Relapsing Multiple Sclerosis
Conditions
Keywords
Relapsing Multiple Sclerosis, RMS, MS, Multiple Sclerosis
Brief summary
This study aims to examine the efficacy and safety of obexelimab in participants with relapsing multiple sclerosis
Detailed description
The study consists of a Screening Period (Day -28 to Day -1), a 24-week treatment period (Part A and Part B), a 52 week open label extension and an expected 12-week Follow-up Period. Patients with Relapsing Multiple Sclerosis will be randomized in 2:1 ratio to obexelimab or placebo. Randomization will be stratified by Gd lesion status at screening (≥ 1 vs 0). Part A is the 12-week Randomized Placebo-Controlled Period (RCP), during which obexelimab or placebo will be administered as weekly subcutaneous (SC) injections. Following Part A, all patients will enter the Part B, a 12-week Open-Label Period (OLP), during which all patients will receive obexelimab administered as weekly SC injections. After Part B, patients will enter Part C, a 52-week Open-Label Extension (OLE), after which they will return for an in-clinic Safety Follow-Up Visit 12 weeks after the completion of Part C (i.e. Week 88). If at this time, B cells have not returned to baseline or above the lower limit of normal (LLN), patients will be asked to return every 12 weeks until B cells return to baseline or above the LLN (at minimum). The maximum expected duration of the study is 92 weeks (Screening Period = 4 weeks, Parts A, B and C = 76 weeks, Follow-up Period = 12 weeks).
Interventions
DRUGObexelimab
Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRIIb, resulting in down regulation of B cell activity
DRUGPlacebo
Placebo
Sponsors
Zenas BioPharma (USA), LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, Care Providers, Investigator, Outcomes Assessor
Intervention model description
This is a Phase 2, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of obexelimab in patients with RMS. The study consists of a Screening Period (Day 28 to Day -1), followed by a 24-week Treatment Period (Part A or RCP consists of 12 doses of obexelimab or placebo; Part B or OLP consists of 12 doses of open-label obexelimab), a 52-week OLE and an expected 12-week Follow-up Period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of RMS (relapsing-remitting or secondary progressive with relapses) according to the 2017 revision of the McDonald diagnostic criteria 2. An EDSS of ≤ 5.5 at the Screening Visit 3. Must have documentation of: 1. . at least 1 relapse within the previous year OR 2. . ≥ 2 relapses within the past 2 years OR 3. . ≥ 1 active Gd-enhancing brain lesion on an MRI scan within the past 6 months prior to screening 4. Not of childbearing potential or willing to follow contraceptive guidance
Exclusion criteria
1. Primary progressive MS or secondary progressive MS without relapses 2. Meet criteria for neuromyelitis optica spectrum disorder 3. Relapse in the 30 days prior to randomization 4. ≥ 10 years disease duration from onset with patient's EDSS ≤ 2.0 (patient reported is adequate in absence of written medical record) 5. Has \> 20 Gd+ lesions on brain MRI at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative number of new GdE T1 hyperintense lesions | Week 8 and Week 12 | Cumulative number of new GdE T1 hyperintense lesions as measured by brain MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of T2 Lesions | Week 8 and Week 12 | cumulative number of new and/or enlarging T2 weighted hyperintense lesions |
| Number of GdE T1 lesions | Week 4, Week 8, and Week 12 | number of new GdE T1 hyperintense lesions |
| Volume of T2 lesions | Week 12 | change from baseline in volume of T2 lesions |
| Serum NfL | Week 12 | serum NfL |
| Incidence of Adverse Events, injection site reactions and hypersensitivity reactions | 24 weeks | Incidence of Adverse Events, injection site reactions and hypersensitivity reactions, serious adverse events, and adverse events of special interest, as defined by the CTCAE v5.0 |
Countries
Austria, Belgium, China, Croatia, Czechia, Denmark, Greece, Italy, Poland, Spain, United Kingdom, United States
Outcome results
None listed