NCT01423110

Brief Summary

This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 25, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 17, 2020

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

August 12, 2011

Last Update Submit

December 11, 2020

Conditions

Sporadic Inclusion Body Myositis

Keywords

sporadic Inclusion Body Myositis

Outcome Measures

Primary Outcomes (1)

  • Effect of BYM338 on Thigh Muscle Volume by MRI

    Change in thigh muscle volume

    8 weeks

Secondary Outcomes (1)

  • Effect of BYM338 on muscle function by 'Timed Get Up and Go' test

    8 weeks

Study Arms (2)

BYM338

EXPERIMENTAL
Biological: BYM338

Placebo

PLACEBO COMPARATOR
Biological: Placebo

Interventions

BYM338BIOLOGICAL
BYM338
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Unable to walk at least 3 meters without assistance from another person
  • Use of oral beta agonists, oral corticosteroids, androgens or androgen inhibitors, or intravenous gamma globulin in the last 6 months
  • patients with a history or presence of renal impairment and/or liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novartis Investigative Site

Scottsdale, Arizona, United States

Location

Novartis Investigative Site

Kansas City, Kansas, United States

Location

Novartis Investigative Site

Boston, Massachusetts, United States

Location

Related Publications (1)

  • Amato AA, Sivakumar K, Goyal N, David WS, Salajegheh M, Praestgaard J, Lach-Trifilieff E, Trendelenburg AU, Laurent D, Glass DJ, Roubenoff R, Tseng BS, Greenberg SA. Treatment of sporadic inclusion body myositis with bimagrumab. Neurology. 2014 Dec 9;83(24):2239-46. doi: 10.1212/WNL.0000000000001070. Epub 2014 Nov 7.

    PMID: 25381300RESULT

Related Links

MeSH Terms

Conditions

Myositis, Inclusion Body

Interventions

bimagrumab

Condition Hierarchy (Ancestors)

MyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2011

First Posted

August 25, 2011

Study Start

August 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

December 17, 2020

Record last verified: 2017-02

Locations

US(3)