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A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468674
Recruitment Status : Completed
First Posted : June 11, 2015
Results First Posted : December 9, 2019
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Sarcopenia Drug: bimagrumab Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 22, 2015
Actual Primary Completion Date : December 3, 2018
Actual Study Completion Date : December 3, 2018

Arm Intervention/treatment
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.
Drug: bimagrumab

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.


Drug: Placebo

Placebo

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.


No Intervention: 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.



Primary Outcome Measures :
  1. Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49 [ Time Frame: 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).

  2. Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49 [ Time Frame: 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).


Secondary Outcome Measures :
  1. Population I: 6-minute Walking Distance (6MWT) at Week 49 [ Time Frame: 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.

  2. Population II: 6-minute Walking Distance (6MWT) at Week 49 [ Time Frame: 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.

  3. Population I: Gait Speed at Week 49 [ Time Frame: 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.

  4. Population II: Gait Speed at Week 49 [ Time Frame: 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.

  5. Population I: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 [ Time Frame: 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.

  6. Population II: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 [ Time Frame: 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.

  7. Population I: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 [ Time Frame: Week 49 ]
    LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect

  8. Population II: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49 [ Time Frame: Week 49 ]
    LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468674


Locations
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United States, Florida
Novartis Investigative Site
Miami Lakes, Florida, United States, 33014
United States, Georgia
Novartis Investigative Site
Gainesville, Georgia, United States, 30501
United States, South Carolina
Novartis Investigative Site
Spartanburg, South Carolina, United States, 29303
United States, Texas
Novartis Investigative Site
San Antonio, Texas, United States, 78229
United States, Wisconsin
Novartis Investigative Site
Madison, Wisconsin, United States, 53705
Australia, Victoria
Novartis Investigative Site
St Albans, Victoria, Australia, 3021
Belgium
Novartis Investigative Site
Brussel, Belgium, 1090
Czechia
Novartis Investigative Site
Praha 2, Czechia, 12000
Denmark
Novartis Investigative Site
Copenhagen NV, Denmark, 2400
France
Novartis Investigative Site
Montpellier, France, 34295
Novartis Investigative Site
Pessac, France, 33604
Japan
Novartis Investigative Site
Obu-city, Aichi, Japan, 474-8511
Novartis Investigative Site
Toyohashi-city, Aichi, Japan, 440-8510
Novartis Investigative Site
Mizunami-city, Gifu, Japan, 509 6134
Novartis Investigative Site
Nara-city, Nara, Japan, 630-8581
Novartis Investigative Site
Kawachinagano, Osaka, Japan, 586-8521
Novartis Investigative Site
Kitaadachigun Inamachi, Saitama, Japan, 362-0806
Novartis Investigative Site
Kitamoto-city, Saitama, Japan, 364-8501
Novartis Investigative Site
Itabashi ku, Tokyo, Japan, 173 0015
Novartis Investigative Site
Kiyose-city, Tokyo, Japan, 204-0021
Novartis Investigative Site
Koto-ku, Tokyo, Japan, 136-0075
Korea, Republic of
Novartis Investigative Site
Suwon si, Gyeonggi Do, Korea, Republic of, 16499
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation, 101990
Novartis Investigative Site
Moscow, Russian Federation, 117997
Novartis Investigative Site
St Petersburg, Russian Federation, 190068
Novartis Investigative Site
Yaroslavl, Russian Federation, 150003
Spain
Novartis Investigative Site
Albacete, Castilla La Mancha, Spain, 02006
Novartis Investigative Site
Getafe, Madrid, Spain, 28905
Switzerland
Novartis Investigative Site
Genève 14, Switzerland, 1211
Taiwan
Novartis Investigative Site
Taipei, Taiwan, 11217
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] April 26, 2017
Statistical Analysis Plan  [PDF] August 14, 2018

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02468674    
Other Study ID Numbers: CBYM338E2202E1
2015-000471-27 ( EudraCT Number )
First Posted: June 11, 2015    Key Record Dates
Results First Posted: December 9, 2019
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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 trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Sarcopenia, muscle wasting, elderly, strength, physical function, lean body mass, gait speed
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical