Clinical trial NCT06700343: Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)
Official title: A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety Between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects With Relapsing-remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Relapsing-remitting Multiple Sclerosis (RRMS)
Keywords: Neuroscience
Neurology
Neuroimmunology
Immunosuppressants
Ocrelizumab
ABP 692
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objectives of the study are to demonstrate pharmacokinetics (PK) similarity between ABP 692 and Ocrelizumab (US), and ABP 692 and Ocrelizumab (EU), and to demonstrate pharmacodynamics (PD) similarity between ABP 692 and Ocrelizumab reference product (RP) based on assessment of the suppression of new active brain lesions over 24 weeks as assessed by magnetic brain imaging (MRI).


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017 (Thompson et al, 2018).
2. Expanded Disability Status Scale score at screening ≥ 0 and ≤ 5.5 inclusive.
3. Evidence of recent MS activity as defined by the study protocol.
4. Neurologically stable subject, with no relapse for ≤ 28 days before randomization.

Exclusion Criteria:

1. Diagnosis of primary progressive or with secondary progressive MS (Thompson et al, 2018).
2. Multiple sclerosis disease duration of ≥ 10 years in Participants with Expanded Disability Status Scale (EDSS) score of ≤ 2.5 at screening.
3. Any contraindications to study procedures or medications as outlined in the study protocol.
4. Any prohibited medication as defined in the study protocol.
5. Any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study.
6. Current or history of any significant medical conditions as described in the study protocol.
7. Any abnormal laboratory blood values as defined in the study protocol.

Primary outcomes:
measure: Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day 15 (AUC0-d15) Following Infusion 1 of the Initial Dose of Investigational Product (IP)
timeFrame: Day 1 to Day 15
measure: AUC From Time 0 Extrapolated to Infinity (AUC0-inf) of the Entire Initial Dose of IP
timeFrame: Day 1 to Day 15
measure: Total Number of New Gadolinium Enhanced (GdE) T1-weighted Lesions per Brain MRI
timeFrame: Up to Week 24
Secondary outcomes:
measure: Maximum Concentration (Cmax) Following Infusion 1 of the Initial Dose of IP at Day 1 (Cmax, d1)
timeFrame: Day 1
measure: Cmax Following Infusion 2 of the Initial Dose of IP at Day 15 (Cmax, d15)
timeFrame: Day 15
measure: AUC of the Initial Dose From Time 0 to Week 16 (AUC0-wk16) of IP
timeFrame: Up to Week 16
measure: AUC of Infusion 2 of IP From Day 15 to Week 16 (AUCd15-wk16)
timeFrame: Day 15 to Week 16
measure: Time at Which Cmax, d1 (Tmax, d1) of IP is Observed
timeFrame: Day 1
measure: Time at Which Cmax, d15 (Tmax, d15) of IP is Observed
timeFrame: Day 15
measure: Trough Concentration (Ctrough) of IP at Day 15
timeFrame: Day 15
measure: Clearance (CL) of IP
timeFrame: Up to Week 48
measure: Volume of Distribution (Vd) of IP
timeFrame: Up to week 48
measure: Terminal Elimination Half-life (T1/2) of IP
timeFrame: Up to Week 48
measure: Mean Residence Time (MRT) of IP
timeFrame: Up to Week 48
measure: Total Number of New or Enlarging T2 Hyperintense Lesions per Brain MRI
timeFrame: Up to Week 24
measure: Total Number of New or Enlarging T2 Hyperintense Lesions per Brain MRI at Week 48
timeFrame: Week 48
measure: Total Number of GdE T1-weighted Lesions per Brain MRI
timeFrame: Up to Week 24
measure: Total Number of GdE T1-weighted Lesions per Brain MRI at Week 48
timeFrame: Week 48
measure: Total Number of Combined Unique Active (CUA) Lesions per Brain MRI
timeFrame: Up to Week 24
measure: Total Number of CUA Lesions per Brain MRI at Week 48
timeFrame: Week 48
measure: Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 48
timeFrame: Week 48
measure: Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 48
timeFrame: Week 48
measure: Percentage of Participants who are Relapse-free at Week 24
timeFrame: Week 24
measure: Percentage of Participants who are Relapse-free at Week 48
timeFrame: Week 48
measure: Percentage of Participants with Anti-drug Antibodies (ADAs)
timeFrame: Up to Week 48
measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Week 96
measure: Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: Up to Week 96
measure: Number of Participants Experiencing Treatment-emergent Events of Interest (EOIs)
timeFrame: Up to Week 96
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Carlsbad
country: United States
facility: Profound Research - Neurology Center of Southern California
state: California
city: Basalt
country: United States
facility: Mountain Neurological Research Center
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research, Llc
state: Colorado
city: Boca Raton
country: United States
facility: Neurology Offices of South Florida
state: Florida
city: Naples
country: United States
facility: Aqualane Clinical Research
state: Florida
city: Pensacola
country: United States
facility: Emerald Coast Neurology/Synergy Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Medical Group
state: Florida
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience
state: Hawaii
city: Farmington
country: United States
facility: Michigan Institute For Neurological Disorders (Glendale Neurological Associates) - Farmington Hills
state: Michigan
city: Albuquerque
country: United States
facility: University of NM/Mind Imaging center
state: New Mexico
city: Columbus
country: United States
facility: The Boster Center for Multiple Sclerosis
state: Ohio
city: Dayton
country: United States
facility: Neurology Diagnostics, Inc.
state: Ohio
city: Greenville
country: United States
facility: Premier Neurology, PC
state: South Carolina
city: Knoxville
country: United States
facility: Hope Neurology
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center (VUMC)
state: Tennessee
city: Milwaukee
country: United States
facility: Medical College of Wisconsin - Froedtert Health System
state: Wisconsin
city: Ottawa
country: Canada
facility: The Ottawa Hospital Research Institute
state: Ontario
city: Tbilisi
country: Georgia
facility: LTD Pineo Medical Ecosystem
city: Tbilisi
country: Georgia
facility: Jo Ann Medical Center
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara
city: Kragujevac
country: Serbia
facility: University Clinical Centre of Kragujevac
city: Nis
country: Serbia
facility: Clinic of Neurology, University Clinical Center Nis
city: Bern
country: Switzerland
facility: Universitaetsspital Bern - Inselspital
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano, Sede Civico
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: