A Study of the Effect of BIIB023 on Muscle Atrophy in Healthy Male Volunteers

August 29, 2014 updated by: Biogen

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effect of Intravenous BIIB023 (Anti-TWEAK) on Lower Limb Muscle Mass and Strength During and After Knee-Joint Immobilization in Healthy Male Volunteers

The primary objective of this study is to determine whether muscle atrophy induced by immobilization of the lower limb can be attenuated by BIIB023 in healthy male volunteers. The secondary objectives of this study in this study population are:

  • To determine whether muscle weakness induced by immobilization of the lower limb can be attenuated by BIIB023
  • To assess the effect of BIIB023 on the recovery of muscle mass and strength after immobilization
  • To assess the effect of BIIB023 on histological markers of muscle atrophy and regeneration
  • To assess the effect of BIIB023 on muscle bioenergetics based on oxidative metabolism recovery kinetics
  • To evaluate the safety and tolerability of BIIB023

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Indiana
      • Evansville, Indiana, United States
        • Research 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Key Inclusion Criteria:

  • Deemed healthy as determined by the Investigator based on medical history, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters at Screening, and physical examination at Baseline
  • Body mass index (BMI) between 18.5 and 32 kg/m2, inclusive, at the time of Screening
  • Willing to abstain from using tobacco and tobacco-containing products during the study
  • Willing to limit the intake of alcohol to no more than 2 units per day throughout the study; exceptions are 48 hours prior to Screening, 48 hours prior to Day 1, and during the in-clinic immobilization period when no alcohol will be permitted. One unit of alcohol is defined as 12 fluid ounce (fl oz) of beer, 5 fl oz of wine, or 1.5 fl oz of liquor
  • Willing to maintain a regular diet for the duration of the study and a recreational level of physical activity defined as participation in an exercise program or other physical activity at a level of intensity that does not exceed the level prior to study entry
  • Practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after the last dose of study treatment.

Key Exclusion Criteria:

  • History of or positive test result at Screening for human immunodeficiency virus (HIV).
  • History or positive test result at Screening for hepatitis C virus (HCV) antibody or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
  • History of tuberculosis (TB) or a positive QuantiFERON®-TB Gold test. There must be no other clinical evidence of TB on physical examination of the subject.
  • Use of tobacco or tobacco-containing products within 3 months prior to Screening
  • Known history of thrombophilia, hypercoagulopathy, or prior history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
  • History of physical activity consistent with endurance training or resistance training within 6 months prior to Screening
  • Any back, leg, knee, or shoulder complaints that may interfere with the use of crutches
  • Prolonged travel (more than 6 hours) within 2 weeks prior to randomization.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BIIB023
Participants receive intravenous (IV) infusions of BIIB023
Biological: BIIB023
Intravenous (IV) infusions
Other Names:
  • (anti-TWEAK [TNF-related Weak Inducer of Apoptosis] monoclonal antibody)
Placebo Comparator: Placebo
Participants receive intravenous (IV) infusions of placebo
Biological: Placebo
Matched placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage change in the magnitude of muscle atrophy
Time Frame: between Day 14 and Day 42
between Day 14 and Day 42

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage change in the magnitude of muscle atrophy, measured by T1W-MRI analysis of the CSA of the triceps surae muscles of the immobilized limb
Time Frame: between Day 14 and Day 42
between Day 14 and Day 42
Percentage change in isometric knee-extension strength (torque), measured by dynamometry
Time Frame: between Day 14 and Day 42
between Day 14 and Day 42
Percentage change in isometric plantar-flexion strength (torque), measured by dynamometry
Time Frame: between Day 14 and Day 42
between Day 14 and Day 42
Percentage change in total CSA of Type I and II fibers, measured by histological analysis of muscle biopsy
Time Frame: between Day 14, Day 21, and Day 42
between Day 14, Day 21, and Day 42
Change in density of satellite cells and other molecular markers of muscle regeneration, measured by histological analysis of muscle biopsy
Time Frame: between Day 14, Day 21, and Day 42
between Day 14, Day 21, and Day 42
Change in the recovery of muscle oxidative metabolism, measured by near-infrared spectroscopy (NIRS) of the quadriceps femoris muscles
Time Frame: between Day 14 and Day 42
between Day 14 and Day 42
The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 156
Day 156

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 211HV103

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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