Relapsing-remitting Multiple Sclerosis (RRMS)
Conditions
Keywords
Neuroscience, Neurology, Neuroimmunology, Immunosuppressants, Ocrelizumab, ABP 692
Brief summary
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).
Interventions
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day15 (AUC0-d15) Following Infusion 1 ofthe Initial Dose of InvestigationalProduct (IP) | Day 1 to Day 15 |
| AUC From Time 0 Extrapolated toInfinity (AUC0-inf) of the Entire Initial Dose of IP | Day 1 to Week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Concentration (Cmax) Following Infusion 1 of the Initial Dose of IP at Day 1 (Cmax, d1) | Day 1 to Day 15 | — |
| Cmax Following Infusion 2 of theInitial Dose of IP at Day 15 (Cmax,d15) | Day 15 to Week 16 | — |
| AUC of the Initial Dose From Time 0 to Week 16 (AUC0-wk16) of IP | Day 1 to Week 16 | — |
| AUC of Infusion 2 of IP From Day 15 to Week 16 (AUCd15-wk16) | Day 15- Week 16 | — |
| Time at Which Cmax, d1 (Tmax, d1) of IP is Observed | Day 1 to Day 15 | — |
| Time at Which Cmax, d15 (Tmax, d15) of IP is Observed | Day 15 to Week 16 | — |
| Trough Concentration (Ctrough) of IP at Day 15 | Day 15 | — |
| Clearance (CL) of IP | Day 1 to Week 16 | — |
| Volume of Distribution (Vd) of IP | Day 1 to Week 16 | — |
| Terminal Elimination Half-life (T1/2) of IP | Day 1 to Week 16 | — |
| Mean Residence Time (MRT) of IP | Day 1 to Week 16 | — |
| Total number of new gadolinium enhancing (GdE) T1-weighted lesions at week 12 and week 24 | Up to Week 24 | — |
| Total number of GdE T1-weighted lesions at week 12 and week 24 | Up to Week 24 | — |
| Total Number of New or Enlarging T2 Hyperintense Lesion at Week 12 and week 24 | Up to Week 24 | — |
| Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 24 | At Week 24 | — |
| Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 24 | At Week 24 | — |
| Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 48 | At Week 48 | — |
| Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 48 | At Week 48 | — |
| Percentage of Participants who are Relapse-free at Week 24 | At Week 24 | — |
| Percentage of Participants who are Relapse-free at Week 48 | At Week 48 | — |
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Up to Week 72 | An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a treatment, combination product, medical device, or procedure. A TEAE is defined as an AE that starts or worsens on or after the first IP infusion up to the end of study visit. |
| Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAEs) | Up to Week 72 | — |
| Number of Participants Experiencing Treatment-emergent Events of Interest (EOIs) | Up to Week 72 | — |
| Percentage of Participants with Anti-drug Antibodies (ADAs) | Up to Week 48 | — |
Countries
Belgium, Bulgaria, Canada, Croatia, Czechia, Denmark, France, Georgia, Germany, Italy, Lithuania, Poland, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed