A 24-week Off-drug Extension Study in Sarcopenic Elderly... | NCT02468674 | Trialant
NCT02468674
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Jun 16, 2020Actual
Enrollment
160Actual
Phase
Phase 2
Conditions
Sarcopenia
Interventions
bimagrumab
Placebo
Countries
United States
Australia
Belgium
Czechia
Denmark
France
Japan
Russia
South Korea
Spain
Switzerland
Taiwan
Protocol Section
Identification Module
NCT ID
NCT02468674
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CBYM338E2202E1
Secondary IDs
ID
Type
Description
Link
2015-000471-27
EudraCT Number
Brief Title
A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study
Official Title
A 24 Week Off Drug Extension, Parallel Group, Study Assessing Durability of Effect on Skeletal Muscle Strength and Function Following a 6-month Double-blind, Placebo Controlled Study Evaluating Bimagrumab in Older Adults With Sarcopenia (InvestiGAIT Extension)
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jun 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 22, 2015Actual
Primary Completion Date
Dec 3, 2018Actual
Completion Date
Dec 3, 2018Actual
First Submitted Date
Apr 30, 2015
First Submission Date that Met QC Criteria
Jun 8, 2015
First Posted Date
Jun 11, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 24, 2019
Results First Submitted that Met QC Criteria
Dec 5, 2019
Results First Posted Date
Dec 9, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 15, 2020
Last Update Posted Date
Jun 16, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This extension study was a 24-week off-drug follow-up of the core CBYM338E2202 (NCT ) study and the main objective was to determine the long-term durability of bimagrumab (BYM338) effect after a 6-month treatment period.
Detailed Description
Two populations were defined as below:
Population I: Patients enrolled prior to the protocol amendment 1, who received bimagrumab 70 mg, 210 mg or 700 mg in the core study, were randomly assigned to two subgroups within each of three treatment arms to either receive bimagrumab at the same dose level or placebo. Patients receiving placebo in the core study continued receiving placebo in the extension study.
Population II: Patients enrolled after protocol amendment 1, who received bimagrumab 700 mg or placebo in the core study, did not receive study medication in the extension study and were followed-up per schedule defined in this protocol amendment.
Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
Drug: bimagrumab
Drug: Placebo
Follow-up (arm 2)
No Intervention
Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
bimagrumab
Drug
bimagrumab low dose bimagrumab moderate dose bimagrumab high dose
Patients enrolled prior to the protocol amendment 1 (Population I ), who received bimagrumab in the core study, entered the extension study at Week 25 and were randomly assigned to two subgroups within each of three treatment arms to either receive bimagrumab at the same dose level or placebo. Study medication was administered as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49
SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
Week 49
Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49
SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
Week 49
Secondary Outcomes
Measure
Description
Time Frame
Population I: 6-minute Walking Distance (6MWT) at Week 49
The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. A high 6MWT represent better physical condition.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criterion:
- Men and postmenopausal women aged 70 years or older that have participated in, and have completed the full study treatment period per protocol (24 weeks/EOT visit) in the preceding core study (CBYM338E2202)
Exclusion criterion:
- Any condition which should have led to treatment discontinuation per protocol in the core study (CBYM338E2202)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
70 Years
Maximum Age
Not provided
Standard Ages
Older 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
Miami Lakes
Florida
33014
United States
Novartis Investigative Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This study was conducted in 30 centers in 12 countries: Australia (1), Belgium (1), Czech Republic (1), Denmark (1), France (2), Japan (10), Russia (4), South Korea (1), Spain (2), Switzerland (1), Taiwan (1), United States (5).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Population I: BYM338 700 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
FG001
Population I BYM338: 700 mg to Placebo
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
All randomized patients were included in the Full Analysis (FAS) and Safety Set
Patients enrolled prior to the protocol amendment 1 (Population I), who received placebo in core study, entered the extension study at Week 25 and received placebo as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45.
Follow-up (arm 1)
Week 49
Population II: 6-minute Walking Distance (6MWT) at Week 49
The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. A high 6MWT represent better physical condition.
Week 49
Population I: Gait Speed at Week 49
Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed.
Week 49
Population II: Gait Speed at Week 49
Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed.
Week 49
Population I: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
ASMI is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.
Week 49
Population II: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
ASMI is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.
