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A Double-masked, Placebo-controlled Study With Open Label Period to Evaluate MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02200770
Recruitment Status : Active, not recruiting
First Posted : July 25, 2014
Results First Posted : December 26, 2019
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
Interventions Drug: Inebilizumab
Other: Placebo
Enrollment 231
Recruitment Details The study was conducted in 24 countries.
Pre-assignment Details A total of 467 participants were screened in the study, out of which 236 were screen failures. A total of 231 participants were randomized in this study. The results of this study are posted per the data of primary completion date (26Oct2018).
Arm/Group Title Total Placebo Total Inebilizumab
Hide Arm/Group Description Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received intravenous (IV) dose of placebo matched to inebilizumab on Day 1 and Day 15 of the randomized-controlled period (RCP). The participants who entered open-label period (OLP) received IV inebilizumab 300 mg on both Day 1 and Day 15 in OLP; followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15 of OLP; followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP.
Period Title: Randomized-controlled Period (RCP)
Started 56 175
Treated 56 174
Completed 54 169
Not Completed 2 6
Reason Not Completed
Adverse Event             0             2
Withdrawal by Subject             1             1
Not treated             0             1
Other             1             2
Period Title: Open-label Period (OLP)
Started 51 [1] 162 [2]
Completed 0 0
Not Completed 51 162
Reason Not Completed
Participants ongoing             51             162
[1]
Enrolment into OLP was optional; out of 54 participants who completed RCP, only 51 entered in OLP.
[2]
Enrolment into OLP was optional; out of 169 participants who completed RCP, only 162 entered in OLP.
Arm/Group Title Total Placebo Total Inebilizumab Total
Hide Arm/Group Description Aquaporin-4-antibody (AQP4-IgG) sero positive and sero negative participants received intravenous (IV) dose of placebo matched to inebilizumab on Day 1 and Day 15 of the randomized-controlled period (RCP). The participants who entered open-label period (OLP) received IV inebilizumab 300 mg on both Day 1 and Day 15 in OLP; followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of RCP. The participants who entered OLP received IV inebilizumab 300 mg on Day 1 and matching placebo on Day 15 of OLP; followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP. Total of all reporting groups
Overall Number of Baseline Participants 56 174 230
Hide Baseline Analysis Population Description
ITT population included all participants who were randomized and grouped according to their randomized treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 174 participants 230 participants
42.6  (13.9) 43.0  (11.6) 42.9  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 174 participants 230 participants
Female
50
  89.3%
159
  91.4%
209
  90.9%
Male
6
  10.7%
15
   8.6%
21
   9.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 174 participants 230 participants
Hispanic or Latino
15
  26.8%
28
  16.1%
43
  18.7%
Not Hispanic or Latino
41
  73.2%
146
  83.9%
187
  81.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 174 participants 230 participants
AMERICAN INDIAN OR ALASKA NATIVE
5
   8.9%
14
   8.0%
19
   8.3%
ASIAN
8
  14.3%
39
  22.4%
47
  20.4%
BLACK OR AFRICAN AMERICAN
5
   8.9%
15
   8.6%
20
   8.7%
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
0
   0.0%
0
   0.0%
0
   0.0%
WHITE
28
  50.0%
92
  52.9%
120
  52.2%
OTHER
10
  17.9%
13
   7.5%
23
  10.0%
MULTIPLE CATEGORIES CHECKED
0
   0.0%
1
   0.6%
1
   0.4%
1.Primary Outcome
Title Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During Randomized Controlled Period (RCP)
Hide Description The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide. Only attacks positively adjudicated by the AC were used for the primary analysis.
Time Frame Day 1 (Baseline) through Day 197
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized and grouped according to their randomized treatment.
Arm/Group Title Total Placebo Total Inebilizumab
Hide Arm/Group Description:
AQP4-IgG sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the study.
AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of the study.
Overall Number of Participants Analyzed 56 174
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(142.0 to NA)
NA [1] 
(NA to NA)
[1]
Median is not reported as there were insufficient events to determine the median.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Placebo, Total Inebilizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.272
Confidence Interval (2-Sided) 95%
0.1496 to 0.4961
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP
Hide Description EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.
