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Trial record 13 of 140 for:    "idiopathic inflammatory myopathy"

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

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ClinicalTrials.gov Identifier: NCT02573467
Recruitment Status : Completed
First Posted : October 9, 2015
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Sporadic Inclusion Body Myositis
Interventions: Drug: Bimagrumab
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants entered extension study treatment period after completing the core study and continued on the study drug to which they were randomized in the core study (one of 3 bimagrumab doses (1mg/kg, 3mg/kg or 10mg/kg) or placebo). Participants discontinued from the treatment period were to enter a 6-month, treatment-free Follow-up Period (FUP).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants (N=211) were discontinued from the double-blind treatment period, 178 of whom entered the FUP. Overall 154 participants completed the FUP and 20 discontinued due to subject/guardian decision and 1 for technical reasons. Three discontinued FUP due to death (one each in the 10mg/kg, 3mg/kg, and placebo groups).

Reporting Groups
  Description
BYM338/Bimagrumab 10 mg/kg Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
BYM338/Bimagrumab 3 mg/kg Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
BYM338/Bimagrumab 1 mg/kg Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Placebo Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.

Participant Flow for 2 periods

Period 1:   Double-blind Treatment Epoch
    BYM338/Bimagrumab 10 mg/kg   BYM338/Bimagrumab 3 mg/kg   BYM338/Bimagrumab 1 mg/kg   Placebo
STARTED [1]   53   52   51   55 
Full Analysis Set   53   52   51   55 
COMPLETED   0   0   0   0 
NOT COMPLETED   53   52   51   55 
Lack of Efficacy                0                0                1                0 
Adverse Event                1                0                1                0 
Withdrawal by Subject                2                1                1                0 
Study Terminated by sponsor                50                51                48                55 
[1] Mean duration of exposure during the extension double-blind treatment period was 197.2 to 212.3 days

Period 2:   Post-treatment Follow up Epoch
    BYM338/Bimagrumab 10 mg/kg   BYM338/Bimagrumab 3 mg/kg   BYM338/Bimagrumab 1 mg/kg   Placebo
STARTED   41   46   44   47 
COMPLETED   35   41   34   44 
NOT COMPLETED   6   5   10   3 
Death                1                1                0                1 
Withdrawal by Subject                5                4                9                2 
Technical problems                0                0                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BYM338/Bimagrumab 10 mg/kg Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
BYM338/Bimagrumab 3 mg/kg Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period..
BYM338/Bimagrumab 1 mg/kg Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Placebo Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period.
Total Total of all reporting groups

Baseline Measures
   BYM338/Bimagrumab 10 mg/kg   BYM338/Bimagrumab 3 mg/kg   BYM338/Bimagrumab 1 mg/kg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   52   51   55   211 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.2  (8.19)   67.3  (9.04)   70.0  (7.69)   69.9  (7.95)   69.1  (8.24) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      18  34.0%      19  36.5%      17  33.3%      19  34.5%      73  34.6% 
Male      35  66.0%      33  63.5%      34  66.7%      36  65.5%      138  65.4% 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.   [ Time Frame: to end of study (up to 14 months, including the 6-month treatment-free follow-up period) ]

2.  Primary:   Change From Core Study Baseline in 6 Minute Walking Distance Test (6MWD)   [ Time Frame: Core study baseline, weeks 52, 78, 104, and >=117 ]

3.  Secondary:   Change From Core Study Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side   [ Time Frame: Core study baseline, week 52, week 78, week 104 and >=week 117 ]

4.  Secondary:   Change From Core Study Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score   [ Time Frame: Core study baseline, week 52, week 78, week 104, and >=week 117 ]

5.  Secondary:   Estimated Annual Number of Falls Per Participant Within Treatment Group   [ Time Frame: Core baseline to end of extension double-blind treatment (up to a maximum of 32 months) ]

6.  Secondary:   Change From Core Study Baseline in Short Physical Performance Battery (SPPB) Score   [ Time Frame: Core study baseline, week 52, week 78, week 104 and >=week 117 ]

7.  Secondary:   Change in Muscles of the Thigh   [ Time Frame: up to 1 year, up to 2 years ]

8.  Secondary:   Number of Patients With Anti-BYM338 Antibodies   [ Time Frame: end of double-blind treatment (up to 8 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02573467     History of Changes
Other Study ID Numbers: CBYM338B2203E1
2015-001411-12 ( EudraCT Number )
First Submitted: July 9, 2015
First Posted: October 9, 2015
Results First Submitted: February 12, 2018
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018