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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02573467




Registration number
NCT02573467
Ethics application status
Date submitted
9/07/2015
Date registered
9/10/2015
Date last updated
13/03/2018

Titles & IDs
Public title
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
Scientific title
Extension of the CBYM338B2203 Phase IIb/III Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Intravenous BYM338 in Patients With Sporadic Inclusion Body Myositis
Secondary ID [1] 0 0
2015-001411-12
Secondary ID [2] 0 0
CBYM338B2203E1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sporadic Inclusion Body Myositis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bimagrumab
Treatment: Drugs - Placebo

Experimental: 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.

Experimental: 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.

Experimental: 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 comparator: Placebo - Participants received placebo 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.


Treatment: Drugs: 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.

Treatment: Drugs: Placebo
Matching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.
Timepoint [1] 0 0
to end of study (up to 14 months, including the 6-month treatment-free follow-up period)
Primary outcome [2] 0 0
Change From Core Study Baseline in 6 Minute Walking Distance Test (6MWD)
Timepoint [2] 0 0
Core study baseline, weeks 52, 78, 104, and >=117
Secondary outcome [1] 0 0
Change From Core Study Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side
Timepoint [1] 0 0
Core study baseline, week 52, week 78, week 104 and >=week 117
Secondary outcome [2] 0 0
Change From Core Study Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score
Timepoint [2] 0 0
Core study baseline, week 52, week 78, week 104, and >=week 117
Secondary outcome [3] 0 0
Estimated Annual Number of Falls Per Participant Within Treatment Group
Timepoint [3] 0 0
Core baseline to end of extension double-blind treatment (up to a maximum of 32 months)
Secondary outcome [4] 0 0
Change From Core Study Baseline in Short Physical Performance Battery (SPPB) Score
Timepoint [4] 0 0
Core study baseline, week 52, week 78, week 104 and >=week 117
Secondary outcome [5] 0 0
Change in Muscles of the Thigh
Timepoint [5] 0 0
up to 1 year, up to 2 years
Secondary outcome [6] 0 0
Number of Patients With Anti-BYM338 Antibodies
Timepoint [6] 0 0
end of double-blind treatment (up to 8 months)

Eligibility
Key inclusion criteria
* Patients who completed the core study
* Written informed consent must be obtained before any extension study assessment is performed.
* Able to communicate well with the investigator.
* Willing to participate for the entire duration of the extension study with commitment to follow study requirements and procedures.
Minimum age
36 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who are pregnant
* Women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 6 months after the last BYM338 dose.
* Current use of prohibited treatments
* History of severe hypersensitivity reaction in the core study
* History of adverse event(s) (including those from the core study) prior to the start of study drug in the extension study that, in the judgment of the investigator, taking into account the subject's overall status, prevent the subject from entering the extension study
* Clinically significant abnormal liver function tests
* Any medical condition or laboratory finding which, in the opinion of the investigator may interfere with participation in the study, might confound the results of the study, or pose an additional safety risk in administering BYM338

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/02/2017
Sample size
Target
Accrual to date
Final
211
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - St. Leonards
Recruitment hospital [2] 0 0
Novartis Investigative Site - Cauldfield
Recruitment hospital [3] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
3162 - Cauldfield
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Belgium
State/province [10] 0 0
Antwerpen
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Denmark
State/province [13] 0 0
Copenhagen
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
Italy
State/province [15] 0 0
BS
Country [16] 0 0
Italy
State/province [16] 0 0
Lazio
Country [17] 0 0
Italy
State/province [17] 0 0
ME
Country [18] 0 0
Italy
State/province [18] 0 0
MI
Country [19] 0 0
Italy
State/province [19] 0 0
PD
Country [20] 0 0
Japan
State/province [20] 0 0
Aichi
Country [21] 0 0
Japan
State/province [21] 0 0
Kumamoto
Country [22] 0 0
Japan
State/province [22] 0 0
Miyagi
Country [23] 0 0
Japan
State/province [23] 0 0
Osaka
Country [24] 0 0
Japan
State/province [24] 0 0
Tokyo
Country [25] 0 0
Japan
State/province [25] 0 0
Wakayama
Country [26] 0 0
Japan
State/province [26] 0 0
Tokushima
Country [27] 0 0
Netherlands
State/province [27] 0 0
Amsterdam
Country [28] 0 0
Netherlands
State/province [28] 0 0
Leiden
Country [29] 0 0
Switzerland
State/province [29] 0 0
Zuerich
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Manchester
Country [31] 0 0
United Kingdom
State/province [31] 0 0
London
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02573467