Phase 3
Completed N=231
N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders
Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
Source: ClinicalTrials.gov NCT02200770 ↗
Enrolled (actual)
231
Serious AEs
22.6%
Results posted
Dec 2019
Primary outcomePrimary: Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP — NA; NA Days — p=<0.0001
◆ Published Evidence
Established
55citations · ~28 / year
Safety and efficacy of inebilizumab for the treatment of neuromyelitis optica spectrum disorder: end-of-study results from the open-label period of the N-MOmentum trial.
Summary
To compare the efficacy of inebilizumab (MEDI-551) versus placebo in reducing the risk of an neuromyelitis optica/neuromyelitis optica- spectrum disorders (NMO/NMOSD) attack in participants with NMO/NMOSD.
Linked Publications (5)
-
Safety and efficacy of inebilizumab for the treatment of neuromyelitis optica spectrum disorder: end-of-study results from the open-label period of the N-MOmentum trial.
-
Inebilizumab for treatment of neuromyelitis optica spectrum disorder in patients with prior rituximab use from the N-MOmentum Study.
-
Serum neurofilament light chain levels at attack predict post-attack disability worsening and are mitigated by inebilizumab: analysis of four potential biomarkers in neuromyelitis optica spectrum disorder.
-
Disability Outcomes in the N-MOmentum Trial of Inebilizumab in Neuromyelitis Optica Spectrum Disorder.
-
Association between B-cell depletion and attack risk in neuromyelitis optica spectrum disorder: An exploratory analysis from N-MOmentum, a double-blind, randomised, placebo-controlled, multicentre phase 2/3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP |
NA; NA | <0.0001 sig |
| SECONDARY Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP |
33.9; 14.9 | 0.0033 sig |
| SECONDARY Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the Last Visit of RCP |
1.442; 1.576 | 0.9026 |
| SECONDARY Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions During RCP |
2.3; 1.6 | 0.0034 sig |
| SECONDARY Number of NMOSD-related In-patient Hospitalizations During RCP |
1.4; 1.0 | 0.0146 sig |
| SECONDARY Annualized AC-determined NMOSD Attack Rate During Any Exposure to Inebilizumab |
0.086 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) During RCP |
41; 127; 6; 9 | — |
| SECONDARY Number of Participants With TEAEs and TESAEs During OLP |
45; 144; 19; 22 | — |
| SECONDARY Number of Participants With TEAEs and TESAEs During SFP (Open-label Population) |
3; 5; 2; 1 | — |
| SECONDARY Number of Participants With TEAEs and TESAEs During SFP (Non-OLP Population) |
2; 3; 1; 1 | — |
| SECONDARY Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During RCP |
0; 2; 1; 11; 5; 35 | — |
| SECONDARY Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During OLP |
2; 6; 1; 12; 9; 21 | — |
| SECONDARY Time to Maximum Serum Concentration (Tmax) of Inebilizumab (During RCP) |
0.07; 0.07 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of Inebilizumab (During RCP) |
97.7; 108 | — |
| SECONDARY Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab (During RCP) |
667; 967 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During RCP) |
8; 17; 0; 5; 4; 7 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During OLP) |
9; 22; 0; 5; 4; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women 18 years or older with diagnosis of NMO/NMOSD
- Confirmation of NMO/NMOSD status:
- AQP4-IgG sero-positive NMO/NMOSD with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years
- AQP4-IgG sero-negative NMO with at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
- EDSS 3 months prior to randomization
- Any concomitant disease other than NMO/NMOSD that required treatment with oral or intravenous steroids at doses over 20 mg a day for over 21 days
Data sourced from ClinicalTrials.gov (NCT02200770) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.