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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

NCT03560739 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2021-10-08

Study results available
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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

Interventions

COMBINATION_PRODUCT

ofatumumab with PRF

ofatumumab 20 mg subcutanious injection administered with pre-filled syringe (PRF)

COMBINATION_PRODUCT

ofatumumab with AI

ofatumumab 20 mg subcutaneous injection administered with autoinjector (AI)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-11
Primary Completion
2019-08-26
Completion
2020-05-05
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Bulgaria
  • Czechia
  • Estonia
  • Latvia
  • Lithuania
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03560739 on ClinicalTrials.gov