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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 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.

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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

Conditions Studied

Multiple Sclerosis

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

FieldValue
Enrollment Target 284 participants
Start Date 2018-09-11
Est. Completion 2020-05-05
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03560739

The ClinicalTrials.gov registry entry for NCT03560739 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 284 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (51% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.