Efficacy, Safety and Tolerability of BYM338 in Patients W... | NCT01423110

Studies
Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis

NCT01423110

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Dec 17, 2020Actual

Enrollment

14Actual

Phase

Phase 2

Conditions

Sporadic Inclusion Body Myositis

Interventions

BYM338
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Aug 12, 2011

First Submission Date that Met QC Criteria

Aug 23, 2011

First Posted Date

Aug 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Aug 20, 2020

Certification/Extension First Submitted that Passed QC Review

Aug 20, 2020

Certification/Extension First Posted Date

Aug 27, 2020Actual

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 17, 2020Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BYM338	Experimental		Biological: BYM338
Placebo	Placebo Comparator		Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BYM338	Biological		BYM338
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of BYM338 on Thigh Muscle Volume by MRI	Change in thigh muscle volume	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Effect of BYM338 on muscle function by 'Timed Get Up and Go' test	Change in muscle function measured on scale by test results	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Males and Females aged 40-80 with a confirmed diagnosis of sporadic Inclusion Body Myositis

Exclusion Criteria:

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

Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Scottsdale	Arizona		United States
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25381300	Result	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.

ID	Term
D009220	Myositis
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009468	Neuromuscular Diseases