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

Primary Purpose

Neuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Satralizumab

Placebo

About this trial

This is an interventional treatment trial for Neuromyelitis Optica (NMO)

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants 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 following criteria with anti-aquaporin-4 (AQP4) antibody seropositive status at screening: i. Idiopathic single or recurrent events of longitudinally extensive myelitis (≥3 vertebral segment spinal cord MRI lesion); ii. Optic neuritis, single, recurrent or simultaneous bilateral
Clinical evidence of at least 1 documented relapse (including first attack) in last 12 months prior to screening
Expanded Disability Status Scale (EDSS) score from 0 to 6.5 inclusive at screening
Age 18 to 74 years, inclusive at the time of informed consent
Ability and willingness to provide written informed consent and to comply with the requirements of the protocol

Exclusion Criteria:

Clinical relapse onset (including first attack) within 30 days prior to baseline
Exclusion Criteria Related to Previous or Concomitant Therapy:
Any previous treatment with interleukin 6 (IL-6) inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation at any time
Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline
Any previous treatment with anti-CD4, cladribine, cyclophosphamide or mitoxantrone within 2 years prior to baseline
Treatment with any investigational agent within 3 months prior to baseline
Exclusions for General Safety:
Pregnancy or lactation.
For participants of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception (physical barrier [participants 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
Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline
Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML)
Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; 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
Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline
Evidence of chronic active hepatitis B or C
History of drug or alcohol abuse within 1 year prior to baseline
History of diverticulitis that, in the Investigator's opinion, may lead to increased risk of complications such as lower gastrointestinal perforation
Evidence of active tuberculosis (excluding participants receiving chemoprophylaxis for latent tuberculosis infection)
Evidence of active interstitial lung disease
Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline
History of malignancy within the last 5 years, including solid tumors, hematologic malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured)
History of severe allergic reaction to a biologic agent (e.g., shock, anaphylactic reactions)
Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening
History of Stevens-Johnson syndrome
Following laboratory abnormalities at screening*.
1. White blood cells <3.0 x10^3/microliter (μL)
2. Absolute neutrophil count <2.0 x 10^3 /μL
3. Absolute lymphocyte count <0.5 x 10^3 /μL
4. Platelet count <10 x 10^4 /μL
5. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal.
  - If retest is conducted, the last value of retest before randomization must meet study criteria.

Sites / Locations

University of Colorado Denver -; Neurology
University of Miami UHealth Professional Arts Center
The MS Center of Vero Beach
Columbus Research and Wellness
University of Chicago; Neurology
Consultants in Neurology Ltd
OSF Saint Francis Medical Center
University of Kansas Medical Center
MidAmerica Neuroscience Institute
University of Michigan Health System
Wayne State University - Comp Clinic and MS. Center
University of North Carolina at Chapel Hill
The Neurological Institute PA
OhioHealth Research Institute
Thomas Jefferson University
University of Texas Southwestern Medical Center
Central Texas Neurology Consultants
UT Medicine San Antonio
Virginia Commonwealth University
Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders
Medical Help Center EOOD
MMA-MHAT Pleven - Clinic for Neurology
UMHAT 'Dr. Georgi Stranski', EAD
MHATNP Sveti Naum EAD
UMHAT Alexandrovska, EAD
MS Clinical Trials Group
Recherche Sepmus Inc.
Centre hospitalier de l'Universite de Montreal (CHUM)
Klinicki bolnicki centar Osijek
LTD Helsicore
Pineo Medical Ecosystem LTD
S.Khechinashvili Tbilisi State Medical University Clinic Ne
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Korea University Anam Hospital - Neurology
Seoul National University Hospital
Asan Medical Center
Severance Hospital - Yonsei University Health System - Neurology
Hospital Universiti Sains Malaysia [Neurology]
Hospital Kuala Lumpur
Philippine General Hospital
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
Miedzyleski Szpital Specjalistyczny w Warszawie
San Juan MS Center
SC Clubul Sanatatii SRL
China Medical University Healthcare System
National Cheng Kung University Hospital; Neurology
Taipei Veterans General Hospital-Neurology
Bilim University Medical Faculty Florence Nightingale Hospital
Ondokuz Mayis Univ. Med. Fac.
Ivano-Frankivska oblasna klinichna likarnia
Ivano-Frankivska miska klinichna likarnia №1
Kiev National Medical University
Municipal Foundation of Kyiv Regional Council " Kyiv Region
Reginal clinical psyconeurological hospital
Vinnytskyi natsionalnyi medychnyi universytet imeni M.I. Pyr
Municipal Establishment "City Clinical Hospital #2; Neurology
Miska Klinichna Likarnia №16
KU "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Satralizumab

