An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203

PHASE3CompletedINTERVENTIONAL
Enrollment

211

Participants

Timeline

Start Date

November 2, 2015

Primary Completion Date

August 17, 2016

Study Completion Date

February 13, 2017

Conditions
Sporadic Inclusion Body Myositis
Interventions
DRUG

Bimagrumab

BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.

DRUG

Placebo

Matching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.

Trial Locations (38)

1200

Novartis Investigative Site, Brussels

2065

Novartis Investigative Site, St Leonards

2100

Novartis Investigative Site, Copenhagen

2650

Novartis Investigative Site, Edegem

3162

Novartis Investigative Site, Cauldfield

6009

Novartis Investigative Site, Nedlands

8091

Novartis Investigative Site, Zurich

9000

Novartis Investigative Site, Ghent

20133

Novartis Investigative Site, Milan

21287

Novartis Investigative Site, Baltimore

25123

Novartis Investigative Site, Brescia

33101

Novartis Investigative Site, Miami

35128

Novartis Investigative Site, Padua

43221

Novartis Investigative Site, Columbus

66160

Novartis Investigative Site, Kansas City

75013

Novartis Investigative Site, Paris

75235

Novartis Investigative Site, Dallas

77030

Novartis Investigative Site, Houston

85028

Novartis Investigative Site, Phoenix

92868

Novartis Investigative Site, Orange

95817

Novartis Investigative Site, Sacramento

97239

Novartis Investigative Site, Portland

98125

Novartis Investigative Site, Messina

02114

Novartis Investigative Site, Boston

02115

Novartis Investigative Site, Boston

00168

Novartis Investigative Site, Rome

466-8560

Novartis Investigative Site, Nagoya

860-8556

Novartis Investigative Site, Kumamoto

980-8574

Novartis Investigative Site, Sendai

534-0021

Novartis Investigative Site, Osaka

187-8551

Novartis Investigative Site, Kodaira

641-8510

Novartis Investigative Site, Wakayama

770-8503

Novartis Investigative Site, Tokushima

1105 AZ

Novartis Investigative Site, Amsterdam

2333 ZA

Novartis Investigative Site, Leiden

M6 8HD

Novartis Investigative Site, Salford

NW1 2BU

Novartis Investigative Site, London

NE4 5PL

Novartis Investigative Site, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY