SarcopeniaPhase 2NCT02468674

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

A Phase 2 study testing bimagrumab in people with Sarcopenia, run by Novartis Pharmaceuticals at 30 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 70 years and older
Conditions the study is for: Sarcopenia
What is being tested?: bimagrumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 30 sitesin 12 countries
Study dates: 22 Jul 2015to 3 Dec 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 70 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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)

Who cannot join

Any condition which should have led to treatment discontinuation per protocol in the core study (CBYM338E2202)

Trial locations and contacts

30 sites in 12 countries.

Country

City, postcode or hospital

30 sites in 12 countries

Japan10 sites

Novartis Investigative Site
Itabashi Ku, Tokyo, 173 0015
Novartis Investigative Site
Kawachi-Nagano, Osaka, 586-8521
Novartis Investigative Site
Kitaadachigun Inamachi, Saitama, 362-0806
Novartis Investigative Site
Kitamoto, Saitama, 364-8501
Novartis Investigative Site
Kiyose, Tokyo, 204-0021
Novartis Investigative Site
Koto-ku, Tokyo, 136-0075
Novartis Investigative Site
Mizunami, Gifu, 509 6134
Novartis Investigative Site
Nara, Nara, 630-8581
Novartis Investigative Site
Ōbu, Aichi-ken, 474-8511
Novartis Investigative Site
Toyohashi, Aichi-ken, 440-8510

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United States5 sites

Novartis Investigative Site
Gainesville, Georgia, 30501
Novartis Investigative Site
Madison, Wisconsin, 53705
Novartis Investigative Site
Miami Lakes, Florida, 33014
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
Spartanburg, South Carolina, 29303

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Russia4 sites

Novartis Investigative Site
Moscow, 101990
Novartis Investigative Site
Moscow, 117997
Novartis Investigative Site
Saint Petersburg, 190068
Novartis Investigative Site
Yaroslavl, 150003

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France2 sites

Novartis Investigative Site
Montpellier, 34295
Novartis Investigative Site
Pessac, 33604

Other trials in France

Spain2 sites

Novartis Investigative Site
Albacete, Castille-La Mancha, 02006
Novartis Investigative Site
Getafe, Madrid, 28905

Other trials in Spain

Australia1 site

Novartis Investigative Site
St Albans, Victoria, 3021

Other trials in Australia

Belgium1 site

Novartis Investigative Site
Brussels, 1090

Other trials in Belgium

Czechia1 site

Novartis Investigative Site
Prague, 12000

Other trials in Czechia

Denmark1 site

Novartis Investigative Site
Copenhagen NV, 2400

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South Korea1 site

Novartis Investigative Site
Suwon, Gyeonggi-do, 16499

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Switzerland1 site

Novartis Investigative Site
Geneva, 1211

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Taiwan1 site

Novartis Investigative Site
Taipei, 11217

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About this 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)

Read the 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.

Conditions: Sarcopenia
Being tested: bimagrumab, Placebo
Keywords: Sarcopenia, muscle wasting, elderly, strength, physical function, lean body mass, gait speed
Medical subject headings: Sarcopenia, Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bimagrumabDrug
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.
PlaceboDrug
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.

Study groups in NCT02468674
Study group	Role	What they receive
Follow-up (arm 1)	Other	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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: Week 49

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Week 49

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 20153 Dec 2018

First posted11 Jun 2015 (estimated)
Study start22 Jul 2015
Primary completion3 Dec 2018
Study completion3 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SarcopeniaStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02468674
Sponsor's protocol ID: CBYM338E2202E1
Other IDs: 2015-000471-27, 2015
Status last verified: Jun 2020
First submitted: 30 Apr 2015
Last updated: 16 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02468674
Acronym / sponsor ID: CBYM338E2202E1
Conditions: Sarcopenia
Keywords: Sarcopenia, muscle wasting, elderly, strength, physical function, lean body mass, gait speed
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 22 Jul 2015 (actual)
Primary completion: 3 Dec 2018 (actual)
Study completion: 3 Dec 2018 (actual)
First posted: 11 Jun 2015 (estimated)
Results: Posted 9 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Follow-up (arm 1)	Other	Drug: bimagrumab, Drug: PlaceboPatients 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.
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.

