Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects

July 20, 2017 updated by: Novo Nordisk A/S

A Multi-centre, Randomised, Placebo Controlled, Double Blinded, Multiple Dose Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects (Explorer™3)

This trial is conducted globally. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of concizumab administered subcutaneously to haemophilia A subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Novo Nordisk Investigational Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Novo Nordisk Investigational Site
  • Austria
      • Wien, Austria, 1090
        • Novo Nordisk Investigational Site
  • Croatia
      • Zagreb, Croatia, 10 000
        • Novo Nordisk Investigational Site
  • France
      • Bron Cedex, France, 69677
        • Novo Nordisk Investigational Site
      • Nantes Cedex 1, France, 44093
        • Novo Nordisk Investigational Site
      • Rennes, France, 35033
        • Novo Nordisk Investigational Site
  • Germany
      • Berlin, Germany, 10249
        • Novo Nordisk Investigational Site
      • Duisburg, Germany, 47051
        • Novo Nordisk Investigational Site
      • Homburg, Germany, 66421
        • Novo Nordisk Investigational Site
  • Israel
      • Tel-Hashomer, Israel, 52621
        • Novo Nordisk Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Novo Nordisk Investigational Site
      • Kuching, Malaysia, 93586
        • Novo Nordisk Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Novo Nordisk Investigational Site
      • Nijmegen, Netherlands, 6525 GA
        • Novo Nordisk Investigational Site
      • Utrecht, Netherlands, 3584 CX
        • Novo Nordisk Investigational Site
  • Poland
      • Warszawa, Poland, 02-776
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Novo Nordisk Investigational Site
  • Turkey
      • Bornova-IZMIR, Turkey, 35100
        • Novo Nordisk Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • Novo Nordisk Investigational Site
      • Lviv, Ukraine, 79044
        • Novo Nordisk Investigational Site
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Novo Nordisk Investigational Site
      • London, United Kingdom, SW17 0QT
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S10 2JF
        • Novo Nordisk Investigational Site
      • Southampton, United Kingdom, SO16 6YD
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Torrance, California, United States, 90502-2004
        • Novo Nordisk Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Novo Nordisk Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Novo Nordisk Investigational Site
    • New York
      • New York, New York, United States, 10065
        • Novo Nordisk Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male subjects diagnosed with haemophilia A without inhibitors present at screening and currently treated on-demand
  • Subjects with a baseline level of factor VIII below or equal to 2 % based on medical records
  • Age between 18 and 64 years both inclusive, at the time of signing informed consent
  • Body weight between 50 and 100 kg, both inclusive

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product or related products
  • Platelet count below 50x10^9/L at screening
  • Any clinical signs or known history of thromboembolic events, or subjects considered at high risk of thromboembolic events as judged by the investigator
  • Subjects at increased risk of cardiovascular disease as judged by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
Administered subcutaneously (s.c., under the skin)
Experimental: Concizumab
Drug: Concizumab
Administered subcutaneously (s.c., under the skin) at five different dose levels (ranging from 0.25 to 1.5 mg/kg)
Drug: placebo
Administered subcutaneously (s.c., under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events (AEs)
Time Frame: From first trial drug administration (day 1) to 11 weeks after the first trial product administration
From first trial drug administration (day 1) to 11 weeks after the first trial product administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Trough level of concizumab
Time Frame: Prior to the last s.c. dose administration (day 42)
Prior to the last s.c. dose administration (day 42)
Frequency of binding non-neutralizing anti-concizumab antibodies
Time Frame: From first trial drug administration (day 1) to 11 weeks after the first trial product administration
From first trial drug administration (day 1) to 11 weeks after the first trial product administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2015

Primary Completion (Actual)

October 14, 2016

Study Completion (Actual)

October 14, 2016

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 7, 2015

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 20, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7415-4159
  • 2014-003793-16 (EudraCT Number)
  • U1111-1161-1501 (Other Identifier: WHO)
  • NL53826.018.15 (Registry Identifier: Netherlands Registry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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