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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 2 March 2022
Main ID:  EUCTR2015-005431-41-HR
Date of registration: 15/12/2016
Prospective Registration: No
Primary sponsor: F. Hoffmann-La Roche Ltd.
Public title: A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder
Scientific 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)
Date of first enrolment: 30/11/2016
Target sample size: 12
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005431-41
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Bulgaria Canada Croatia Georgia Italy Korea, Republic of Malaysia Poland
Romania Taiwan Turkey Ukraine United States
Contacts
Name: Trial Information Support Line-TISL   
Address:  Grenzacherstrasse 124 4070 Basel Switzerland
Telephone:
Email: global.rochegenentechtrials@roche.com
Affiliation:  F. Hoffmann-La Roche Ltd.
Name: Trial Information Support Line-TISL   
Address:  Grenzacherstrasse 124 4070 Basel Switzerland
Telephone:
Email: global.rochegenentechtrials@roche.com
Affiliation:  F. Hoffmann-La Roche Ltd.
Key inclusion & exclusion criteria
Inclusion criteria:
Patients must meet the following criteria for study entry:
1. Patients must be diagnosed as either
a. NMO as defined by Wingerchuk 2006 criteria*, or
b. NMOSD as defined by either of the 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 magnetic resonance imaging [MRI] lesion)
ii. Optic neuritis, single, recurrent or simultaneous bilateral
2. Clinical evidence of at least 1 documented relapse (including first attack) in last 12 months prior to screening.
3. Expanded disability status scale (EDSS) score from 0 to 6.5 inclusive at screening.
4. Age 18 to 74 years, inclusive at the time of informed consent.
5. Ability and willingness to provide written informed consent and to comply with the requirements of the protocol.
*According to Wingerchuk et al. 2006, a diagnosis of NMO requires all of following criteria:
I. Optic neuritis
II. Acute myelitis
III. At least two of three supportive criteria:
• Contiguous spinal cord lesion identified on an MRI scan extending over 3 vertebral segments
• Brain MRI not meeting diagnostic criteria for multiple sclerosis
• NMO-Immunoglobulin G seropositive status

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
Exclusion Criteria Related to NMO:
1. Clinical relapse onset (including first attack) within 30 days prior to baseline.
Exclusion Criteria Related to Previous or Concomitant Therapy:
2. Any previous treatment with interleukin 6 (IL-6) inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation at any time.
3. 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.
4. Any previous treatment with anti-CD4, cladribine, cyclophosphamide or mitoxantrone within 2 years prior to baseline.
5. Treatment with any investigational agent within 3 months prior to baseline.
Exclusions for General Safety:
6. Pregnancy or lactation.
7. For patients of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing 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.
8. Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline.
9. Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML).
10. Evidence of serious uncontrolled concomitant diseases that may preclude patient 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
11. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.
12. Evidence of chronic active hepatitis B or C.
13. History of drug or alcohol abuse within 1 year prior to baseline.
14. History of diverticulitis that, in the Investigator’s opinion, may lead to increased risk of complications such as lower gastrointestinal perforation.
15. Evidence of active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection).
16. Evidence of active interstitial lung disease.
17. Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline.
18. 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).
19. History of severe allergic reaction to a biologic agent (e.g., shock, anaphylactic reactions).
20. Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening.
21. History of Stevens-Johnson syndrome.
Laboratory Exclusion criteria (at screening):
22. Following laboratory abnormalities at screening*.
a. White blood cells < 3.0 x103 /µL
b. Absolute neutrophil count < 2.0 x 103 /µL
c. Absolute lymphocyte count < 0.5 x 103 /µL
d. Platelet count < 10 x 104 /µL
e. 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 randomiza


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0 Level: LLT Classification code 10029322 Term: Neuromyelitis optica System Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Product Name: Satralizumab (120 mg/vial)
Product Code: Satralizumab (RO5333787/SA237)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Satralizumab (r-INN)
CAS Number: 1535963-91-7
Current Sponsor code: Satralizumab (RO5333787/SA237)
Other descriptive name: RO5333787
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: Satralizumab (120 mg/PFS with NSD)
Product Code: Satralizumab (RO5333787/SA237)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Satralizumab (r-INN)
CAS Number: 1535963-91-7
Current Sponsor code: Satralizumab (RO5333787/SA237)
Other descriptive name: RO5333787
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)
Timepoint(s) of evaluation of this end point: Time to first protocol-defined relapse (TFR) in the double-blind period.
Main Objective: To evaluate the efficacy and safety of SA237 monotherapy in patients with neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD).
Primary end point(s): Primary endpoint:
Time to first protocol-defined relapse (TFR) in the double-blind period.
Secondary Objective: Not applicable
Secondary Outcome(s)
Secondary end point(s): Secondary endpoints:
i. Change in Visual Analogue Scale (VAS) score for pain
ii. Change in Functional Assessment Of Chronic Illness Therapy (FACIT) Fatigue score
iii. Change in Short Form Generic Health Survey (SF-36) score
iv. Change in EQ-5D score
v. Change in Timed 25-Foot Walk (T25W)
vi. The proportion of relapse-free patients
vii. Annualized relapse rate (ARR)
viii. Change in modified Rankin Scale (mRS) score
ix. Change in Zarit Burden Interview (ZBI) score
x. Change in EDSS scores
xi. Change in visual acuity (Snellen chart)
xii. Change in low-contrast visual acuity (low-contrast Sloan letter chart [LCSLC])
Exploratory endpoint:
i. MRI scans of the brain, optic nerve and spinal cord
MRI for exploratory evaluation is optional and will be conducted at selected sites.
Pharmacokinetic/Pharmacodynamic Outcome Measures:
i. Serum SA237 concentration, IL-6, soluble IL-6 receptor (sIL-6R), high sensitivity C-reactive protein (hsCRP), anti-AQP4 antibody, plasmablast
Immunogenicity Outcome Measures:
i. Incidence of anti-SA237 antibodies
ii. PK, PD, clinical response, and safety during the study by anti-SA237 antibody status
Timepoint(s) of evaluation of this end point: Selected time points
Secondary ID(s)
2015-005431-41-PL
BN40900(SA-309JG)
NCT02073279
Source(s) of Monetary Support
F. Hoffmann-La Roche Ltd.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 03/11/2016
Contact:
Results
Results available: Yes
Date Posted: 27/09/2020
Date Completed:
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-005431-41/results
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