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (1 listed)

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)

Key exclusion criteria (1 listed)

Any condition which should have led to treatment discontinuation per protocol in the core study (CBYM338E2202)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bimagrumabbimagrumab 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	Follow-up (arm 1)
PlaceboPlacebo 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.	Drug	Follow-up (arm 1)

Primary outcome

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).
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).

8 secondary outcomes

Population I: 6-minute Walking Distance (6MWT) at Week 49
Time frame: Week 49
Population II: 6-minute Walking Distance (6MWT) at Week 49
Time frame: Week 49
Population I: Gait Speed at Week 49
Time frame: Week 49
Population II: Gait Speed at Week 49
Time frame: Week 49
Population I: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
Time frame: Week 49
Population II: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
Time frame: Week 49
Population I: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
Time frame: Week 49
Population II: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
Time frame: Week 49

Results and safety

Results posted to the registry on 9 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Population I: BYM338 700 mg	5	4
Population I BYM338: 700 mg to Placebo	5	5
Population I: BYM338 210 mg	5	5
Population I BYM338: 210 mg to Placebo	4	3
Population I: BYM338 70 mg	7	6
Population I: BYM338 70 mg to Placebo	7	6
Population I: Placebo	15	14
Population: II BYM338 700 mg	69	65
Population: II Placebo	43	40

Primary outcome: Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49

Time frame: Week 49. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Population I: BYM338 700 mg n = 4	Population I BYM338: 700 mg to Placebo n = 5	Population I: BYM338 210 mg n = 5	Population I BYM338: 210 mg to Placebo n = 3	Population I: BYM338 70 mg n = 6	Population I: BYM338 70 mg to Placebo n = 6	Population I: Placebo n = 14
Value	8.8 (3.86)	10.2 (1.92)	8.0 (2.35)	8.0 (2.65)	9.5 (2.17)	7.5 (3.78)	9.6 (1.83)

Population I: BYM338 700 mg vs Population I BYM338: 700 mg to Placebo: p = 0.759, t-test, 1 sided
Population I: BYM338 210 mg vs Population I BYM338: 210 mg to Placebo: p = 0.500, t-test, 1 sided
Population I: BYM338 70 mg vs Population I: BYM338 70 mg to Placebo: p = 0.144, t-test, 1 sided

Population analysed: 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.

Primary outcome: Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49

Time frame: Week 49. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Population: II BYM338 700 mg n = 65	Population: II Placebo n = 40
Value	8.6 (2.40)	8.8 (1.55)

Population: II BYM338 700 mg vs Population: II Placebo: p = 0.839, ANCOVA

8 secondary outcomes are reported in the full results.

Adverse events

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. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Population I BYM338 700 mg	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Population I BYM338 700 mg to Placebo	1 of 5 (20%)	4 of 5 (80%)	0 of 5
Population I BYM338 210 mg	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Population I BYM338 210 mg to Placebo	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Population I BYM338 70 mg	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7
Population I BYM338 70 mg to Placebo	2 of 7 (28.6%)	3 of 7 (42.9%)	0 of 7
Population I Placebo	2 of 15 (13.3%)	11 of 15 (73.3%)	0 of 15
Population: II BYM338 700 mg	0 of 69 (0%)	0 of 69 (0%)	0 of 69
Population: II Placebo	0 of 43 (0%)	0 of 43 (0%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

30 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bimagrumab in people with Sarcopenia, run by Novartis Pharmaceuticals at 30 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Japan, United States, Russia, France, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49 (time frame: Week 49). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02468674.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.