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Ublituximab for Acute Neuromyelitis Optica (NMO) Relapses

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ClinicalTrials.gov Identifier: NCT02276963
Recruitment Status : Completed
First Posted : October 28, 2014
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Intervention Drug: Ublituximab
Enrollment 6
Recruitment Details This was a single center, phase I open label study of ublituximab in NMOSD patients with acute relapses. Patients aged 18-65 who presented to the Johns Hopkins Hospital between January and September 2016 with new neurologic symptoms were eligible for enrollment if they demonstrated a new contrast-enhancing lesion on MRI.
Pre-assignment Details There were no pre-assignment events.
Arm/Group Title Ublituximab Plus Glucocorticoids
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Ublituximab 450 mg intravenously once on day 1, plus glucocorticoids 1000 mg intravenously daily on days 1-5

Ublituximab: Monoclonal antibody that specifically binds to the trans-membrane antigen CD20, which induces immune response that causes lysis of B cells.

Period Title: Overall Study
Started 6
Completed 3
Not Completed 3
Arm/Group Title Ublituximab Plus Glucocorticoids
Hide Arm/Group Description

Ublituximab 450 mg intravenously once on day 1, plus glucocorticoids 1000 mg intravenously daily on days 1-5

Ublituximab: Monoclonal antibody that specifically binds to the trans-membrane antigen CD20, which induces immune response that causes lysis of B cells.

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
1 patient withdrew from the study prior to exposure to drug. 5 subjects were exposed to the drug. 3 patients completed the study with monthly blood tests and 90 day follow up.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
44.4  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  80.0%
White
1
  20.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
AQP4 IgG serostatus   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
AQP4 IgG seropositive
5
 100.0%
AQP4 IgG seronegative
0
   0.0%
[1]
Measure Description: Patient with neuromyelitis optica spectrum disorder are stratified by presence of a serological antibody (IgG) to Aquaporin-4 (AQP4), seropositive and seronegative.
Duration of disease  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
12.2  (4.5)
Number of previous relapses  
Mean (Standard Deviation)
Unit of measure:  Relapses
Number Analyzed 5 participants
4.8  (1.3)
Background immunotherapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
None
2
  40.0%
Mycophenolate mofetil
2
  40.0%
Rituximab
1
  20.0%
[1]
Measure Description: Patients diagnosed with neuromyelitis optica spectrum disorder are recommended off label immunotherapy to try to prevent relapses. Although some of the patients were on such immunotherapies, they failed to prevent relapses. However, they may have an impact on the severity or recovery process.
1.Primary Outcome
Title Change in Neurological Disability - Expanded Disability Scale Score
Hide Description The Kurtzke Expanded Disability Status Scale (EDSS) was developed to measure the disability status of subjects with demyelinating disease. It allows an objective quantification of the level of functioning that could be widely and reproducibly used by researchers and health care providers. The EDSS provides a total score on a scale that ranges from 0 to 10 where 0 is normal and 10 is deceased. Increasing disability is reflected in an increasing EDSS score.
Time Frame On admission to the hospital on day 1, on discharge 5-21 days later and on follow up at 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
5 subjects had EDSS measurements at the first three time points: baseline, admission and discharge. 3 subjects had EDSS scores with an additional EDSS measurement at 90-day follow up.
Arm/Group Title Ublituximab Plus Glucocorticoids
Hide Arm/Group Description:

Ublituximab 450 mg intravenously once on day 1, plus glucocorticoids 1000 mg intravenously daily on days 1-5

Ublituximab: Monoclonal antibody that specifically binds to the trans-membrane antigen CD20, which induces immune response that causes lysis of B cells.

Overall Number of Participants Analyzed 5
Median (Inter-Quartile Range)
Unit of Measure: EDSS unit score
Baseline Number Analyzed 5 participants
4.0
(2.25 to 5.5)
Admission Number Analyzed 5 participants
6.5
(5.25 to 7.5)
Discharge Number Analyzed 5 participants
6.5
(4.75 to 7.5)
90-day follow up Number Analyzed 3 participants
4.0
(2.0 to 8.0)
Time Frame 90 days
Adverse Event Reporting Description Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant’s participation in the research, whether or not considered related to the participant’s participation in the research.
 
Arm/Group Title Ublituximab Plus Glucocorticoids
Hide Arm/Group Description

Ublituximab 450 mg intravenously once on day 1, plus glucocorticoids 1000 mg intravenously daily on days 1-5

Ublituximab: Monoclonal antibody that specifically binds to the trans-membrane antigen CD20, which induces immune response that causes lysis of B cells.

All-Cause Mortality
Ublituximab Plus Glucocorticoids
Affected / at Risk (%)
Total   0/5 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ublituximab Plus Glucocorticoids
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ublituximab Plus Glucocorticoids
Affected / at Risk (%) # Events
Total   3/5 (60.00%)    
Blood and lymphatic system disorders   
Leukopenia *  1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders   
Headache/body ache *  3/5 (60.00%)  3
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Levy
Organization: Johns Hopkins University
Phone: 443-287-4412
EMail: mlevy@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02276963     History of Changes
Other Study ID Numbers: IRB00052958
First Submitted: October 21, 2014
First Posted: October 28, 2014
Results First Submitted: February 22, 2019
Results First Posted: June 6, 2019
Last Update Posted: June 6, 2019