Placebo

Arm Description

Participants randomized to this arm for the double-blind period will receive satralizumab monotherapy. The double-blind period for the participant ends either when the participant experiences a Clinical Endpoint Committee (CEC) confirmed protocol-defined relapse, the total number of CEC confirmed protocol-defined relapses reaches 44, or 1.5 years after the last patient was randomized. In the open-label extension period, the participant will receive satralizumab SC injection at Weeks 0, 2, and 4, and Q4W thereafter, up to the end of the study.

Participants randomized to this arm for the double-blind period will receive placebo monotherapy. The double-blind period for the participant ends either when the participant experiences a Clinical Endpoint Committee (CEC) confirmed protocol-defined relapse, the total number of CEC confirmed protocol-defined relapses reaches 44, or 1.5 years after the last patient was randomized.. In the open-label extension period, the participant will receive satralizumab SC injection at Weeks 0, 2, and 4, and Q4W thereafter, up to the end of the study.

Outcomes

Primary Outcome Measures

Time to First Protocol-Defined Relapse (TFR) During the Double-Blind (DB) Period

TFR was defined as time from randomization to first occurrence of relapse in the DB period. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorder (NMOSD). Symptoms had to persist for >24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred < 31 days following onset of a protocol-defined relapse were considered part of same relapse (i.e., if 2 relapses had onset days that were 30 days of one another, they were counted only as 1 relapse), and onset date used in analysis was the date of first relapse.

Secondary Outcome Measures

Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain During the DB Period

The VAS is a subjective measure of pain consisting of a 100 mm line with two endpoints representing 0 = "no pain" and 100 = "pain as bad as it could be". Participants rated their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the "no pain" marker was measured with a ruler giving a pain score out of 100. A higher score indicated more pain and lower scores reflected a better health state. A negative change from baseline indicates an improvement. ANCOVA was used for analysis to report the adjusted mean and standard error (SE).

Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale During the DB Period

The FACIT Fatigue scale is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. As each of the 13 items of the scale ranges from 0-4, the range of possible scores was computed using FACIT scoring algorithm as 0-52, where 0 is the worst possible score and 52 the best which indicated less fatigue. A positive change from baseline indicates an improvement.

Relapse-Free Rate During the DB Period

Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorder (NMOSD). Symptoms had to persist for >24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred < 31 days following onset of a protocol-defined relapse were considered part of same relapse (i.e., if 2 relapses had onsets within 30 days of one another, they were counted as 1), and onset date used in analysis was the date of first relapse.

Annualized Relapse Rate (ARR) During the DB Period

The ARR is calculated as the total number of participants with adjudicated PDRs experienced divided by the patient-years at risk. Protocol-defined relapse was occurrence of new or worsening neurological symptoms attributable to neurological NMO or NMOSD. Symptoms had to persist for >24 hours and not be attributable to confounding clinical factors (e.g., fever, infection, injury, change in mood, adverse reactions to medications). New or worsening neurological symptoms that occurred < 31 days following onset of a protocol-defined relapse were considered part of same relapse (2 relapses with onset days in 30 days of one another was counted as 1 relapse), onset date used in analysis was the date of first relapse.

Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period

The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health component summary measures and a preference-based health utility index. The domain scores were transformed to a 0-100 scale, where higher scores indicate better quality of life. A positive change from baseline indicates an improvement.

Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period

Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period

Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period

Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period

Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period

Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period

Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period

Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period

The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health summary measures and a preference-based health utility index. The component scores were transformed to a 0-100 scale, where higher score indicates better quality of life. A positive change from baseline indicates an improvement.

Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period

The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health summary measures and a preference-based health utility index. The component scores were transformed to a 0-100 scale, where higher score indicates better quality of life. A positive change from baseline indicates an improvement.

Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period

The EQ-5D is a participant-answered questionnaire measuring 5 dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 possible response categories: 1) no problems; 2) some problems; 3) severe problems. The scores from 5 dimensions are used as input to generate EQ-5D index score using scoring algorithm. The EQ-5D index score is scored on a scale of -0.2 to 1. A higher score reflects a better health state. A positive change from baseline indicates an improvement

Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period

The T25W is an assessment of walking ability. The time (in seconds) that the participant took to walk 25 feet was measured. Speed is calculated as 1/Timed 25-Foot Walk where time is measured in seconds. A positive change from baseline indicates an improvement.

Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period

The mRS is a 7-point disability scale that assesses the degree of disability in participants with neurological impairment. Possible scores range from 0 (no symptoms at all) up to 6 (death). Higher scores reflect increased disability. A negative change from baseline indicates an improvement.

Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period

The ZBI is the measurement to assess caregiver burden. The 22 items ask for the strain caregivers perceive. Responses range from 0 (never) to 4 (nearly always). The overall ZBI score ranges from 0 to 88. The higher the total score, the heavier the perceived burden. A negative change from baseline indicates an improvement.

Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period

The EDSS is an ordinal scale with values from 0 points (normal neurological examination) to 10 points (death) increasing in half-point increments once an EDSS of 1.0 has been reached. Higher scores represent increased disability. A negative change from baseline indicates an improvement.

Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period

Visual acuity was measured using Snellen 20-foot wall chart and then converted to logMAR visual acuity scoring. Lower values indicate better visual acuity. Data are reported for right eye (OD) and left eye (OS). A negative change from baseline indicates an improvement.

Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period

The LCSLC evaluates the visual function and captures the minimum size at which individuals can perceive letters of a particular contrast level. The change in binocular visual acuity, as assessed by the number of letters read correctly from a distance of 2 meters on 100%, 2.5% and 1.25% contrast level Sloan letter charts, was analyzed. The LCSLC is scored on a scale of 0-60. Higher scores indicate better visual function. A positive change from baseline indicates an improvement.

Number of Participants With at Least One Adverse Event in the DB Period

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.

Number of Participants With at Least One Serious Adverse Event in the DB Period

A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.

Number of Participants With Non-Serious Adverse Events of Special Interest in the DB Period

Non-serious adverse events of special interest for this study included: 1) cases of an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, 2) suspected transmission of an infectious agent by the study treatment.

Number of Participants With Selected Adverse Events in the DB Period

Selected adverse events for this study included: 1) all infections, 2) serious infections, 3) potential opportunistic infections, 4) injection-related reactions (IRRs; an AE which occured within 24 hours after study treatment injection except where the event was not considered an allergic reaction), 5) psychiatric disorders and 6) anaphylaxis (an acute allergic/hypersensitivity reaction).

Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period

The Columbia-Suicide Severity Rating Scale (C-SSRS) is an assessment tool to evaluate suicidal ideation and behavior. Categories have binary responses (yes/no) and include: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation or behavior is indicated by a "yes" answer to any of the listed categories. A score of 0 is assigned if no suicide risk is present. A score of 1 or higher indicates suicidal ideation or behavior.

Serum Satralizumab Concentration During the DB Period

Serum Interleukin-6 (IL-6) Concentration During the DB Period

Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period

Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period

Percentage of Participants With Anti-Drug Antibodies to Satralizumab in the DB Period

Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during the DB period.

Full Information

NCT ID

NCT02073279

First Posted

February 25, 2014

Last Updated

January 31, 2023

Sponsor

Hoffmann-La Roche

Collaborators

Chugai Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT02073279

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

August 5, 2014 (Actual)

Primary Completion Date

October 12, 2018 (Actual)

Study Completion Date

January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

Collaborators

Chugai Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objectives of this study are to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of satralizumab in participants with NMO and NMOSD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Satralizumab

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Satralizumab

Other Intervention Name(s)

SA237, RG6168

Intervention Description

Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).

