer Center
Goyang-si
Turkey
Ondokuz Mayis University School of Medicine
Samsun
Time Frame
Start Date: 2022-08-02
Completion Date: 2023-10-26
Participants
Target number of participants: 4
Treatments
Experimental: Cohort 1: treatment-naïve NMOSD patients
Patients will be treated with 120 mg satralizumab subcutaneously (SC) as monotherapy at Weeks 0, 2 (±3 days), 4 (±3 days), and then every 4 weeks (±3 days) till the last administration at Week 92 followed by a clinical evaluation at Week 96. The first dose at Week 0 (baseline visit) will be administered at the study site by the designated site staff during the scheduled study visit. All assessments (clinical, laboratory and imaging) should be performed before satralizumab administration. The next dose at Week 2 will be self-administered by the patient under the supervision of a designated study staff at the study site. All the subsequent doses will be self-administered by the patient following training from a healthcare provider (for patients who are not able to administer satralizumab SC by themselves, support by a caregiver/nurse is advised).
Experimental: Cohort 2: NMOSD patients who are inadequate responders to previous treatment with RTX
Patients will be treated with 120 mg satralizumab subcutaneously (SC) as monotherapy at Weeks 0, 2 (±3 days), 4 (±3 days), and then every 4 weeks (±3 days) till the last administration at Week 92 followed by a clinical evaluation at Week 96. The first dose at Week 0 (baseline visit) will be administered at the study site by the designated site staff during the scheduled study visit. All assessments (clinical, laboratory and imaging) should be performed before satralizumab administration. The next dose at Week 2 will be self-administered by the patient under the supervision of a designated study staff at the study site. All the subsequent doses will be self-administered by the patient following training from a healthcare provider (for patients who are not able to administer satralizumab SC by themselves, support by a caregiver/nurse is advised).
Sponsors
Collaborators: Chugai Pharmaceutical Co.
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov