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Trial record 1 of 1 for:    NCT02250443
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Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis (BYM338)

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ClinicalTrials.gov Identifier: NCT02250443
Recruitment Status : Completed
First Posted : September 26, 2014
Results First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Sporadic Inclusion Body Myositis (sIBM)
Intervention: Drug: BYM338 (Bimagrumab)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Due to lack of efficacy in patients with sIBM, the study was terminated early.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BYM338 BYM338 Group

Participant Flow:   Overall Study
    BYM338
STARTED   10 
COMPLETED   0 
NOT COMPLETED   10 
Administrative problems                7 
Adverse Event                3 



  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 BYM338 Group

Baseline Measures
   BYM338 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.1  (10.39) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  40.0% 
Male      6  60.0% 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: Up to 29 month ]

2.  Secondary:   Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA)   [ Time Frame: Baseline, Day 1, 57, 113, 169, 365, 533, and day 729 ]

3.  Secondary:   Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing   [ Time Frame: Day 29, 85, 169, 253, 337, 421, 505, 589, 673, 757, 1177 ]

4.  Secondary:   Changes From Baseline in Physical Function Reported by Patients   [ Time Frame: Baseline, Week 104 ]

5.  Secondary:   Changes From Baseline in Muscle Strength.   [ Time Frame: Baseline, Day 1, 113, 169, 365, 533, 729 ]

6.  Secondary:   Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)   [ Time Frame: Baseline,Day 1, 113, 169, 365, 533, 729 ]

7.  Secondary:   Changes From Baseline in Muscle Function 6 Minute Walking Distance   [ Time Frame: Baseline,Day 1, 113, 169, 365, 533, 729 ]

8.  Secondary:   Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan   [ Time Frame: Baseline, Day 1, 57, 113 ]

9.  Secondary:   Pharmacokinetics (PK) Parameter of Cmax   [ Time Frame: Day 1 ]

10.  Secondary:   Time to Reach the Maximum Concentration After Drug Administration (Tmax)   [ Time Frame: Day 1 ]


  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 Pharmaceutical
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02250443     History of Changes
Other Study ID Numbers: CBYM338X2205E1
First Submitted: March 20, 2014
First Posted: September 26, 2014
Results First Submitted: August 9, 2017
Results First Posted: April 10, 2018
Last Update Posted: April 10, 2018