Primary Outcome Measure Information:

Title

Time to First Protocol-Defined Relapse (TFR) During the Double-Blind (DB) Period

Description

Time Frame

Up to Week 216

Secondary Outcome Measure Information:

Title

Change From Baseline to Week 24 in Visual Analogue Scale (VAS) for Pain During the DB Period

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale During the DB Period

Description

Time Frame

Baseline, Week 24

Title

Relapse-Free Rate During the DB Period

Description

Time Frame

Up to Week 216

Title

Annualized Relapse Rate (ARR) During the DB Period

Description

Time Frame

Up to Week 216

Title

Change From Baseline in Short Form Generic Health Survey (SF-36) Bodily Pain Domain Scores at 24 Week Intervals During the DB Period

Description

Time Frame

Baseline up to Week 216

Title

Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period

Description

Time Frame

Baseline up to Week 216

Title

Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period

Description

Time Frame

Baseline up to Week 216

Title

Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period

Description

Time Frame

Baseline up to Week 216

Title

Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period

Description

Time Frame

Baseline up to Week 216

Title

Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period

Description

Time Frame

Baseline up to Week 216

Title

Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period

Description

Time Frame

Baseline up to Week 216

Title

Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period

Description

Time Frame

Baseline up to Week 216

Title

Change From Baseline in SF-36 Mental Component Summary Scores at 24 Week Intervals During the DB Period

Description

The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health summary measures and a preference-based health utility index. The component scores were transformed to a 0-100 scale, where higher score indicates better quality of life. A positive change from baseline indicates an improvement.

Time Frame

Baseline up to Week 216

Title

Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period

Description

The SF-36v2 is a multi-purpose, short form health survey with 36 questions. It has 8 domains (vitality, physical functioning, bodily pain, general health, role-physical, role emotional, social role functioning and mental health) of functional health and well-being scores as well as psychometrically based physical and mental health summary measures and a preference-based health utility index. The component scores were transformed to a 0-100 scale, where higher score indicates better quality of life. A positive change from baseline indicates an improvement.

Time Frame

Baseline up to Week 216

Title

Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period

Description

Time Frame

Baseline up to Week 216

Title

Change From Baseline in Speed of Timed 25-Foot Walk (T25W) at 24 Week Intervals During the DB Period

Description

Time Frame

Baseline up to Week 216

Title

Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period

Description

Time Frame

Baseline up to Week 216

Title

Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period

Description

Time Frame

Baseline up to Week 120

Title

Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period

Description

Time Frame

Baseline up to Week 216

Title

Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period

Description

Time Frame

Baseline up to Week 216

Title

Change From Baseline in Visual Function (Low-Contrast Sloan Letter Chart [LCSLC]) Scores at 24 Week Intervals During the DB Period

Description

Time Frame

Baseline up to Week 216

Title

Number of Participants With at Least One Adverse Event in the DB Period

Description

Time Frame

Up to Week 216

Title

Number of Participants With at Least One Serious Adverse Event in the DB Period

Description

Time Frame

Up to Week 216

Title

Number of Participants With Non-Serious Adverse Events of Special Interest in the DB Period

Description

Time Frame

Up to Week 216

Title

Number of Participants With Selected Adverse Events in the DB Period

Description

Time Frame

Up to Week 216

Title

Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period

Description

Time Frame

Baseline and Post-Baseline (up to Week 216)

Title

Serum Satralizumab Concentration During the DB Period

Time Frame

Baseline, Weeks 2, 4, 5, 6, 8, and every 4 weeks thereafter up to Week 204

Title

Serum Interleukin-6 (IL-6) Concentration During the DB Period

Time Frame

Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216

Title

Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period

Time Frame

Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216

Title

Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period

Time Frame

Baseline, Weeks 2, 4, and every 4 weeks thereafter up to Week 216

Title

Percentage of Participants With Anti-Drug Antibodies to Satralizumab in the DB Period

Description

Reported here is the percentage of participants with at least one positive anti-drug antibody measurement during the DB period.