Time Frame Day 1 (Baseline) through Day 197
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized and grouped according to their randomized treatment.
Arm/Group Title Total Placebo Total Inebilizumab
Hide Arm/Group Description:
AQP4-IgG sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the study.
AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of the study.
Overall Number of Participants Analyzed 56 174
Measure Type: Number
Unit of Measure: Percentage of Participants
33.9 15.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Placebo, Total Inebilizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0049
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.370
Confidence Interval (2-Sided) 95%
0.1850 to 0.7389
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the Last Visit of RCP
Hide Description Low-contrast visual acuity test is used to determine the number of letters that can be read on a standardized low-contrast Landolt C Broken Rings Chart held at a distance of 3 meters. Binocular score is the number of letters read correctly on an eye chart using both eyes simultaneously. The total score ranges from 0-70. Higher score indicates better vision.
Time Frame Day 1 (Baseline) through Day 197
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized and grouped according to their randomized treatment. Participants with low contrast visual acuity binocular score were analyzed for this outcome measure.
Arm/Group Title Total Placebo Total Inebilizumab
Hide Arm/Group Description:
AQP4-IgG sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the study.
AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of the study.
Overall Number of Participants Analyzed 56 171
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
1.442  (1.217) 1.576  (0.935)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Placebo, Total Inebilizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9026
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.134
Confidence Interval (2-Sided) 95%
-2.0254 to 2.2941
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.096
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions During RCP
Hide Description The number of new gadolinium-enhancing lesions and new or enlarging T2 lesions were measured by MRI of the brain, optic nerve, and spinal cord.
Time Frame From Screening (Day -28) to Day 197
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized and grouped according to their randomized treatment. Participants with observed MRI lesions were analyzed for this outcome measure.
Arm/Group Title Total Placebo Total Inebilizumab
Hide Arm/Group Description:
AQP4-IgG sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the study.
AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of the study.
Overall Number of Participants Analyzed 32 79
Mean (Standard Deviation)
Unit of Measure: Number of lesions
2.3  (1.3) 1.6  (1.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Placebo, Total Inebilizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0034
Comments [Not Specified]
Method Negative Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.566
Confidence Interval (2-Sided) 95%
0.3866 to 0.8279
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of NMOSD-related In-patient Hospitalizations During RCP
Hide Description Participants with relapsing NMOSD have recurrent attacks that can be severe and result in blindness, paralysis, and even death and consequently, such attacks frequently result in in-patient hospitalizations. In-patient hospitalization is defined as a stay in hospital that goes beyond midnight of the first day of admission.
Time Frame Day 1 (Baseline) through Day 197
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized and grouped according to their randomized treatment. Participants with in-patient hospitalization were analyzed for this outcome measure.
Arm/Group Title Total Placebo Total Inebilizumab
Hide Arm/Group Description:
AQP4-IgG sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the study.
AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of the study.
Overall Number of Participants Analyzed 8 10
Mean (Standard Deviation)
Unit of Measure: Number of In-patient Hospitalizations
1.4  (0.7) 1.0  (0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Placebo, Total Inebilizumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0100
Comments [Not Specified]
Method Negative Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.286
Confidence Interval (2-Sided) 95%
0.1105 to 0.7411
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Annualized AC-determined NMOSD Attack Rate During Any Exposure to Inebilizumab
Hide Description Annualized attack rate is defined as total number of AC-determined attacks divided by total person years. Total person-years is calculated as the sum of the person-years for individual participant. Person-year for individual participant = (Date of last day before safety follow-up period - first inebilizumab dose date +1)/365.25. Annualized AC-determined NMOSD attack rate during any exposure to inebilizumab (in RCP and OLP) is reported.
Time Frame For participants randomized to inebilizumab: Day 1 of RCP through end of OLP (approximately 3.5 years); and for participants randomized to placebo: Day 1 of OLP through the end of OLP (approximately 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Any inebilizumab population included all participants who received at least one dose of inebilizumab either in the RCP or OLP.
