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

Sarcopenia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02468674
• Other study ID #: CBYM338E2202E1
• Secondary ID: 2015-000471-27
• Status: Completed
• Phase: Phase 2
• Start date: July 22, 2015
• Est. completion date: December 3, 2018

Study information

• Verified date: June 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 3, 2018
• Est. primary completion date: December 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	St Albans	Victoria
Belgium	Novartis Investigative Site	Brussel
Czechia	Novartis Investigative Site	Praha 2
Denmark	Novartis Investigative Site	Copenhagen NV
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Pessac
Japan	Novartis Investigative Site	Itabashi ku	Tokyo
Japan	Novartis Investigative Site	Kawachinagano	Osaka
Japan	Novartis Investigative Site	Kitaadachigun Inamachi	Saitama
Japan	Novartis Investigative Site	Kitamoto-city	Saitama
Japan	Novartis Investigative Site	Kiyose-city	Tokyo
Japan	Novartis Investigative Site	Koto-ku	Tokyo
Japan	Novartis Investigative Site	Mizunami-city	Gifu
Japan	Novartis Investigative Site	Nara-city	Nara
Japan	Novartis Investigative Site	Obu-city	Aichi
Japan	Novartis Investigative Site	Toyohashi-city	Aichi
Korea, Republic of	Novartis Investigative Site	Suwon si	Gyeonggi Do
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	Yaroslavl
Spain	Novartis Investigative Site	Albacete	Castilla La Mancha
Spain	Novartis Investigative Site	Getafe	Madrid
Switzerland	Novartis Investigative Site	Genève 14
Taiwan	Novartis Investigative Site	Taipei
United States	Novartis Investigative Site	Gainesville	Georgia
United States	Novartis Investigative Site	Madison	Wisconsin
United States	Novartis Investigative Site	Miami Lakes	Florida
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Czechia,  Denmark,  France,  Japan,  Korea, Republic of,  Russian Federation,  Spain,  Switzerland,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	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).	Week 49
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.	Week 49
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.	Week 49
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.	Week 49
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.	Week 49
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.	Week 49
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.	Week 49
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	Week 49
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	Week 49