Clinical trial NCT01892345
Conditions: Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder
Keywords: Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder Devic's disease, Transverse Myelitis Optic Neuritis relapse eculizumab soliris NMO-IgG CNS Autoimmune Disorders Demyelinating Disorders NMO NMOSD
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2014-04-11; Completion date: 2018-07-17
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this time-to-event study were to assess the efficacy and safety of eculizumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were anti-aquaporin-4 (AQP4) antibody-positive.

Detailed description:

Arms: arm 1: Biological/Vaccine: Eculizumab; Induction Period: Participants received eculizumab (900 milligrams \[mg\]) via intravenous (IV) infusion once a week (every 7 ± 2 days) for 4 weeks followed by eculizumab 1200 mg for the fifth dose (Week 4). This was followed by the Maintenance Period: Participants received eculizumab (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards. arm 2: Placebo contains the same buffer components without the active ingredient. Induction Period: Participants received matching placebo (900 mg) via IV infusion once a week (every 7 ± 2 days) for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose (Week 4). This was followed by the Maintenance Period: Participants received matching placebo (1200 mg) via IV infusion every 2 weeks (every 14 ± 2 days) from the sixth dose (Week 6) onwards.
Interventions: intervention 1: Eculizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Induction Phase: 900 mg IV weekly for 4 weeks, followed by 1200 mg for the fifth dose; Maintenance Phase: 1200 mg IV every 2 weeks intervention 2: Induction Phase: matching placebo (900 mg) IV weekly for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose; Maintenance Phase: matching placebo (1200 mg) IV every 2 weeks

Protocol documents:
Prot_000.pdf: 
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Protocol ECU-NMO-301 
 
Alexion Pharmaceuticals, Inc. 
Version 6.0 
 
01 July 2016 
Figure 1: 
Relationship between Serum Concentration of Eculizumab and Free C5 Inhibition 
 
 
Figure 2: 
Relationship between Serum Concentration of Eculizumab and Percent Hemolysis 
(Induction and Maintenance Periods) 
 
 
Ecu
l
izumab Concentrat
ions (g/mL)
Free C5 (g/mL)
0
20
40
60
80
100
120
0
100
200
300
400
500
600
700
800
C08-002A/B
C08-003A/B
C09-001r
Ecu
l
izumab Concentrat
ions (g/mL)
Hemolysis (%)
0
20
40
60
80
100
0
100
200
300
400
500
600
700
800
C08-002A/B
C08-003A/B
C09-001r
CONFIDENTIAL 
 
Page 33 of 122 


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Protocol ECU-NMO-301 
 
Alexion Pharmaceuticals, Inc. 
Version 6.0 
 
01 July 2016 
APPENDIX 5. HAUSER AMBULATION INDEX (33) 
 
� 0 = Asymptomatic; fully active. 
� 1 = Walks normally, but reports fatigue that interferes with athletic or other demanding activities. 
� 2 = Abnormal gait or episodic imbalance; gait disorder is noticed by family and friends; able to 
walk 25 feet (8 meters) in 10 seconds or less. 
� 3 = Walks independently; able to walk 25 feet in 20 seconds or less. 
� 4 = Requires unilateral support (cane or single crutch) to walk; walks 25 feet in   20 seconds or 
less. 
� 5 = Requires bilateral support (canes, crutches, or walker) and walks 25 feet in 20 seconds or 
less; or requires unilateral support but needs more than 20 seconds to walk 25 feet. 
� 6 = Requires bilateral support and more than 20 seconds to walk 25 feet; may use wheelchair* on 
occasion. 
� 7 = Walking limited to several steps with bilateral support; unable to walk 25 feet; may use 
wheelchair* for most activities. 
� 8 = Restricted to wheelchair; able to transfer self independently. 
� 9 = Restricted to wheelchair; unable to transfer self independently. 
*The use of a wheelchair may be determined by lifestyle and motivation. It is expected that 
patients in Grade 7 will use a wheelchair more frequently than those in Grades 5 or 6. 
Assignment of a grade in the range of 5 to 7, however, is determined by the patient’s ability to 
walk a given distance, and not by the extent to which the patient uses a wheelchair. 
 
 
 
 
 
CONFIDENTIAL 
 
Page 107 of 122 


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US TTO value set 
Example: the value for health state 21232 
Full health (11111)                           1  
 
Mobility = 2                                    -0.146 
Mobility = 3                                    -0.558 
 
Self care = 2                                    -0.175 
Self care = 3                                    -0.471 
 
Usual activities = 2                         -0.140 
Usual activities = 3                         -0.374 
 
Pain/discomfort = 2                        -0.173 
Pain discomfort = 3                        -0.537 
 
Anxiety/depression = 2                  -0.156 
Anxiety / depression = 3                -0.450 
 
Full health =                                    1 
 
Minus MO level 2                         -0.146 
 
 
Minus SC level 1                           -0.000 
 
 
Minus UA level 2                          -0.140 
 
 
Minus PD level 3                          -0.537 
 
 
Minus AD level 2                          -0.156 
 
 


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D1                                                  +0.140 
 
I2-square                                         -0.011 
 
I3                                                    +0.122 
 
I3-square                                        +0.015 
 
 
Plus D1                                    +3*0.140 
 
Minus I2-square                        -4*0.011 
 
Plus I3                                       +0*0.122 
 
Plus I3-square                           +0*0.015 
 
State 21232 = 0.397 
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