Phase 2
Completed N=284
A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients
Source: ClinicalTrials.gov NCT03560739 ↗Enrolled (actual)
284
Serious AEs
2.1%
Results posted
Oct 2020
Primary outcomePrimary: Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by AUCtau — 487.7; 474.1 h×µg/mL
Summary
The primary purpose of this study is to demonstrate pharmacokinetic bioequivalence of ofatumumab injected by Pre-filled Syringe (PFS) versus Auto-Injector (AI) devices and thereby establish a bridge between the ongoing Phase 3 program and the to-be-marketed drug-device combinations
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by AUCtau |
487.7; 474.1 | — |
| PRIMARY Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by Cmax |
1.409; 1.409 | — |
| SECONDARY Pharmacokinetics of the Study Drug as Measured by AUCtau for PFS and AI Devices When Administered to Abdomen or Thigh |
487.7; 474.1; 476.0; 544.1 | — |
| SECONDARY Pharmacokinetics of the Study Drug as Measured by Cmax for PFS and AI Devices When Administered to Abdomen or Thigh |
1.409; 1.409; 1.563; 1.635 | — |
| SECONDARY Plasma Concentrations of the Study Drug for PFS and AI Devices When Administered to Abdomen or Thigh |
0.43076; 0.40075; 0.86747; 0.55704; 0.33544; 0.30511 | — |
| SECONDARY Percentage of Patients With Anti-ofatumumab Antibodies |
0.8; 3.1; 0.0; 7.7; 0.8; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of multiple sclerosis (MS)
- Relapsing MS: relapsing-remitting course (RRMS), or Secondary progressive (SPMS) course
- EDSS score of 0 to 5.5
- Documentation of at least: 1 relapse during the previous year OR 2 relapses during the previous 2 years prior to Screening OR a positive Gd-enhancing MRI scan during the year prior to randomization.
- Neurologically stable within 1 month prior to randomization
Exclusion Criteria
- Patients with primary progressive MS or SPMS without disease activity
- Disease duration of more than 10 years in patients with EDSS score of 2 or less
- Patients with an active chronic disease of the immune system other than MS
- Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to test positive for HIV antibody at Screening
- Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
Data sourced from ClinicalTrials.gov (NCT03560739). 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. Informational only — not medical advice.