NCT02468674

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2015

Typical duration for phase_2

Geographic Reach
12 countries

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 22, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 9, 2019

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

3.4 years

First QC Date

April 30, 2015

Results QC Date

October 24, 2019

Last Update Submit

June 15, 2020

Conditions

Sarcopenia

Keywords

Sarcopenia, muscle wasting, elderly, strength, physical function, lean body mass, gait speed

Outcome Measures

Primary Outcomes (2)

  • 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 (8)

  • Population I: 6-minute Walking Distance (6MWT) at Week 49

    Week 49

  • Population II: 6-minute Walking Distance (6MWT) at Week 49

    Week 49

  • Population I: Gait Speed at Week 49

    Week 49

  • Population II: Gait Speed at Week 49

    Week 49

  • Population I: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49

    Week 49

  • +3 more secondary outcomes

Study Arms (2)

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.

Drug: bimagrumabDrug: 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

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.

Follow-up (arm 1)
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.

Follow-up (arm 1)

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (30)

Novartis Investigative Site

Miami Lakes, Florida, 33014, United States

Location

Novartis Investigative Site

Gainesville, Georgia, 30501, United States

Location

Novartis Investigative Site

Spartanburg, South Carolina, 29303, United States

Location

Novartis Investigative Site

San Antonio, Texas, 78229, United States

Location

Novartis Investigative Site

Madison, Wisconsin, 53705, United States

Location

Novartis Investigative Site

St Albans, Victoria, 3021, Australia

Location

Novartis Investigative Site

Brussels, 1090, Belgium

Location

Novartis Investigative Site

Prague, 12000, Czechia

Location

Novartis Investigative Site

Copenhagen NV, 2400, Denmark

Location

Novartis Investigative Site

Montpellier, 34295, France

Location

Novartis Investigative Site

Pessac, 33604, France

Location

Novartis Investigative Site

Ōbu, Aichi-ken, 474-8511, Japan

Location

Novartis Investigative Site

Toyohashi, Aichi-ken, 440-8510, Japan

Location

Novartis Investigative Site

Mizunami, Gifu, 509 6134, Japan

Location

Novartis Investigative Site

Nara, Nara, 630-8581, Japan

Location

Novartis Investigative Site

Kawachi-Nagano, Osaka, 586-8521, Japan

Location

Novartis Investigative Site

Kitaadachigun Inamachi, Saitama, 362-0806, Japan

Location

Novartis Investigative Site

Kitamoto, Saitama, 364-8501, Japan

Location

Novartis Investigative Site

Itabashi Ku, Tokyo, 173 0015, Japan

Location

Novartis Investigative Site

Kiyose, Tokyo, 204-0021, Japan

Location

Novartis Investigative Site

Koto-ku, Tokyo, 136-0075, Japan

Location

Novartis Investigative Site

Moscow, 101990, Russia

Location

Novartis Investigative Site

Moscow, 117997, Russia

Location

Novartis Investigative Site

Saint Petersburg, 190068, Russia

Location

Novartis Investigative Site

Yaroslavl, 150003, Russia

Location

Novartis Investigative Site

Suwon, Gyeonggi-do, 16499, South Korea

Location

Novartis Investigative Site

Albacete, Castille-La Mancha, 02006, Spain

Location

Novartis Investigative Site

Getafe, Madrid, 28905, Spain

Location

Novartis Investigative Site

Geneva, 1211, Switzerland

Location

Novartis Investigative Site

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

SarcopeniaMuscular Atrophy

Interventions

bimagrumab

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@novartis.com
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2015

First Posted

June 11, 2015

Study Start

July 22, 2015

Primary Completion

December 3, 2018

Study Completion

December 3, 2018

Last Updated

June 16, 2020

Results First Posted

December 9, 2019

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

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

Locations

US(5)CH(1)CZ(1)RU(4)KR(1)BE(1)DK(1)JP(10)AU(1)FR(2)ES(2)TW(1)