Arm/Group Title Any Inebilizumab
Hide Arm/Group Description:
AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 in RCP or IV inebilizumab 300 mg on both Day 1 and Day 15 in OLP ; followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP.
Overall Number of Participants Analyzed 225
Measure Type: Number
Unit of Measure: Annualized attack rate
0.126
7.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) During RCP
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the RCP.
Time Frame Day 1 (Baseline) through Day 197
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment received.
Arm/Group Title Total Placebo Total Inebilizumab
Hide Arm/Group Description:
AQP4-IgG sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the study.
AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of the study.
Overall Number of Participants Analyzed 56 174
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
41
  73.2%
125
  71.8%
TESAEs
5
   8.9%
8
   4.6%
8.Secondary Outcome
Title Number of Participants With TEAEs and TESAEs During OLP
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP.
Time Frame Day 198 through end of OLP period (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population included all participants who received at least one dose of study drug during OLP.
Arm/Group Title Placebo/Inebilizumab Inebilizumab/Inebilizumab
Hide Arm/Group Description:
Sero positive and sero negative participants who received inebilizumab in RCP received IV dose of inebilizumab 300 mg on Day 1 and matching placebo on Day 15 during the OLP; followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP.
Sero positive and sero negative participants who received placebo in RCP received IV dose of inebilizumab 300 mg on both Day 1 and Day 15; followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP.
Overall Number of Participants Analyzed 51 162
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
37
  72.5%
108
  66.7%
TESAEs
8
  15.7%
13
   8.0%
9.Secondary Outcome
Title Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During RCP
Hide Description Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during RCP is reported.
Time Frame Day 1 (Baseline) through Day 197
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment received. Here, number analyzed "n" signifies participants who were analyzed for the specified parameter.
Arm/Group Title Total Placebo Total Inebilizumab
Hide Arm/Group Description:
AQP4-IgG sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the study.
AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of the study.
Overall Number of Participants Analyzed 56 174
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin (decreased) Number Analyzed 56 participants 173 participants
0
   0.0%
2
   1.2%
Leukocytes (decreased) Number Analyzed 56 participants 173 participants
1
   1.8%
11
   6.4%
Lymphocytes (decreased) Number Analyzed 56 participants 173 participants
5
   8.9%
35
  20.2%
Lymphocytes (increased) Number Analyzed 56 participants 173 participants
4
   7.1%
1
   0.6%
Neutrophils (decreased) Number Analyzed 56 participants 173 participants
0
   0.0%
9
   5.2%
Alanine Aminotransferase (increased) Number Analyzed 56 participants 173 participants
1
   1.8%
4
   2.3%
Aspartate Aminotransferase (increased) Number Analyzed 56 participants 173 participants
2
   3.6%
1
   0.6%
Bilirubin (increased) Number Analyzed 56 participants 173 participants
2
   3.6%
1
   0.6%
Cholesterol (increased) Number Analyzed 56 participants 173 participants
2
   3.6%
5
   2.9%
Creatinine (increased) Number Analyzed 56 participants 173 participants
1
   1.8%
5
   2.9%
Gamma glutamyl transferase (increased) Number Analyzed 56 participants 173 participants
1
   1.8%
6
   3.5%
Glucose (decreased) Number Analyzed 56 participants 173 participants
1
   1.8%
1
   0.6%
Glucose (increased) Number Analyzed 56 participants 173 participants
5
   8.9%
1
   0.6%
Potassium (decreased) Number Analyzed 56 participants 173 participants
0
   0.0%
1
   0.6%
Sodium (decreased) Number Analyzed 56 participants 173 participants
1
   1.8%
2
   1.2%
Triglycerides (increased) Number Analyzed 56 participants 173 participants
2
   3.6%
7
   4.0%
10.Secondary Outcome
Title Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During OLP
Hide Description Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during OLP is reported.
Time Frame Day 198 through end of OLP (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label population included all participants who received at least one dose of study drug during OLP. Here, number analyzed "n" signifies participants who were analyzed for the specified parameter.
Arm/Group Title Placebo/Inebilizumab Inebilizumab/Inebilizumab
Hide Arm/Group Description:
Participants who received placebo in RCP received IV dose of inebilizumab 300 mg on both Day 1 and Day 15; followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP.
