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Recruitment Complete
Sponsor ID
20230309

Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

Sponsor ID
20230309
Clinicaltrials.gov ID
NCT06700343
EUCTIS ID
N/A
EudraCT ID
2024-512914-16
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Study Details

The Main objectives of the study are to demonstrate pharmacokinetic (PK) similarity between ABP 692 and ocrelizumab (US), as well as between ABP 692 and ocrelizumab (EU).

Additional Study Details

Phase
Phase 3
Product
ABP 692
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
152
Additional Study Details

Protocol Summary

Primary Outcome Measures

Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day15 (AUC0-d15) Following Infusion 1 ofthe Initial Dose of InvestigationalProduct (IP)

Timeframe: Day 1 to Day 15

AUC From Time 0 Extrapolated toInfinity (AUC0-inf) of the Entire Initial Dose of IP

Timeframe: Day 1 to Week 16

Secondary Outcome Measures

Maximum Concentration (Cmax) Following Infusion 1 of the Initial Dose of IP at Day 1 (Cmax, d1)

Timeframe: Day 1 to Day 15

Cmax Following Infusion 2 of theInitial Dose of IP at Day 15 (Cmax,d15)

Timeframe: Day 15 to Week 16

AUC of the Initial Dose From Time 0 to Week 16 (AUC0-wk16) of IP

Timeframe: Day 1 to Week 16

AUC of Infusion 2 of IP From Day 15 to Week 16 (AUCd15-wk16)

Timeframe: Day 15- Week 16

Time at Which Cmax, d1 (Tmax, d1) of IP is Observed

Timeframe: Day 1 to Day 15

Time at Which Cmax, d15 (Tmax, d15) of IP is Observed

Timeframe: Day 15 to Week 16

Trough Concentration (Ctrough) of IP at Day 15

Timeframe: Day 15

Clearance (CL) of IP

Timeframe: Day 1 to Week 16

Volume of Distribution (Vd) of IP

Timeframe: Day 1 to Week 16

Terminal Elimination Half-life (T1/2) of IP

Timeframe: Day 1 to Week 16

Mean Residence Time (MRT) of IP

Timeframe: Day 1 to Week 16

Total number of new gadolinium enhancing (GdE) T1-weighted lesions at week 12 and week 24

Timeframe: Up to Week 24

Total number of GdE T1-weighted lesions at week 12 and week 24

Timeframe: Up to Week 24

Total Number of New or Enlarging T2 Hyperintense Lesion at Week 12 and week 24

Timeframe: Up to Week 24

Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 24

Timeframe: At Week 24

Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 24

Timeframe: At Week 24

Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 48

Timeframe: At Week 48

Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 48

Timeframe: At Week 48

Percentage of Participants who are Relapse-free at Week 24

Timeframe: At Week 24

Percentage of Participants who are Relapse-free at Week 48

Timeframe: At Week 48

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to Week 72

Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAEs)

Timeframe: Up to Week 72

Number of Participants Experiencing Treatment-emergent Events of Interest (EOIs)

Timeframe: Up to Week 72

Percentage of Participants with Anti-drug Antibodies (ADAs)

Timeframe: Up to Week 48

Locations

Location
Status
Contact Us
Location
Advanced Neurosciences Research, Llc
Fort Collins, Colorado, United States, 80528
Status
Recruiting
Location
Neurology Offices of South Florida
Boca Raton, Florida, United States, 33428
Status
Recruiting
Location
Hope Neurology
Knoxville, Tennessee, United States, 37922
Status
Recruiting
Location
Premiere Research Institute Palm Beach
West Palm Beach, Florida, United States, 33407
Status
Recruiting
Location
Profound Research - Neurology Center of Southern California
Carlsbad, California, United States, 92011
Status
Recruiting
Location
Premier Neurology, PC
Greenville, South Carolina, United States, 29650
Status
Recruiting
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Study Info
Age
18 - 99 Years
Condition
  • Relapsing-Remitting Multiple Sclerosis (RRMS)
    • Sex
    All
    Trial Dates
    Jan 2025 - Apr 2027
    Inclusion and Exclusion 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.