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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 October 2021
• Main ID: NCT03560739
• Date of registration: 15/05/2018
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: 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
• Scientific title: 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
• Date of first enrolment: September 11, 2018
• Target sample size: 284
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03560739
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Austria, Bulgaria, Czechia, Estonia, Latvia, Lithuania, Russian Federation, Spain, United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Combination Product: ofatumumab with PRF

Combination Product: ofatumumab with AI

Primary Outcome(s)

Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by Cmax [Time Frame: 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 AUCtau [Time Frame: Week 8 to Week 12 dosing interval]

Secondary Outcome(s)

Plasma Concentrations of the Study Drug for PFS and AI Devices When Administered to Abdomen or Thigh [Time Frame: Days 4, 7, 14, 28, 42, 56, 57, 59, 63, 70, 77, 84]

Percentage of Patients With Anti-ofatumumab Antibodies [Time Frame: Baseline, Week 4, 8, 12 and Overall]

Pharmacokinetics of the Study Drug as Measured by Cmax for PFS and AI Devices When Administered to Abdomen or Thigh [Time Frame: Week 8 to Week 12 dosing interval]

Pharmacokinetics of the Study Drug as Measured by AUCtau for PFS and AI Devices When Administered to Abdomen or Thigh [Time Frame: Week 8 to Week 12 dosing interval]

Secondary ID(s)

COMB157G2102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03560739