Participants who received inebilizumab in RCP received IV dose of inebilizumab 300 mg on Day 1 and matching placebo on Day 15; followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP.
Overall Number of Participants Analyzed 51 162
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin (decreased) Number Analyzed 49 participants 156 participants
0
   0.0%
3
   1.9%
Leukocytes (decreased) Number Analyzed 49 participants 156 participants
0
   0.0%
9
   5.8%
Lymphocytes (decreased) Number Analyzed 49 participants 156 participants
9
  18.4%
14
   9.0%
Lymphocytes (increased) Number Analyzed 49 participants 156 participants
1
   2.0%
2
   1.3%
Neutrophils (decreased) Number Analyzed 49 participants 156 participants
0
   0.0%
11
   7.1%
Alanine aminotransferase (increased) Number Analyzed 49 participants 156 participants
2
   4.1%
1
   0.6%
Albumin (decreased) Number Analyzed 49 participants 156 participants
0
   0.0%
1
   0.6%
Alkaline phosphatase (increased) Number Analyzed 49 participants 156 participants
0
   0.0%
1
   0.6%
Aspartate aminotransferase (increased) Number Analyzed 49 participants 156 participants
0
   0.0%
1
   0.6%
Cholesterol (increased) Number Analyzed 49 participants 156 participants
0
   0.0%
3
   1.9%
Creatinine (increased) Number Analyzed 49 participants 156 participants
1
   2.0%
5
   3.2%
Gamma glutamyl transferase (increased) Number Analyzed 49 participants 156 participants
1
   2.0%
6
   3.8%
Glucose (decreased) Number Analyzed 49 participants 156 participants
0
   0.0%
2
   1.3%
Glucose (increased) Number Analyzed 49 participants 156 participants
5
  10.2%
1
   0.6%
Potassium (decreased) Number Analyzed 49 participants 156 participants
0
   0.0%
1
   0.6%
Potassium (increased) Number Analyzed 49 participants 156 participants
0
   0.0%
1
   0.6%
Sodium (decreased) Number Analyzed 49 participants 156 participants
1
   2.0%
0
   0.0%
Triglycerides (increased) Number Analyzed 49 participants 156 participants
3
   6.1%
2
   1.3%
Urate (increased) Number Analyzed 49 participants 156 participants
1
   2.0%
1
   0.6%
11.Secondary Outcome
Title Time to Maximum Serum Concentration (Tmax) of Inebilizumab (During RCP)
Hide Description Time to maximum serum concentration of inebilizumab during RCP is reported.
Time Frame Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized and grouped according to their randomized treatment. Out of overall "number of participants analyzed", only participants who had adequate pharmacokinetic sample of inebilizumab per specified dose levels (Dose 1 and Dose 2) were analyzed.
Arm/Group Title Total Inebilizumab
Hide Arm/Group Description:
AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of the study.
Overall Number of Participants Analyzed 174
Median (Full Range)
Unit of Measure: Days
Dose 1 Number Analyzed 173 participants
0.07
(0.07 to 7.00)
Dose 2 Number Analyzed 168 participants
0.07
(0.07 to 14.00)
12.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of Inebilizumab (During RCP)
Hide Description Maximum observed serum concentration of inebilizumab during RCP is reported.
Time Frame Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized and grouped according to their randomized treatment. Out of overall "number of participants analyzed", only participants who had adequate pharmacokinetic sample of inebilizumab per specified dose levels (Dose 1 and Dose 2) were analyzed.
Arm/Group Title Total Inebilizumab
Hide Arm/Group Description:
AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of the study.
Overall Number of Participants Analyzed 174
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
Dose 1 Number Analyzed 173 participants
97.7
(37.4%)
Dose 2 Number Analyzed 168 participants
108
(45.4%)
13.Secondary Outcome
Title Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab (During RCP)
Hide Description Area under the serum concentration time curve of the dosing interval (AUC0-14d) of inebilizumab during RCP is reported.
Time Frame Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized and grouped according to their randomized treatment. Out of overall "number of participants analyzed", only participants who had adequate pharmacokinetic sample of inebilizumab per specified dose levels (Dose 1 and Dose 2) were analyzed.
Arm/Group Title Total Inebilizumab
Hide Arm/Group Description:
AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of the study.
Overall Number of Participants Analyzed 174
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg*d/mL
Dose 1 Number Analyzed 167 participants
667
(31.3%)
Dose 2 Number Analyzed 164 participants
967
(39.6%)
14.Secondary Outcome
Title Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During RCP)
Hide Description Number of participants with positive ADA titer to inebilizumab during RCP is reported.
Time Frame Pre and post dose on Day 1; and on Days 29, 85, and 197
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Hide Analysis Population Description
The ITT population included all participants who were randomized and grouped according to their randomized treatment.
Arm/Group Title Total Placebo Total Inebilizumab
Hide Arm/Group Description:
AQP4-IgG sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the study.
AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of the study.
Overall Number of Participants Analyzed 56 174
Measure Type: Count of Participants
Unit of Measure: Participants
ADA positive at anytime including baseline (BL) Number Analyzed 56 participants 174 participants
8
  14.3%
17
   9.8%
ADA positive at BL; not detected post-BL Number Analyzed 56 participants 174 participants
0
   0.0%
5
   2.9%
ADA positive post-BL; positive at BL Number Analyzed 56 participants 174 participants
4
   7.1%
7
   4.0%
ADA positive post-BL; not detected at BL Number Analyzed 56 participants 74 participants
4
   7.1%
5
   6.8%
15.Secondary Outcome
Title Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (RCP+OLP)
Hide Description Number of participants with positive ADA titer to inebilizumab in RCP and OLP (combined) is reported.
Time Frame RCP: Pre and post dose on Day 1; and on Days 29, 85, and 197; OLP: Pre and post dose on Day 1; and on Days 92, 183, 274, and then every 6 months until maximum of 3 years
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Hide Analysis Population Description
Any inebilizumab population included all participants who received at least one dose of inebilizumab either in the RCP or OLP.
Arm/Group Title Any Inebilizumab
Hide Arm/Group Description:
AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 in RCP or IV inebilizumab 300 mg on both Day 1 and Day 15 in OLP ; followed by a single IV dose of inebilizumab 300 mg every 6 months until maximum of 3 years after the last participant enters the OLP.
Overall Number of Participants Analyzed 225
Measure Type: Count of Participants
Unit of Measure: Participants
ADA positive at any time including baseline (BL)
30
  13.3%
ADA positive at BL; not detected post-BL
8
   3.6%
ADA positive post-BL and positive at BL
11
   4.9%
ADA positive post-BL; not detected at BL
10
   4.4%
Time Frame Day 1 (Baseline) through end of OLP period (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Total Placebo Total Inebilizumab
Hide Arm/Group Description AQP4-IgG sero positive and sero negative participants received IV dose of placebo matched to inebilizumab on Day 1 and Day 15 of the study. AQP4-IgG sero positive and sero negative participants received IV dose of inebilizumab 300 mg on Day 1 and Day 15 of the study.
