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NCT03560739 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 284
- Enrollment target
- 20
- Study locations
NCT03560739: Completed Phase 2 study of Multiple Sclerosis, sponsored by Novartis Pharmaceuticals.
NCT03560739 is a Phase 2 study of Multiple Sclerosis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 284 participants, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03560739, a Phase 2 study of Multiple Sclerosis, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 284 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
Bioequivalence of AUCtau ) will be measured over the time period of Week 8 to Week 12 dosing interval comparing the pre-filled syringe (PFS) and autoinjector (AI) devices both administered to the abdomen. Bioequivalence established if both measures meet the corresponding criterion specified by the reference-scaled average bioequivalence (RSABE) approach
Conditions Studied
Interventions
- COMBINATION_PRODUCT ofatumumab with PRF
- COMBINATION_PRODUCT ofatumumab with AI
Study Locations (20)
Other
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Sofia
- Novartis Investigative Site - Sofia
- Novartis Investigative Site - Sofia
- Novartis Investigative Site - Sofia
Florida
- Novartis Investigative Site - Miami
- Novartis Investigative Site - Tampa
- Novartis Investigative Site - Tampa
- Novartis Investigative Site - West Palm Beach
Colorado
- Novartis Investigative Site - Aurora
- Novartis Investigative Site - Basalt
- Novartis Investigative Site - Boulder
Texas
- Novartis Investigative Site - Round Rock
- Novartis Investigative Site - Sherman
California
- Novartis Investigative Site - Fullerton
Indiana
- Novartis Investigative Site - Indianapolis
Missouri
- Novartis Investigative Site - Ozark
Tennessee
- Novartis Investigative Site - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 284 participants |
| Start Date | 2018-09-11 |
| Est. Completion | 2020-05-05 |
| Phase | Phase 2 |
What the finished NCT03560739 record still lists
NCT03560739 is an interventional study that assigns participants to a tested intervention. The registered 284 participants enrollment target is mid-sized for trials with a published cap, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which ofatumumab with PRF is the first listed.
NCT03560739 names 20 study sites across 9 states, led by Other, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT03560739 about?
NCT03560739 is a clinical study titled "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". 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
What is the current status of trial NCT03560739?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 284 participants. The study started on 2018-09-11. Estimated completion is 2020-05-05.
What conditions does trial NCT03560739 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT03560739?
The interventions under investigation include: ofatumumab with PRF (COMBINATION_PRODUCT), ofatumumab with AI (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03560739?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03560739 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Indiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03560739's enrollment target sits among peer trials
284 61st of 315 higher than 255 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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