A 12 Week Randomized Open Label Parallel Group Multicenter Study to Ev
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
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- ofatumumab with PRF
- ofatumumab with AI
- Ofatumumab
B-lymphocyte antigen CD20 binding agent
Compared with
- Ofatumumab
B-lymphocyte antigen CD20 binding agent
Results by group
Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by AUCtau
Week 8 to Week 12 dosing interval
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| OMB 20mg AI Abdomen | 487.7 h×µg/mL | 103.5 (Geometric Coefficient of Variation) | 128 |
| OMB 20mg PFS Abdomen | 474.1 h×µg/mL | 79.7 (Geometric Coefficient of Variation) | 128 |
OMB 20mg AI Abdomen
OMB 20mg PFS Abdomen
Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by Cmax
Week 8 to Week 12 dosing interval
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| OMB 20mg AI Abdomen | 1.409 µg/mL | 89.2 (Geometric Coefficient of Variation) | 128 |
| OMB 20mg PFS Abdomen | 1.409 µg/mL | 67.9 (Geometric Coefficient of Variation) | 128 |
OMB 20mg AI Abdomen
OMB 20mg PFS Abdomen
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| OMB 20mg AI (ABD) | 128 | 2 (1.6%) | 0 |
| OMB 20mg PFS Abdomen | 130 | 4 (3.1%) | 0 |
| OMB 20mg AI (THI) | 13 | 0 (0.0%) | 0 |
| OMB 20mg PFS (THI) | 13 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by AUCtau
Week 8 to Week 12 dosing interval
Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by Cmax
Week 8 to Week 12 dosing interval
How the body handles the medicineAUC and Cmax calculated from data collected in the dosing interval after Week 8 dose administration in accordance with the assessment schedule.
How the body handles the medicine
Other measures (5)
Pharmacokinetics of the Study Drug as Measured by AUCtau for PFS and AI Devices When Administered to Abdomen or Thigh
Week 8 to Week 12 dosing interval
How the body handles the medicinePharmacokinetics of the Study Drug as Measured by Cmax for PFS and AI Devices When Administered to Abdomen or Thigh
Week 8 to Week 12 dosing interval
How the body handles the medicinePlasma Concentrations of the Study Drug for PFS and AI Devices When Administered to Abdomen or Thigh
Days 4, 7, 14, 28, 42, 56, 57, 59, 63, 70, 77, 84
How the body handles the medicinePercentage of Patients With Anti-ofatumumab Antibodies
Baseline, Week 4, 8, 12 and Overall
Immune response- AUC
How the body handles the medicine
Who could take part
Relapsing and progressive · 18 to 55 · EDSS 0 to 5.5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
Papers
Results
Efficacy of the "PalliActive Caregivers" intervention for caregivers of patients with cancer in palliative care.BMC Palliat Care · 2025
Results
Effectiveness of Two Transcutaneous Electrical Nerve Stimulation (TENS) Protocols in Women with Provoked Vestibulodynia: A Randomized Controlled Trial.Med Sci (Basel) · 2023
Results
Statistical methodology for highly variable compounds: A novel design approach for the ofatumumab Phase 2 bioequivalence study.Pharm Stat · 2022
Results
Rapid and sustained B-cell depletion with subcutaneous ofatumumab in relapsing multiple sclerosis: APLIOS, a randomized phase-2 study.Mult Scler · 2022
Abdominal ofatumumab pharmacokinetic exposure was bioequivalent for autoinjector and PFS (geometric mean AUC τ , 487.7 vs 474.1 h × µg/mL (ratio 1.03); C max , 1.409 vs 1.409 µg/mL (ratio 1.00)).
Read by software from the paper's abstract
Results
Safety experience with continued exposure to ofatumumab in patients with relapsing forms of multiple sclerosis for up to 3.5 years.Mult Scler · 2022
Results
Audit and feedback with or without training in-practice targeting antibiotic prescribing (TiPTAP): a study protocol of a cluster randomised trial in dental primary care.Implement Sci · 2021
Results
Improving Cancer Patients' Insurance Choices (I Can PIC): A Randomized Trial of a Personalized Health Insurance Decision Aid.Oncologist · 2020
Results
Bio-optimized Curcuma longa extract is efficient on knee osteoarthritis pain: a double-blind multicenter randomized placebo controlled three-arm study.Arthritis Res Ther · 2019
Results
Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial.Trials · 2019
Results
Effects of inhaled hypertonic (7%) saline on lung function test in preschool children with cystic fibrosis: results of a crossover, randomized clinical trial.Ital J Pediatr · 2017
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History
Started
Sept 2018
Main results due
Aug 2019
Finished
May 2020
Results posted
Oct 2020