All-Cause Mortality
Total Placebo Total Inebilizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)      0/174 (0.00%)    
Hide Serious Adverse Events
Total Placebo Total Inebilizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/56 (8.93%)      8/174 (4.60%)    
Eye disorders     
Vision blurred  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Visual acuity reduced  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea  1  0/56 (0.00%)  0 1/174 (0.57%)  1
General disorders     
Chest pain  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Hepatobiliary disorders     
Cholangitis acute  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Cholecystitis acute  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Hepatic function abnormal  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Infections and infestations     
Atypical pneumonia  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Meningitis viral  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Myelitis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Pneumonia  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Septic shock  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Urinary tract infection  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Injury, poisoning and procedural complications     
Burns third degree  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Metabolism and nutrition disorders     
Hypoglycaemia  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Nervous system disorders     
Migraine  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/56 (1.79%)  2 0/174 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Total Placebo Total Inebilizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/56 (71.43%)      125/174 (71.84%)    
Blood and lymphatic system disorders     
Anaemia  1  2/56 (3.57%)  2 6/174 (3.45%)  6
Iron deficiency anaemia  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Leukocytosis  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Leukopenia  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Lymphadenopathy  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Lymphopenia  1  0/56 (0.00%)  0 3/174 (1.72%)  3
Neutropenia  1  0/56 (0.00%)  0 4/174 (2.30%)  4
Neutrophilia  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Cardiac disorders     
Arrhythmia  1  1/56 (1.79%)  1 1/174 (0.57%)  1
Sinus bradycardia  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Sinus tachycardia  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Ear and labyrinth disorders     
Ear pain  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Ear pruritus  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Tinnitus  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Vertigo  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Vertigo positional  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Endocrine disorders     
Adrenal insufficiency  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Hyperthyroidism  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Eye disorders     
Blepharitis  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Blepharospasm  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Eye inflammation  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Eye irritation  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Eye pain  1  1/56 (1.79%)  1 5/174 (2.87%)  12
Eye pruritus  1  1/56 (1.79%)  1 1/174 (0.57%)  1
Ocular discomfort  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Ocular hyperaemia  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Photophobia  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Vision blurred  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Gastrointestinal disorders     
Abdominal discomfort  1  1/56 (1.79%)  1 1/174 (0.57%)  1
Abdominal distension  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Abdominal pain  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Abdominal pain lower  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Abdominal pain upper  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Constipation  1  2/56 (3.57%)  2 0/174 (0.00%)  0
Dental caries  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Diarrhoea  1  3/56 (5.36%)  3 7/174 (4.02%)  9
Dry mouth  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Dyspepsia  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Enteritis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Enterocolitis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Gastritis  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Gastrooesophageal reflux disease  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Ileus  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Irritable bowel syndrome  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Nausea  1  3/56 (5.36%)  3 6/174 (3.45%)  6
Oral mucosal blistering  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Pancreatitis acute  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Proctalgia  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Sensitivity of teeth  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Toothache  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Vomiting  1  4/56 (7.14%)  4 1/174 (0.57%)  1
General disorders     
Asthenia  1  0/56 (0.00%)  0 2/174 (1.15%)  3
Chest discomfort  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Chills  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Discomfort  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Drug intolerance  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Facial pain  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Fatigue  1  1/56 (1.79%)  1 3/174 (1.72%)  4
Gait disturbance  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Influenza like illness  1  2/56 (3.57%)  2 3/174 (1.72%)  5
Malaise  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Non-cardiac chest pain  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Oedema peripheral  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Pain  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Peripheral swelling  1  0/56 (0.00%)  0 3/174 (1.72%)  4
Pyrexia  1  2/56 (3.57%)  3 2/174 (1.15%)  2
Hepatobiliary disorders     
Hepatic function abnormal  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Hepatic steatosis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Hepatitis  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Immune system disorders     
Seasonal allergy  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Infections and infestations     
