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

Completed · Phase 2

Conditions studied: Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT03560739

Run by

Novartis Pharmaceuticals

People needed

284

Starts

2018-09-11

Expected to finish

2020-05-05

Last updated by the study team

2021-10-08

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Fullerton, California, United States
• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Basalt, Colorado, United States
• Novartis Investigative Site — Boulder, Colorado, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — West Palm Beach, Florida, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Ozark, Missouri, United States
• Novartis Investigative Site — Knoxville, Tennessee, United States
• Novartis Investigative Site — Round Rock, Texas, United States
• Novartis Investigative Site — Sherman, Texas, United States
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Sofia, Bulgaria
• Novartis Investigative Site — Sofia, Bulgaria
• Novartis Investigative Site — Sofia, Bulgaria
• Novartis Investigative Site — Sofia, Bulgaria
• Novartis Investigative Site — Brno, Czech Republic, Czechia
• Novartis Investigative Site — Havířov, Czech Republic, Czechia
• Novartis Investigative Site — Teplice, Czech Republic, Czechia
• Novartis Investigative Site — Hradec Králové, CZE, Czechia
• Novartis Investigative Site — Pardubice, Czechia
• Novartis Investigative Site — Tallinn, Estonia

Full record on ClinicalTrials.gov

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