Time Frame

Up to approximately Week 216

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants must be diagnosed as having either neuromyelitis optica (NMO) or NMO spectrum disorder (NMOSD), defined as the following: 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) NMOSD as defined by either of following criteria with anti-aquaporin-4 (AQP4) antibody seropositive status at screening: i. Idiopathic single or recurrent events of longitudinally extensive myelitis (≥3 vertebral segment spinal cord MRI lesion); ii. Optic neuritis, single, recurrent or simultaneous bilateral Clinical evidence of at least 1 documented relapse (including first attack) in last 12 months prior to screening Expanded Disability Status Scale (EDSS) score from 0 to 6.5 inclusive at screening Age 18 to 74 years, inclusive at the time of informed consent Ability and willingness to provide written informed consent and to comply with the requirements of the protocol Exclusion Criteria: Clinical relapse onset (including first attack) within 30 days prior to baseline Exclusion Criteria Related to Previous or Concomitant Therapy: Any previous treatment with interleukin 6 (IL-6) inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation at any time Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline Any previous treatment with anti-CD4, cladribine, cyclophosphamide or mitoxantrone within 2 years prior to baseline Treatment with any investigational agent within 3 months prior to baseline Exclusions for General Safety: Pregnancy or lactation. For participants of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception (physical barrier [participants 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 Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML) Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; 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 Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline Evidence of chronic active hepatitis B or C History of drug or alcohol abuse within 1 year prior to baseline History of diverticulitis that, in the Investigator's opinion, may lead to increased risk of complications such as lower gastrointestinal perforation Evidence of active tuberculosis (excluding participants receiving chemoprophylaxis for latent tuberculosis infection) Evidence of active interstitial lung disease Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline History of malignancy within the last 5 years, including solid tumors, hematologic malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured) History of severe allergic reaction to a biologic agent (e.g., shock, anaphylactic reactions) Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening History of Stevens-Johnson syndrome Following laboratory abnormalities at screening*. White blood cells <3.0 x10^3/microliter (μL) Absolute neutrophil count <2.0 x 10^3 /μL Absolute lymphocyte count <0.5 x 10^3 /μL Platelet count <10 x 10^4 /μL Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal. If retest is conducted, the last value of retest before randomization must meet study criteria.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

University of Colorado Denver -; Neurology

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

University of Miami UHealth Professional Arts Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

The MS Center of Vero Beach

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32962

Country

United States

Facility Name

Columbus Research and Wellness

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31909

Country

United States

Facility Name

University of Chicago; Neurology

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Consultants in Neurology Ltd

City

Northbrook

State/Province

Illinois

ZIP/Postal Code

60062

Country

United States

Facility Name

OSF Saint Francis Medical Center

City

Peoria

State/Province

Illinois

ZIP/Postal Code

64637

Country

United States

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

MidAmerica Neuroscience Institute

City

Prairie Village

State/Province

Kansas

ZIP/Postal Code

66206

Country

United States

Facility Name

University of Michigan Health System

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-0666

Country

United States

Facility Name

Wayne State University - Comp Clinic and MS. Center

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

The Neurological Institute PA

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

OhioHealth Research Institute

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

University of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Central Texas Neurology Consultants

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Facility Name

UT Medicine San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23219-1901

Country

United States

Facility Name

Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53215

Country

United States

Facility Name

Medical Help Center EOOD

City

Dobrich

ZIP/Postal Code

9300

Country

Bulgaria

Facility Name

MMA-MHAT Pleven - Clinic for Neurology

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

UMHAT 'Dr. Georgi Stranski', EAD

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

MHATNP Sveti Naum EAD

City

Sofia

ZIP/Postal Code

1113

Country

Bulgaria

Facility Name

UMHAT Alexandrovska, EAD

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

MS Clinical Trials Group

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6T 1Z3

Country

Canada

Facility Name

Recherche Sepmus Inc.

