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Monoclonal Antibodies
Satralizumab for NMOSD (SAkuraBonsai Trial)
Phase 4
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day -28 to day -1) to week 96
Awards & highlights
SAkuraBonsai Trial Summary
This trial is testing a new drug for people with a certain kind of autoimmune disease. The disease affects the nervous system and causes problems with vision, movement, and other neurological functions. The new drug is designed to help people who haven't responded well to other treatments.
Eligible Conditions
- Neuromyelitis Optica Spectrum Disorders
- Neuromyelitis Optica Spectrum Disorder
SAkuraBonsai Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day -28 to day -1) to week 96
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day -28 to day -1) to week 96
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Annualized relapse rate (ARR)
Change from baseline in the Symbol Digital Modalities Test (SDMT) over the course of the study
Change in high-contrast (100%) and lowcontrast (2.5%) visual acuity using appropriate high-and low-contrast letter acuity (LCLA) charts over the course of the study
+9 moreSecondary outcome measures
Change in the ganglion cell plus inner plexiform (GCIP) layer thickness
Change in the retinal nerve fiber layer (RNFL) thickness
Count, volume and regional distribution of T2-weighted fluid-attenuated inversion-recovery (FLAIR) hyperintense lesions
+5 moreSAkuraBonsai Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: NMOSD patients who are inadequate responders to previous treatment with RTXExperimental Treatment1 Intervention
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).
Group II: Cohort 1: treatment-naïve NMOSD patientsExperimental Treatment1 Intervention
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).
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,882 Total Patients Enrolled
2 Trials studying Neuromyelitis Optica Spectrum Disorders
127 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders
Chugai Pharmaceutical Co.UNKNOWN
3 Previous Clinical Trials
397 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,599 Total Patients Enrolled
2 Trials studying Neuromyelitis Optica Spectrum Disorders
127 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you are a woman who can have children, you agree to either not have sex or use reliable birth control methods (like condoms, birth control pills, or intrauterine devices) during the treatment and for at least 3 months after stopping the study drug.You are not able to finish an MRI scan.You have not previously been treated with long-term disease-modifying or immunosuppressive therapy.You have been treated with certain medications like eculizumab, belimumab, natalizumab, or others in the past.You have been treated with certain medications called anti-CD4, cladribine, or mitoxantrone before.You have received treatment with medications that reduce B-cells in the past.You have been diagnosed with a specific type of rare nervous system disorder called AQP4 antibody seropositive NMOSD.You have another type of nerve disease like multiple sclerosis or progressive multifocal leukoencephalopathy (PML).You have signs of active tuberculosis (TB).You have had problems with drugs or alcohol in the last year.You have a history of diverticulitis that could cause more serious problems.You stopped taking RTX (or a similar medication) for a reason other than it not working for you.You have been treated with RTX or its similar drug for a specific condition within the last 6 months before joining the study.You are still experiencing symptoms of your condition after your last RTX treatment, such as a relapse or new inflammation, which has been confirmed by MRI or an eye exam.You have been diagnosed with NMOSD and tested positive for AQP4 antibodies.You have had at least one documented attack or relapse in the year before screening.You have not previously been treated with ongoing medication to control your disease.You have been diagnosed with neuromyelitis optica spectrum disorder (NMOSD) and have AQP4+ antibodies in your medical history.You have had symptoms of the disease for less than 5 years.You have been diagnosed with AQP4 antibody seropositive NMOSD according to specific criteria.You have taken medications that weaken the immune system before.You currently have a bacterial, viral, fungal, or other type of infection that keeps coming back.You have signs of ongoing hepatitis B infection.You have a history of blood clotting problems or abnormal blood test results related to clotting.You received a live vaccine within 6 weeks before the study starts.You have had cancer in the past or currently have cancer.You have had a serious allergic reaction to a biologic medicine in the past.You have recently had thoughts of hurting yourself or have tried to hurt yourself in the past few years.You need to be between 18 and 74 years old when you agree to take part in the study.You have been treated with certain types of therapy in the past, such as IL-6 inhibitory therapy, alemtuzumab, total body irradiation, stem-cell therapy, or bone marrow transplantation.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: treatment-naïve NMOSD patients
- Group 2: Cohort 2: NMOSD patients who are inadequate responders to previous treatment with RTX
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor include participants of sixty years or older?
"This medical trial invites individuals aged between 18 to 74 years old. For minors and seniors, there are a respective 6 trials and 16 studies for them respectively."
Answered by AI
Who is eligible to partake in this medical research?
"The requisite qualifications for this research study demand that participants have neuromyelitis optica, and be between 18-74 years of age. Around one hundred individuals are sought to partake in the trial."
Answered by AI
What is the aggregate figure of individuals participating in this research project?
"Hoffmann-La Roche, the sponsor of this trial, is aiming to recruit 100 suitable patients from two locations: Stanford Health Care in California and University Of Colorado in Aurora."
Answered by AI
How effective is a Satralizumab 120 mg dosage in terms of patient safety?
"There is ample evidence demonstrating the safety of Satralizumab 120 mg, leading to its score of 3 in our assessment. This treatment has been approved and reached Phase 4 trials."
Answered by AI
Are researchers still accepting participants for this research trial?
"As per the information posted on clinicaltrials.gov, this research endeavour is currently recruiting participants. It was first put up for public knowledge on August 2nd 2022 and recently revised on November 21st 2022."
Answered by AI
Are there numerous establishments administering this experiment within the state?
"This clinical study is recruiting participants at Stanford Health Care (Stanford, CA), University Of Colorado (Aurora, CO) and Massachusetts General Hospital (Boston, MA). There are 4 other sites as well."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What state do they live in?
New York
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