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An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD

Primary Purpose

Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ravulizumab
Sponsored by
Alexion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromyelitis Optica focused on measuring Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Devic's Disease, Transverse Myelitis, Optic Neuritis, Relapse, Ravulizumab, Ultomiris, ALXN1210, CNS Autoimmune Disorders, Demyelinating Disorders, NMO, NMOSD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Anti-aquaporin-4 antibody-positive and a diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria.
  2. At least 1 attack or relapse in the last 12 months prior to the Screening Period.
  3. Expanded Disability Status Scale score ≤7.
  4. Participants who enter the study receiving supportive immunosuppressive therapy must be on a stable dosing regimen of adequate duration prior to Screening.
  5. Body weight ≥40 kilograms.
  6. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

  1. History of neisseria meningitidis infection.
  2. Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody titer).
  3. Previously or currently treated with a complement inhibitor.
  4. Use of rituximab or mitoxantrone within 3 months prior to Screening.
  5. Use of IV immunoglobulin within 3 weeks prior to Screening.

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ravulizumab

Arm Description

During the Primary Treatment Period, all participants will receive open-label ravulizumab via intravenous (IV) infusion starting on Day 1. The end of the Primary Treatment Period will be triggered when the last enrolled participant completes between 26 and 50 weeks in the study (depending on the number of adjudicated On-Trial Relapse observed). After completion of the Primary Treatment Period, all participants will have the opportunity to continue receiving ravulizumab in the Long-Term Extension Period of the study. For each participant, the Long-Term Extension Period continues for up to 2 years, or until ravulizumab is approved and/or available (in accordance with country-specific regulations), whichever occurs first.

Outcomes

Primary Outcome Measures

Number of Participants With an Adjudicated On-trial Relapse in the Primary Treatment Period
An On-trial Relapse was defined as a new onset of neurologic symptoms or worsening of existing neurologic symptoms with an objective change (clinical sign) on neurologic examination that persisted for more than 24 hours as confirmed by the treating physician. An adjudicated On-trial Relapse was defined by the protocol and positively adjudicated by the independent relapse adjudication committee.

Secondary Outcome Measures

Adjudicated On-trial Annualized Relapse Rate (ARR) in the Primary Treatment Period
The adjudicated On-trial ARR was computed as the total number of relapses divided by the total number of participant years in the study period. A central independent committee was used to adjudicate all On-trial Relapses as determined by the treating physician. Results reported as adjusted adjudicated On-trial ARR based on a Poisson regression centered on the mean historical ARR in the 24 months prior to screening.
Number of Participants With Clinically Important Change From Baseline in Hauser Ambulation Index (HAI) Score at the End of Primary Treatment Period
The HAI is a rating scale developed to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. The scale ranges from 0 to 9, with 0 being the best score (asymptomatic; fully ambulatory with no assistance) and 9 being the worst (restricted to wheelchair; unable to transfer self independently). Clinically important change is conditional on the baseline value: worsening if the baseline HAI is 0 and at least 2 points increase or if the baseline HAI is >0 and at least 1 point increase; improvement if the baseline value is at least 2 and at least 1 point decrease; and stable if baseline is 0 or 1 and a 0- or 1-point increase or decrease or baseline is at least 2 and not change.
Change From Baseline in European Quality of Life Health 5-dimension Questionnaire (EQ-5D) Index Score at the End of Primary Treatment Period
The EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. It consists of 2 parts; the EQ-5D descriptive system and the EQ-5D visual analogue scale (VAS). The EQ-5D descriptive system includes 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: "no problem" (level 1), "some problems" (level 2), "extreme problems" (level 3). The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. The 5 dimensional 3-level systems was converted into single index utility score that ranges from less than 0 to 1, with higher scores representing a better health status.
Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score at the End of Primary Treatment Period
The EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. It consists of 2 parts; the EQ-5D descriptive system and the EQ-5D visual analogue scale (VAS). The EQ-5D VAS is an overall health state scale where the participant selects a number between 0 to 100 to describe the condition of their health, with 100 being 'The best health state you can imagine' and 0 being 'The worst health state you can imagine'. An increase in score indicates improvement.
Number of Participants With Clinically Important Worsening From Baseline in Expanded Disability Status Scale (EDSS) Score at the End of Primary Treatment Period
Disease-related disability was measured by the EDSS. The EDSS is an ordinal clinical rating scale that ranges from 0 (normal neurologic examination) to 10 (death) in half-point increments. Clinically important worsening was defined as an increase in EDSS score conditional on the baseline value: If the baseline EDSS was 0 and at least 2-point increase; if the baseline is 1 to 5, and at least 1-point increase; if the baseline is > 5 and at least 0.5 increase.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs Leading to Study Drug Discontinuation in the Primary Treatment Period
An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. TEAEs were AEs with a start date on or after the date of the first dose of study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Serum Ravulizumab Concentration
Change From Baseline in Serum Free C5 Concentration at Week 26 and 50
Number of Participants With Anti-drug Antibodies (ADAs) During the Primary Treatment Period

Full Information

First Posted
December 11, 2019
Last Updated
July 17, 2023
Sponsor
Alexion
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1. Study Identification

Unique Protocol Identification Number
NCT04201262
Brief Title
An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD
Official Title
A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder
Keywords
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Devic's Disease, Transverse Myelitis, Optic Neuritis, Relapse, Ravulizumab, Ultomiris, ALXN1210, CNS Autoimmune Disorders, Demyelinating Disorders, NMO, NMOSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
External Placebo-Controlled, Open-Label Design
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ravulizumab
Arm Type
Experimental
Arm Description
During the Primary Treatment Period, all participants will receive open-label ravulizumab via intravenous (IV) infusion starting on Day 1. The end of the Primary Treatment Period will be triggered when the last enrolled participant completes between 26 and 50 weeks in the study (depending on the number of adjudicated On-Trial Relapse observed). After completion of the Primary Treatment Period, all participants will have the opportunity to continue receiving ravulizumab in the Long-Term Extension Period of the study. For each participant, the Long-Term Extension Period continues for up to 2 years, or until ravulizumab is approved and/or available (in accordance with country-specific regulations), whichever occurs first.
Intervention Type
Biological
Intervention Name(s)
Ravulizumab
Other Intervention Name(s)
ALXN1210, Ultomiris
Intervention Description
Participants will receive a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until end of the Long-Term Extension Period.
Primary Outcome Measure Information:
Title
Number of Participants With an Adjudicated On-trial Relapse in the Primary Treatment Period
Description
An On-trial Relapse was defined as a new onset of neurologic symptoms or worsening of existing neurologic symptoms with an objective change (clinical sign) on neurologic examination that persisted for more than 24 hours as confirmed by the treating physician. An adjudicated On-trial Relapse was defined by the protocol and positively adjudicated by the independent relapse adjudication committee.
Time Frame
Baseline up to 2.25 years (end of the Primary Treatment Period)
Secondary Outcome Measure Information:
Title
Adjudicated On-trial Annualized Relapse Rate (ARR) in the Primary Treatment Period
Description
The adjudicated On-trial ARR was computed as the total number of relapses divided by the total number of participant years in the study period. A central independent committee was used to adjudicate all On-trial Relapses as determined by the treating physician. Results reported as adjusted adjudicated On-trial ARR based on a Poisson regression centered on the mean historical ARR in the 24 months prior to screening.
Time Frame
Baseline up to 2.25 years (end of the Primary Treatment Period)
Title
Number of Participants With Clinically Important Change From Baseline in Hauser Ambulation Index (HAI) Score at the End of Primary Treatment Period
Description
The HAI is a rating scale developed to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. The scale ranges from 0 to 9, with 0 being the best score (asymptomatic; fully ambulatory with no assistance) and 9 being the worst (restricted to wheelchair; unable to transfer self independently). Clinically important change is conditional on the baseline value: worsening if the baseline HAI is 0 and at least 2 points increase or if the baseline HAI is >0 and at least 1 point increase; improvement if the baseline value is at least 2 and at least 1 point decrease; and stable if baseline is 0 or 1 and a 0- or 1-point increase or decrease or baseline is at least 2 and not change.
Time Frame
Baseline up to 2.25 years (end of the Primary Treatment Period)
Title
Change From Baseline in European Quality of Life Health 5-dimension Questionnaire (EQ-5D) Index Score at the End of Primary Treatment Period
Description
The EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. It consists of 2 parts; the EQ-5D descriptive system and the EQ-5D visual analogue scale (VAS). The EQ-5D descriptive system includes 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: "no problem" (level 1), "some problems" (level 2), "extreme problems" (level 3). The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. The 5 dimensional 3-level systems was converted into single index utility score that ranges from less than 0 to 1, with higher scores representing a better health status.
Time Frame
Baseline, up to 2.25 years (end of the Primary Treatment Period)
Title
Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score at the End of Primary Treatment Period
Description
The EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. It consists of 2 parts; the EQ-5D descriptive system and the EQ-5D visual analogue scale (VAS). The EQ-5D VAS is an overall health state scale where the participant selects a number between 0 to 100 to describe the condition of their health, with 100 being 'The best health state you can imagine' and 0 being 'The worst health state you can imagine'. An increase in score indicates improvement.
Time Frame
Baseline, up to 2.25 years (end of the Primary Treatment Period)
Title
Number of Participants With Clinically Important Worsening From Baseline in Expanded Disability Status Scale (EDSS) Score at the End of Primary Treatment Period
Description
Disease-related disability was measured by the EDSS. The EDSS is an ordinal clinical rating scale that ranges from 0 (normal neurologic examination) to 10 (death) in half-point increments. Clinically important worsening was defined as an increase in EDSS score conditional on the baseline value: If the baseline EDSS was 0 and at least 2-point increase; if the baseline is 1 to 5, and at least 1-point increase; if the baseline is > 5 and at least 0.5 increase.
Time Frame
Baseline up to 2.25 years (end of the Primary Treatment Period)
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs Leading to Study Drug Discontinuation in the Primary Treatment Period
Description
An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. TEAEs were AEs with a start date on or after the date of the first dose of study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time Frame
Baseline up to 2.25 years (end of the Primary Treatment Period)
Title
Serum Ravulizumab Concentration
Time Frame
Predose and end of infusion (EOI) at Week 26
Title
Change From Baseline in Serum Free C5 Concentration at Week 26 and 50
Time Frame
Baseline, Week 26 (Predose and EOI)
Title
Number of Participants With Anti-drug Antibodies (ADAs) During the Primary Treatment Period
Time Frame
Baseline, Weeks 26, 50, 82, and 106

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anti-aquaporin-4 antibody-positive and a diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria. At least 1 attack or relapse in the last 12 months prior to the Screening Period. Expanded Disability Status Scale score ≤7. Participants who enter the study receiving supportive immunosuppressive therapy must be on a stable dosing regimen of adequate duration prior to Screening. Body weight ≥40 kilograms. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: History of neisseria meningitidis infection. Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody titer). Previously or currently treated with a complement inhibitor. Use of rituximab or mitoxantrone within 3 months prior to Screening. Use of IV immunoglobulin within 3 weeks prior to Screening.
Facility Information:
Facility Name
Clinical Study Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Clinical Study Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Clinical Study Site
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
Clinical Study Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Clinical Study Site
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Clinical Study Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Clinical Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Clinical Study Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Clinical Study Site
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Clinical Study Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Clinical Study Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Clinical Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Clinical Study Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Clinical Study Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Clinical Study Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Clinical Study Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Clinical Study Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Clinical Study Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Clinical Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Clinical Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Study Site
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Clinical Study Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Clinical Study Site
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Clinical Study Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Clinical Study Site
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Clinical Study Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Clinical Study Site
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 2X6
Country
Canada
Facility Name
Clinical Study Site
City
Edmonton
ZIP/Postal Code
T6G-2G3
Country
Canada
Facility Name
Clinical Study Site
City
Aarhus
Country
Denmark
Facility Name
Clinical Study Site
City
Bron Cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Clinical Study Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Clinical Study Site
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Clinical Study Site
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Clinical Study Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Clinical Study Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Clinical Study Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Clinical Study Site
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Clinical Study Site
City
Cefalu
ZIP/Postal Code
90015
Country
Italy
Facility Name
Clinical Study Site
City
Gallarate
ZIP/Postal Code
21013
Country
Italy
Facility Name
Clinical Study Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Clinical Study Site
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Clinical Study Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Clinical Study Site
City
Roma
ZIP/Postal Code
00178
Country
Italy
Facility Name
Clinical Study Site
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Clinical Study Site
City
Fukuoka-shi
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Clinical Study Site
City
Kawagoe-shi
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Clinical Study Site
City
Niigata-shi
ZIP/Postal Code
951-8510
Country
Japan
Facility Name
Clinical Study Site
City
Sendai-shi
ZIP/Postal Code
984-0042
Country
Japan
Facility Name
Clinical Study Site
City
Sendai
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Clinical Study Site
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Clinical Study Site
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Clinical Study Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Clinical Study Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Clinical Study Site
City
Seoul
ZIP/Postal Code
05080
Country
Korea, Republic of
Facility Name
Clinical Study Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Clinical Study Site
City
Seoul
ZIP/Postal Code
135-798
Country
Korea, Republic of
Facility Name
Clinical Study Site
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
Clinical Study Site
City
Katowice
ZIP/Postal Code
40-571
Country
Poland
Facility Name
Clinical Study Site
City
Lodz
ZIP/Postal Code
90-324
Country
Poland
Facility Name
Clinical Study Site
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Clinical Study Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Clinical Study Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Clinical Study Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Clinical Study Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Clinical Study Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Clinical Study Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Clinical Study Site
City
Liverpool
ZIP/Postal Code
L9 7JL
Country
United Kingdom
Facility Name
Clinical Study Site
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD

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