Week 49
Population I: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect
Week 49
Population II: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect
Week 49
Gainesville
Georgia
30501
United States
Novartis Investigative Site
Spartanburg
South Carolina
29303
United States
Novartis Investigative Site
San Antonio
Texas
78229
United States
Novartis Investigative Site
Madison
Wisconsin
53705
United States
Novartis Investigative Site
St Albans
Victoria
3021
Australia
Novartis Investigative Site
Brussels
1090
Belgium
Novartis Investigative Site
Prague
12000
Czechia
Novartis Investigative Site
Copenhagen NV
2400
Denmark
Novartis Investigative Site
Montpellier
34295
France
Novartis Investigative Site
Pessac
33604
France
Novartis Investigative Site
Ōbu
Aichi-ken
474-8511
Japan
Novartis Investigative Site
Toyohashi
Aichi-ken
440-8510
Japan
Novartis Investigative Site
Mizunami
Gifu
509 6134
Japan
Novartis Investigative Site
Nara
Nara
630-8581
Japan
Novartis Investigative Site
Kawachi-Nagano
Osaka
586-8521
Japan
Novartis Investigative Site
Kitaadachigun Inamachi
Saitama
362-0806
Japan
Novartis Investigative Site
Kitamoto
Saitama
364-8501
Japan
Novartis Investigative Site
Itabashi Ku
Tokyo
173 0015
Japan
Novartis Investigative Site
Kiyose
Tokyo
204-0021
Japan
Novartis Investigative Site
Koto-ku
Tokyo
136-0075
Japan
Novartis Investigative Site
Moscow
101990
Russia
Novartis Investigative Site
Moscow
117997
Russia
Novartis Investigative Site
Saint Petersburg
190068
Russia
Novartis Investigative Site
Yaroslavl
150003
Russia
Novartis Investigative Site
Suwon
Gyeonggi-do
16499
South Korea
Novartis Investigative Site
Albacete
Castille-La Mancha
02006
Spain
Novartis Investigative Site
Getafe
Madrid
28905
Spain
Novartis Investigative Site
Geneva
1211
Switzerland
Novartis Investigative Site
Taipei
11217
Taiwan
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
FG002
Population I: BYM338 210 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
FG003
Population I BYM338: 210 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
FG004
Population I: BYM338 70 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
FG005
Population I: BYM338 70 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
FG006
Population I: Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
FG007
Population: II BYM338 700 mg
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
FG008
Population: II Placebo
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
FG0005 subjects
FG0015 subjects
FG0025 subjects
FG0034 subjects
FG0047 subjects
FG0057 subjects
FG00615 subjects
FG00769 subjects
FG00843 subjects
COMPLETED
FG0004 subjects
FG0015 subjects
FG0025 subjects
FG0033 subjects
FG0046 subjects
FG0056 subjects
FG00614 subjects
FG00765 subjects
FG00840 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
FG0074 subjects
FG0083 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Patient/Guardian Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Population I: BYM338 700 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
BG001
Population I BYM338: 700 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
BG002
Population I: BYM338 210 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
BG003
Population I BYM338: 210 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
BG004
Population I: BYM338 70 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
BG005
Population I: BYM338 70 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
BG006
Population I: Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
BG007
Population: II BYM338 700 mg
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
BG008
Population: II Placebo
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0005
BG0015
BG0025
BG0034
BG0047
BG0057
BG00615
BG00769
BG00843
BG009160
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Age Continuous for Population I
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
Mean
Standard Deviation
Years
Title
Denominators
Categories
ParticipantsBG0005
ParticipantsBG0015
ParticipantsBG0025
ParticipantsBG003
Age, Continuous
Age Continuous for Population II
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
Mean
Standard Deviation
Years
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Sex: Female, Male
Gender for Population I
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0005
ParticipantsBG0015
ParticipantsBG002
Sex: Female, Male
Gender for Population II
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Race/Ethnicity, Customized
Race/Ethnicity for Population I
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
Number
Participants
Title
Denominators
Categories
Asian
ParticipantsBG0005
ParticipantsBG0015
ParticipantsBG002
Race/Ethnicity, Customized
Race/Ethnicity for Population II
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
Number
Participants
Title
Denominators
Categories
Asian
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Population I: Short Physical Performance Battery (SPPB) total score at Week 25
Baseline Extension Visit = Week 25. SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
Mean
Standard Deviation
Scores on a scale
Title
Denominators
Categories
ParticipantsBG0005
ParticipantsBG001
Population II: Short Physical Performance Battery (SPPB) total score at Week 25
Baseline Extension Visit = Week 25. SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
Mean
Standard Deviation
Scores on a scale
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG001
Population I: 6-minute walking distance (6MWT) at Week 25
Baseline Extension Visit = Week 25. The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway.