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2J2

Country

Canada

Facility Name

Centre hospitalier de l'Universite de Montreal (CHUM)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 0A9

Country

Canada

Facility Name

Klinicki bolnicki centar Osijek

City

Osijek

ZIP/Postal Code

31000

Country

Croatia

Facility Name

LTD Helsicore

City

Tbilisi

ZIP/Postal Code

0112

Country

Georgia

Facility Name

Pineo Medical Ecosystem LTD

City

Tbilisi

ZIP/Postal Code

0114

Country

Georgia

Facility Name

S.Khechinashvili Tbilisi State Medical University Clinic Ne

City

Tbilisi

ZIP/Postal Code

0179

Country

Georgia

Facility Name

PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

City

Catania

State/Province

Sicilia

ZIP/Postal Code

95123

Country

Italy

Facility Name

Korea University Anam Hospital - Neurology

City

Seoul

ZIP/Postal Code

02841

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Asan Medical Center

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Severance Hospital - Yonsei University Health System - Neurology

City

Seoul

ZIP/Postal Code

3722

Country

Korea, Republic of

Facility Name

Hospital Universiti Sains Malaysia [Neurology]

City

Kubang Kerian

State/Province

Kelantan

ZIP/Postal Code

16150

Country

Malaysia

Facility Name

Hospital Kuala Lumpur

City

Kuala Lumpur

ZIP/Postal Code

50586

Country

Malaysia

Facility Name

Philippine General Hospital

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

City

Katowice

ZIP/Postal Code

40-123

Country

Poland

Facility Name

Miedzyleski Szpital Specjalistyczny w Warszawie

City

Warszawa

ZIP/Postal Code

04-749

Country

Poland

Facility Name

San Juan MS Center

City

Guaynabo

ZIP/Postal Code

00968

Country

Puerto Rico

Facility Name

SC Clubul Sanatatii SRL

City

Campulung

ZIP/Postal Code

115100

Country

Romania

Facility Name

China Medical University Healthcare System

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

National Cheng Kung University Hospital; Neurology

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Taipei Veterans General Hospital-Neurology

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Bilim University Medical Faculty Florence Nightingale Hospital

City

Istanbul

ZIP/Postal Code

34333

Country

Turkey

Facility Name

Ondokuz Mayis Univ. Med. Fac.

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Facility Name

Ivano-Frankivska oblasna klinichna likarnia

City

Ivano-Frankivsk

State/Province

KIEV Governorate

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

Ivano-Frankivska miska klinichna likarnia №1

City

Ivano-Frankivsk

State/Province

KIEV Governorate

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Kiev National Medical University

City

Kiev

State/Province

KIEV Governorate

ZIP/Postal Code

3110

Country

Ukraine

Facility Name

Municipal Foundation of Kyiv Regional Council " Kyiv Region

City

Kyiv

State/Province

KIEV Governorate

ZIP/Postal Code

4107

Country

Ukraine

Facility Name

Reginal clinical psyconeurological hospital

City

Ternopil

State/Province

KIEV Governorate

ZIP/Postal Code

46014

Country

Ukraine

Facility Name

Vinnytskyi natsionalnyi medychnyi universytet imeni M.I. Pyr

City

Vinnytsya

State/Province

Poltava Governorate

ZIP/Postal Code

21005

Country

Ukraine

Facility Name

Municipal Establishment "City Clinical Hospital #2; Neurology

City

Zaporozhya

State/Province

Poltava Governorate

ZIP/Postal Code

69068

Country

Ukraine

Facility Name

Miska Klinichna Likarnia №16

City

Dnipropetrovsk

State/Province

Tavria Okruha

ZIP/Postal Code

49100

Country

Ukraine

Facility Name

KU "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia"

City

Odesa

State/Province

Tavria Okruha

ZIP/Postal Code

65006

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

36007339

Citation

Yamamura T, Weinshenker B, Yeaman MR, De Seze J, Patti F, Lobo P, von Budingen HC, Kou X, Weber K, Greenberg B. Long-term safety of satralizumab in neuromyelitis optica spectrum disorder (NMOSD) from SAkuraSky and SAkuraStar. Mult Scler Relat Disord. 2022 Oct;66:104025. doi: 10.1016/j.msard.2022.104025. Epub 2022 Jul 5.

Results Reference

derived

PubMed Identifier

32333898

Citation

Traboulsee A, Greenberg BM, Bennett JL, Szczechowski L, Fox E, Shkrobot S, Yamamura T, Terada Y, Kawata Y, Wright P, Gianella-Borradori A, Garren H, Weinshenker BG. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial. Lancet Neurol. 2020 May;19(5):402-412. doi: 10.1016/S1474-4422(20)30078-8.

Results Reference

derived

Learn more about this trial

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

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