Abscess limb  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Bacterial vaginosis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Bacteriuria  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Beta haemolytic streptococcal infection  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Breast abscess  1  1/56 (1.79%)  1 1/174 (0.57%)  1
Bronchitis  1  2/56 (3.57%)  2 3/174 (1.72%)  3
Conjunctivitis  1  1/56 (1.79%)  1 2/174 (1.15%)  2
Conjunctivitis viral  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Cystitis  1  0/56 (0.00%)  0 5/174 (2.87%)  5
Fungal skin infection  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Gastroenteritis viral  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Gastrointestinal infection  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Gingivitis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Herpes zoster  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Hordeolum  1  0/56 (0.00%)  0 3/174 (1.72%)  3
Influenza  1  2/56 (3.57%)  2 4/174 (2.30%)  4
Laryngitis  1  1/56 (1.79%)  1 1/174 (0.57%)  1
Muscle abscess  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Nasopharyngitis  1  6/56 (10.71%)  6 13/174 (7.47%)  17
Onychomycosis  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Oral herpes  1  3/56 (5.36%)  3 1/174 (0.57%)  1
Otitis externa  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Paronychia  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Periodontitis  1  1/56 (1.79%)  1 1/174 (0.57%)  1
Pharyngitis  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Pharyngitis streptococcal  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Pyelocystitis  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Rash pustular  1  0/56 (0.00%)  0 1/174 (0.57%)  2
Respiratory tract infection  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Respiratory tract infection viral  1  0/56 (0.00%)  0 3/174 (1.72%)  3
Retinitis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Rhinitis  1  0/56 (0.00%)  0 3/174 (1.72%)  3
Salpingitis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Sinusitis  1  0/56 (0.00%)  0 3/174 (1.72%)  4
Soft tissue infection  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Tinea cruris  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Tracheitis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Upper respiratory tract infection  1  3/56 (5.36%)  3 5/174 (2.87%)  5
Urinary tract infection  1  5/56 (8.93%)  6 19/174 (10.92%)  26
Urinary tract infection staphylococcal  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Viral infection  1  1/56 (1.79%)  1 2/174 (1.15%)  4
Viral pharyngitis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Viral rhinitis  1  0/56 (0.00%)  0 1/174 (0.57%)  2
Viral upper respiratory tract infection  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Injury, poisoning and procedural complications     
Arthropod bite  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Eye contusion  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Fall  1  1/56 (1.79%)  1 8/174 (4.60%)  9
Femur fracture  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Infusion related reaction  1  6/56 (10.71%)  6 16/174 (9.20%)  22
Laceration  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Ligament injury  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Ligament sprain  1  1/56 (1.79%)  1 1/174 (0.57%)  1
Multiple injuries  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Post-traumatic pain  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Procedural anxiety  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Procedural nausea  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Road traffic accident  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Skin abrasion  1  0/56 (0.00%)  0 1/174 (0.57%)  2
Thermal burn  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  1/56 (1.79%)  1 2/174 (1.15%)  2
Aspartate aminotransferase increased  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Bacterial test positive  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Blood bilirubin increased  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Blood cholesterol increased  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Blood folate decreased  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Blood glucose fluctuation  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Blood sodium decreased  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Body temperature increased  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Crystal urine present  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Electrocardiogram t wave abnormal  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Eosinophil percentage increased  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Gamma-glutamyltransferase increased  1  1/56 (1.79%)  1 2/174 (1.15%)  2
Hepatic enzyme increased  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Liver function test increased  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Lymphocyte count decreased  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Lymphocyte count increased  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Neutrophil count increased  1  1/56 (1.79%)  1 1/174 (0.57%)  1
Nuclear magnetic resonance imaging abnormal  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Weight decreased  1  0/56 (0.00%)  0 1/174 (0.57%)  1
White blood cell count increased  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Metabolism and nutrition disorders     
Hypercholesterolaemia  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Hyperlipidaemia  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Hypertriglyceridaemia  1  1/56 (1.79%)  1 1/174 (0.57%)  5
Hypoalbuminaemia  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Hypocalcaemia  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Hypokalaemia  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/56 (3.57%)  3 17/174 (9.77%)  18
Arthritis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Back pain  1  2/56 (3.57%)  2 13/174 (7.47%)  17
Bone deformity  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Coccydynia  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Costochondritis  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Flank pain  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Groin pain  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Ligament laxity  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Limb discomfort  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Muscle spasms  1  1/56 (1.79%)  1 2/174 (1.15%)  3
