Clinical Trials List
Protocol NumberSA-309JG
2016-11-16 - 2020-01-31
Phase III
Terminated2
Study ended1
ICD-10G36.0
Neuromyelitis optica [Devic]
ICD-9341.0
Neuromyelitis optica
A multicenter, randomized, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 as monotherapy in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD).
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Trial Applicant
Chugai Pharma Taiwan Ltd.
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Sponsor
Chugai Pharma Taiwan Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 蔡清標 Division of Neurology
- Kon-Ping Lin Division of Neurology
- Yi-Chun Lee Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chou-Ching Lin Division of Neurology
- Yuan-Ting Sun Division of Neurology
- Han-Wei Huang Division of Neurology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- Kang-Hsu Lin Division of Neurology
- Yu-Wan Yang Division of Neurology
- Chung-Hsiang Liu Division of Neurology
The Actual Total Number of Participants Enrolled
1 Study ended
Condition/Disease
neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD)
Objectives
To evaluate the efficacy and safety of SA237 monotherapy in patients with
neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD).
Test Drug
SA237
Active Ingredient
SA237
Dosage Form
solution for injection, SC
Dosage
120mg/1ml
Endpoints
Primary endpoint
i. Time to first protocol-defined relapse (TFR) in the double-blind period
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.
i. Time to first protocol-defined relapse (TFR) in the double-blind period
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.
Inclution 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 following criteria with anti-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
2. Clinical evidence of at least 1 documented relapse (including first attack) in the last 12 months prior to screening.
3. 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-IgG seropositive status
Exclusion Criteria
Patients who meet any of the following criteria will be excluded from study entry:
Exclusion Criteria Related to Neuromyelitis Optica:
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 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 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.
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 following criteria with anti-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
2. Clinical evidence of at least 1 documented relapse (including first attack) in the last 12 months prior to screening.
3. 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-IgG seropositive status
Exclusion Criteria
Patients who meet any of the following criteria will be excluded from study entry:
Exclusion Criteria Related to Neuromyelitis Optica:
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 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 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.
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.
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.
The Estimated Number of Participants
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Taiwan
5 participants
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Global
90 participants