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
Mean
Standard Deviation
meters
Title
Denominators
Categories
ParticipantsBG0005
ParticipantsBG001
Population II: 6-minute walking distance (6MWT) at Week 25
Baseline Extension Visit = Week 25. The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway.
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
Mean
Standard Deviation
meters
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG001
Population I: Gait speed at Week 25
Baseline Extension Visit = Week 25. Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed.
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
Mean
Standard Deviation
m/sec
Title
Denominators
Categories
ParticipantsBG0005
ParticipantsBG001
Population II: Gait speed at Week 25
Baseline Extension Visit = Week 25. Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed.
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
Mean
Standard Deviation
m/sec
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49
SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
Posted
Mean
Standard Deviation
Scores on a scale
Week 49
ID
Title
Description
OG000
Population I: BYM338 700 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG001
Population I BYM338: 700 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG002
Population I: BYM338 210 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG003
Population I BYM338: 210 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG004
Population I: BYM338 70 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG005
Population I: BYM338 70 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG006
Population I: Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
Units
Counts
Participants
OG0004
OG0015
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0008.8± 3.86
OG00110.2± 1.92
OG0028.0± 2.35
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Population I: SPPB total score at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance level.
0.759
Other
OG002
OG003
Population I: SPPB total score at Week 49
Primary
Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49
SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
Posted
Mean
Standard Deviation
Scores on a scale
Week 49
ID
Title
Description
OG000
Population: II BYM338 700 mg
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
OG001
Population: II Placebo
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
Units
Counts
Secondary
Population I: 6-minute Walking Distance (6MWT) at Week 49
The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. A high 6MWT represent better physical condition.
The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
Posted
Mean
Standard Deviation
meters
Week 49
ID
Title
Description
OG000
Population I: BYM338 700 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG001
Population I BYM338: 700 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG002
Secondary
Population II: 6-minute Walking Distance (6MWT) at Week 49
The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. A high 6MWT represent better physical condition.
The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
Posted
Mean
Standard Deviation
meters
Week 49
ID
Title
Description
OG000
Population: II BYM338 700 mg
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
OG001
Population: II Placebo
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
Secondary
Population I: Gait Speed at Week 49
Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed.
The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
Posted
Mean
Standard Deviation
m/sec
Week 49
ID
Title
Description
OG000
Population I: BYM338 700 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG001
Population I BYM338: 700 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG002
Population I: BYM338 210 mg
Secondary
Population II: Gait Speed at Week 49
Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed.
The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
Posted
Mean
Standard Deviation
m/sec
Week 49
ID
Title
Description
OG000
Population: II BYM338 700 mg
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
OG001
Population: II Placebo
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
Units
Counts
Secondary
Population I: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
ASMI is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.
The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
Posted
Geometric Mean
Geometric Coefficient of Variation
kg/m^2
Week 49
ID
Title
Description
OG000
Population I: BYM338 700 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG001
Population I BYM338: 700 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
Secondary
Population II: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
ASMI is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.
The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
Posted
Geometric Mean
Geometric Coefficient of Variation
kg/m^2
Week 49
ID
Title
Description
OG000
Population: II BYM338 700 mg
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
OG001
Population: II Placebo
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
Secondary
Population I: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect
The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
Posted
Geometric Mean
Geometric Coefficient of Variation
kg
Week 49
ID
Title
Description
OG000
Population I: BYM338 700 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG001
Population I BYM338: 700 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG002
Population I: BYM338 210 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
Secondary
Population II: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect
The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
Posted
Geometric Mean
Geometric Coefficient of Variation
kg
Week 49
ID
Title
Description
OG000
Population: II BYM338 700 mg
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
OG001
Population: II Placebo
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
Units
Counts
Participants
Time Frame
Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Description
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Population I BYM338 700 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
0
5
0
5
4
5
EG001
Population I BYM338 700 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
0
5
1
5
4
5
EG002
Population I BYM338 210 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
0
5
0
5
3
5
EG003
Population I BYM338 210 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
0
4
0
4
2
4
EG004
Population I BYM338 70 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
0
7
0
7
5
7
EG005
Population I BYM338 70 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
0
7
2
7
3
7
EG006
Population I Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
0
15
2
15
11
15
EG007
Population: II BYM338 700 mg
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
0
69
0
69
0
69
EG008
Population: II Placebo
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
0
43
0
43
0
43
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cataract
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG0030 affected4 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected69 at risk
EG0080 affected43 at risk
Fall
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Gallbladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Seizure
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bundle branch block left
Cardiac disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG0030 affected4 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0061 affected15 at risk
EG0070 affected69 at risk
EG0080 affected43 at risk
Ventricular extrasystoles
Cardiac disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Dry eye
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected5 at risk
EG003
Eye irritation
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Macular degeneration
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Fatigue
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected5 at risk
EG003
Influenza like illness
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Peripheral swelling
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected5 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Cystitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Gingivitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected5 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected5 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected5 at risk
EG0020 affected5 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Muscle contusion
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Body mass index decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Lipase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected5 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Device loosening
Product Issues
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected5 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Prostatic dysplasia
Reproductive system and breast disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Hypertension
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG003
Population I BYM338: 210 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG004
Population I: BYM338 70 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG005
Population I: BYM338 70 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG006
Population I: Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
Units
Counts
Participants
OG0005
OG0015
OG0025
OG0034
OG0047
OG0057
OG00615
Title
Denominators
Categories
Title
Measurements
OG000318.2± 159.55
OG001354.1± 69.98
OG002304.1± 63.05
OG003361.5± 144.53
OG004316.1± 97.87
OG005273.4± 154.03
OG006368.7± 108.37
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Population I: 6MWT at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance level.