Muscular weakness  1  0/56 (0.00%)  0 3/174 (1.72%)  4
Musculoskeletal chest pain  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Musculoskeletal pain  1  1/56 (1.79%)  1 3/174 (1.72%)  3
Musculoskeletal stiffness  1  1/56 (1.79%)  1 2/174 (1.15%)  3
Myalgia  1  2/56 (3.57%)  4 1/174 (0.57%)  1
Neck pain  1  1/56 (1.79%)  1 4/174 (2.30%)  6
Pain in extremity  1  4/56 (7.14%)  5 1/174 (0.57%)  1
Spinal pain  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Sympathetic posterior cervical syndrome  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Tendon pain  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign ovarian tumour  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Pituitary tumour benign  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Nervous system disorders     
Allodynia  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Balance disorder  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Cognitive disorder  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Dizziness  1  1/56 (1.79%)  1 4/174 (2.30%)  4
Dysaesthesia  1  0/56 (0.00%)  0 3/174 (1.72%)  4
Epilepsy  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Facial paralysis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Headache  1  4/56 (7.14%)  4 13/174 (7.47%)  17
Hypersomnia  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Hypertonia  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Hypoaesthesia  1  1/56 (1.79%)  2 6/174 (3.45%)  11
Hypokinesia  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Intercostal neuralgia  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Migraine  1  1/56 (1.79%)  1 2/174 (1.15%)  2
Migraine with aura  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Monoparesis  1  0/56 (0.00%)  0 1/174 (0.57%)  2
Muscle spasticity  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Myasthenia gravis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Neuromyelitis optica spectrum disorder  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Paraesthesia  1  0/56 (0.00%)  0 4/174 (2.30%)  6
Post-traumatic headache  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Sacral radiculopathy  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Seizure  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Somnolence  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Syncope  1  1/56 (1.79%)  1 1/174 (0.57%)  1
Tension headache  1  1/56 (1.79%)  1 2/174 (1.15%)  3
Tremor  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Psychiatric disorders     
Abnormal dreams  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Adjustment disorder with depressed mood  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Anxiety  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Depressed mood  1  1/56 (1.79%)  1 1/174 (0.57%)  1
Depression  1  5/56 (8.93%)  5 4/174 (2.30%)  4
Depressive symptom  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Insomnia  1  1/56 (1.79%)  1 4/174 (2.30%)  4
Restlessness  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Renal and urinary disorders     
Dysuria  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Leukocyturia  1  0/56 (0.00%)  0 2/174 (1.15%)  3
Nocturia  1  0/56 (0.00%)  0 3/174 (1.72%)  3
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Fibrocystic breast disease  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Menorrhagia  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Menstrual disorder  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Metrorrhagia  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Vaginal haemorrhage  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Atelectasis  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Chronic obstructive pulmonary disease  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Cough  1  1/56 (1.79%)  3 1/174 (0.57%)  1
Hiccups  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Oropharyngeal pain  1  1/56 (1.79%)  1 4/174 (2.30%)  4
Productive cough  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Rhinorrhoea  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Yawning  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Skin and subcutaneous tissue disorders     
Acne  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Alopecia  1  2/56 (3.57%)  2 1/174 (0.57%)  1
Blister  1  0/56 (0.00%)  0 1/174 (0.57%)  3
Dermatitis contact  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Drug eruption  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Dry skin  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Eczema  1  1/56 (1.79%)  1 1/174 (0.57%)  1
Erythema  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Hidradenitis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Hyperhidrosis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Miliaria  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Night sweats  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Onychoclasis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Pruritus  1  5/56 (8.93%)  5 1/174 (0.57%)  1
Psoriasis  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Rash  1  0/56 (0.00%)  0 4/174 (2.30%)  4
Rash maculo-papular  1  1/56 (1.79%)  1 1/174 (0.57%)  1
Skin disorder  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Skin exfoliation  1  0/56 (0.00%)  0 2/174 (1.15%)  2
Skin hyperpigmentation  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Urticaria  1  1/56 (1.79%)  1 1/174 (0.57%)  1
Surgical and medical procedures     
Tooth extraction  1  0/56 (0.00%)  0 1/174 (0.57%)  1
Vascular disorders     
Deep vein thrombosis  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Hyperaemia  1  1/56 (1.79%)  1 0/174 (0.00%)  0
Hypertension  1  2/56 (3.57%)  2 3/174 (1.72%)  5
Hypotension  1  1/56 (1.79%)  1 0/174 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Viela Bio has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it is understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multicentre publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Ratchford
Organization: Viela Bio
Phone: +1 240-920-0079
EMail: ClinicalTrials@VielaBio.com
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02200770    
Other Study ID Numbers: CD-IA-MEDI-551-1155
2014-000253-36 ( EudraCT Number )
First Submitted: July 16, 2014
First Posted: July 25, 2014
Results First Submitted: October 24, 2019
Results First Posted: December 26, 2019
Last Update Posted: August 27, 2020