Phase 2
N=64
Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab
Relapsing Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03249714 ↗Enrolled (actual)
64
Serious AEs
1.6%
Results posted
Feb 2022
Primary outcome: Primary: Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Core Part — 0.0670; 1.0413 lesions per scan — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ofatumumab (Drug); Matching placebo of ofatumumab (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Core Part |
0.0670; 1.0413 | <0.001 sig |
| SECONDARY Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Japan vs Non-Japan - Core Part |
0.1999; 1.4682; 0.0000; 0.6774 | 0.003 sig |
| SECONDARY Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Core Part |
3.7344; 13.1533 | 0.002 sig |
| SECONDARY Annualized Relapse Rate (ARR) - Core Part |
0.2640; 0.6286 | 0.119 |
| SECONDARY Pharmacokinetic (PK) Concentrations of Ofatumumab - Core Part |
0.03; 0.9; .06; .43; .24; 0.33 | — |
| SECONDARY B-cell Counts - Japan vs Non-Japan - Core Part |
207; 205; 208; 244; 3.0; 319.0 | — |
| SECONDARY Number of Gadolinium-enhancing T1 Lesions Per MRI Scan - Extension Part |
0.027; 0.025 | — |
| SECONDARY Number of New or Enlarging T2 Lesions on MRI Scans (Annualized T2 Lesion Rate) - Extension Part |
0.230; 0.813 | — |
| SECONDARY Annualized Relapse Rate (ARR) - Extension Part |
0.081; 0.083 | — |
| SECONDARY Pharmacokinetic (PK) Concentrations of Ofatumumab - Extension Part |
.84; .64; 0.64; .61; .97; .72 | — |
| SECONDARY B-cell Counts - Extension Part |
0.0; 1.0; 0.5; 1.0; 1.0; 4.0 | — |
| SECONDARY Participants With Confirmed Relapse - Core and Extension Parts |
3; 2; 1; 4; 1; 0 | — |
Summary
The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with relapsing multiple sclerosis (RMS) in Japan and the other countries
Eligibility Criteria
Inclusion Criteria
- Diagnosis of multiple sclerosis (MS)
- Relapsing MS (RMS)
- At least 1 appearance of a new neurological abnormality or worsening of pre-existing neurological abnormality during the previous 2 years prior to Screening AND an MRI activity (Gd-enhancing T1 lesions or new or enlarging T2 lesions) in brain during the previous 1 year prior to randomization
- EDSS score of 0 to 5.5
Exclusion Criteria
- Primary progressive MS or SPMS without disease activity
- Patients with an active chronic disease of the immune system other than MS
- Patients at risk of developing or having reactivation of hepatitis
- Patients with active systemic infections or with neurological findings consistent with PML
Data sourced from ClinicalTrials.gov (NCT03249714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.