Author Of 2 Presentations
P0178 - Use of wearable biosensors to collect real-world patient activity data in two randomized phase 2 studies of elezanumab in multiple sclerosis (ID 987)
Abstract
Background
Clinical trials in acute and chronic neurologic conditions traditionally rely on functional assessments using clinical scales that can be insensitive to treatment response and capture a patient’s function at a single timepoint in a clinical setting. In order to assess the relative sensitivity of real-world activity levels for detection of disease progression and/or treatment response compared with in-clinic assessments, we are using wearable digital biosensors to passively collect activity data in 2 multiple sclerosis (MS) clinical trials.
Objectives
To assess patient biosensor compliance and the potential of real-world digital biosensor data to assess MS disease progression and/or treatment response
Methods
Two randomized, double-blind, placebo-controlled, 52-week Phase 2 clinical trials are currently evaluating the efficacy and safety of elezanumab in subjects with relapsing (RADIUS-R, NCT03737851) or progressive (RADIUS-P, NCT03737812) forms of MS. The primary efficacy assessment is performed in-clinic every 12 weeks. To generate real-world activity data, subjects wore MC10’s BioStamp nPoint® biosensors over 7-day intervals at Baseline and Weeks 24, 36, and 52. The sensors (chest, thigh and calf locations) monitor gait speed, step count and overall activity, including vital signs. Study sites were trained to apply, charge and reapply biosensors by MC10, and site staff trained subjects. Compliance was measured by the percentage of sensor wear days out of the instructed wear days.
Results
As of April 9, 2020, RADIUS-R had enrolled 208 subjects, RADIUS-P had enrolled 123 and 119,00 hours of actigraphy data were collected. Interim compliance rates for subjects completing each interval in RADIUS-R and RADIUS-P respectively were: Baseline (n=188, 101%; n=88, 94%), Week 24 (n=84, 99%; n=21, 86%), Week 36 (n=28, 104%; n=5, 103%), Week 52 (n=4, 79%; n=1, 114%). The average compliance rate across the studies and timepoints was 98%. All treatment-blinded actigraphy data were uploaded to the MC10 cloud for review. The objective at the completion of the studies is to determine differences between treatment groups in relation to clinical endpoints.
Conclusions
To our knowledge, these are the first randomized MS clinical trials to incorporate BioStamp biosensors to capture real-world activity. There was a high level of compliance to-date across study sites for the subjects that have completed one or more 7-day intervals, suggesting use is not overly burdensome.
P0210 - Elezanumab in patients with different disease courses of multiple sclerosis: study design and baseline analysis from two phase 2 studies (ID 404)
Abstract
Background
Background: Multiple sclerosis (MS) treatment involves disease-modifying therapies (DMTs) and symptom management. There is an unmet need for MS treatments that reverse demyelination and neuronal damage. Elezanumab (formerly ABT-555) is a monoclonal antibody that neutralizes repulsive guidance molecule A (RGMa), a neurite outgrowth inhibitor thought to be involved in MS.
Objectives
Objective: Present the study design and baseline data from 2 studies investigating elezanumab efficacy and safety in patients with progressive MS (PMS) and relapsing MS (RMS).
Methods
Methods: RADIUS-R (NCT03737851) and RADIUS-P (NCT03737812) are 2 ongoing, 52-week, proof-of-concept, RAndomized, Double-blind, placebo-controlled, multIple-dose phase 2 stUdies investigating efficacy and safety of elezanumab added to Standard of care in patients with RMS and PMS, respectively. RADIUS-R includes patients with relapsing-remitting MS (RRMS; no relapse 6 months before screening), or active secondary-progressive MS (SPMS; relapse 6 to 24 months before screening). RADIUS-P includes patients with primary-progressive MS (PPMS) or non-active SPMS (no relapses 24 months before screening). Patients in both studies were randomized 1:1:1 to receive 1 of 2 doses of elezanumab or placebo intravenously every 4 weeks through week 48. The primary endpoint for both studies is mean overall response score (ORS; based on Expanded Disability Status Scale [EDSS], Timed 25-Foot Walk [T25FW], and 9-hole Peg Test [9HPT]-dominant and nondominant) at week 52.
Results
Results: Overall, 208 patients enrolled in RADIUS-R and 123 in RADIUS-P. In RADIUS-R, 199 (96%) patients were diagnosed with RRMS, while 9 (4%) were diagnosed with SPMS. In RADIUS-P, 59 (48%) patients were diagnosed with PPMS, and 63 (52%) were diagnosed with SPMS. Baseline mean (SD) age was 45.7 (8.4) years (RADIUS-R) and 52.6 (7.0) years (RADIUS-P). Overall, 66% of RADIUS-R and 48% of RADIUS-P patients were women. Mean (SD) ORS components for RADIUS-R were: T25FW, 7.3 (4.0); 9HPT-dominant, 28.0 (22.5); and 9HPT-nondominant, 30.0 (23.5); EDSS (median [range]), 3.5 (1.0, 6.5). ORS components for RADIUS-P were: T25FW, 12.5 (11.2); 9HPT-dominant, 31.4 (27.6); and 9HPT-nondominant, 38.1 (37.3); EDSS, 6.0 (2.0, 7.0). Most patients used concomitant DMTs (RADIUS-R, 75%; RADIUS-P, 69%), most commonly ocrelizumab (RADIUS-R, 45%; RADIUS-P, 59%).
Conclusions
Conclusion: RADIUS-R and RADIUS-P are ongoing phase 2 studies investigating safety and efficacy of elezanumab as a remyelination agent.