Clinical trial
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)
Name
ALXN1210-NMO-307
Description
The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.
Trial arms
Trial start
2019-12-13
Estimated PCD
2022-03-15
Trial end
2024-07-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Ravulizumab
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.
Arms:
Ravulizumab
Other names:
ALXN1210, Ultomiris
Size
58
Primary endpoint
Number of Participants With an Adjudicated On-trial Relapse in the Primary Treatment Period
Baseline up to 2.25 years (end of the Primary Treatment Period)
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'External Placebo-Controlled, Open-Label Design', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 58, 'type': 'ACTUAL'}}
Updated at
2023-08-09
1 organization
1 product
2 indications
Product
RavulizumabIndication
Neuromyelitis OpticaIndication
Neuromyelitis Optica Spectrum DisorderOrganization
Alexion Pharmaceuticals