0.669
Other
OG002
OG003
Population I: 6MWT at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance level.
0.773
Other
OG004
OG005
Population I: 6MWT at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance level.
0.290
Other
OG000
OG006
Population I: 6MWT at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance level.
0.766
Other
OG002
OG006
Population I: 6MWT at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance level.
0.885
Other
OG004
OG006
Population I: 6MWT at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance level.
0.840
Other
Units
Counts
Participants
OG00069
OG00143
Title
Denominators
Categories
Title
Measurements
OG000321.2± 105.13
OG001323.1± 96.47
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Population II: 6MWT at Week 49
ANCOVA
Difference in the least square means (SE)
0.367
Other
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG003
Population I BYM338: 210 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG004
Population I: BYM338 70 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG005
Population I: BYM338 70 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG006
Population I: Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
Units
Counts
Participants
OG0005
OG0015
OG0025
OG0034
OG0047
OG0057
OG00615
Title
Denominators
Categories
Title
Measurements
OG0000.8± 0.35
OG0011.0± 0.18
OG0020.9± 0.17
OG0031.1± 0.24
OG0040.9± 0.15
OG0050.7± 0.35
OG0060.8± 0.18
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Population I: Gait speed at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance
0.875
Other
OG002
OG003
Population I: Gait speed at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance
0.909
Other
OG004
OG005
Population I: Gait speed at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance
0.168
Other
OG000
OG006
Population I: Gait speed at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance
0.632
Other
OG002
OG006
Population I: Gait speed at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance
0.310
Other
OG004
OG006
Population I: Gait speed at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance
0.321
Other
Participants
OG00069
OG00143
Title
Denominators
Categories
Title
Measurements
OG0000.9± 0.24
OG0010.9± 0.17
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Population II: Gait speed at Week 49
ANCOVA
Difference in the least square means (SE)
0.395
Other
OG002
Population I: BYM338 210 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG003
Population I BYM338: 210 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG004
Population I: BYM338 70 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG005
Population I: BYM338 70 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG006
Population I: Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
Units
Counts
Participants
OG0005
OG0015
OG0025
OG0034
OG0047
OG0057
OG00615
Title
Denominators
Categories
Title
Measurements
OG0006.6± 7.22
OG0016.0± 14.05
OG0026.1± 8.08
OG0035.8± 15.08
OG0045.9± 14.19
OG0055.2± 14.85
OG0065.6± 15.21
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Population I: ASMI at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance level.
0.120
Other
OG002
OG003
Population I: ASMI at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance level.
0.297
Other
OG004
OG005
Population I: ASMI at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance level.
0.074
Other
OG000
OG006
Population I: ASMI at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance level.
0.022
Other
OG002
OG006
Population I: ASMI at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance level.
0.106
Other
OG004
OG006
Population I: ASMI at Week 49
t-test, 1 sided
One-sided test at the 0.025 significance level.
0.211
Other
Units
Counts
Participants
OG00069
OG00143
Title
Denominators
Categories
Title
Measurements
OG0005.6± 14.36
OG0015.5± 12.46
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Population II: ASMI at Week 49
ANCOVA
Difference in the least square geometric means
1.000
Other
OG003
Population I BYM338: 210 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG004
Population I: BYM338 70 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG005
Population I: BYM338 70 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
OG006
Population I: Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.