Phase 3 N=231 Randomized Quadruple-blind Treatment

N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders

Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Bottom Line

View on ClinicalTrials.gov: NCT02200770 ↗

Enrolled (actual)

231

Serious AEs

22.6%

Results posted

Dec 2019

Primary outcome: Primary: Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP — NA; NA Days — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Inebilizumab (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: MedImmune LLC
Primary completion: Oct 2018

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02200770). 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.