Clinical Trial: A Randomized Withdrawal Extension Study of Bimagrumab 70, 210, 700 mg in Older Adults With Sarcopenia Previously Participating in the Core Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A 28 Week Randomized Withdrawal Extension of a Double-blind, Placebo-controlled, Parallel Group Study to Assess Durability of Effect on Skeletal Muscle Strength and Function Upon Withdrawal of Bimagru

Brief Summary:

The purpose of this extension study is to: 1) evaluate the durability of effect on skeletal muscle mass, strength and physical function upon discontinuation of treatment received in the core study and 2) evaluate the safety, tolerability, pharmacokinetics and efficacy of an additional 24 weeks of bimagrumab treatment in older patients with sarcopenia who previously received 24 weeks of treatment in the core study.

The parallel group, placebo-controlled randomized withdrawal design will allow an unbiased comparison of the duration of effect upon withdrawal from 3 different dose regimens of bimagrumab and placebo on changes in muscle quantity and patient physical function in a population of older adults with sarcopenia.

Detailed Summary: The primary objective is to assess the durability of effect of bimagrumab (BYM) by comparing withdrawal of BYM (i.e., BYM/placebo PBO switch) treatment with continued BYM administration every 4 weeks for 24 additional weeks of treatment (following participation in the core study) in older adults with sarcopenia as measured by change from week 25 to week 49 on the 6MWT. The secondary objectives are: - To evaluate the effect of BYM given intravenously every 4 weeks for 24 additional weeks of treatment (following completion of 24 weeks of treatment in the core study) on safety and tolerability as assessed by measures such as vital signs, clinical laboratory variables, electrocardiogram, echocardiogram, and adverse events as compared to treatment with PBO in older adults with sarcopenia. - To evaluate the durability of effect of BYM by comparing withdrawal of BYM (i.e. BYM/PBO switch) treatment with continued BYM administration every 4 weeks for 24 additional weeks of treatment (following completion of 24 weeks of treatment in the core study) in older adults with sarcopenia as measured by change from week 25 to week 49 on: - performance on the Short Physical Performance Battery score mobility as measured in gait speed (GS measured as a component of the SPPB) over 4 meters - total lean body mass and appendicular skeletal muscle index measured by dual energy X-ray absorptiometry
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: 6 minute walk test [ Time Frame: Week 25, Week 49 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number of participants with adverse events as a measure of Safety and Tolerability [ Time Frame: Weeks 25, 29, 37, 45, 49, 53 ]
• Short Physical Performance Battery [ Time Frame: Weeks 33, 41, 49 ]
  Change from Week 25 to Week 49
• Gait speed [ Time Frame: Weeks 33, 41, 49 ]
  Change from Week 25 to Week 49
• Total lean body mass and appendicular skeletal muscle index measured by DXA [ Time Frame: Weeks 37, 49 ]
  Change from Week 25 to Week 49

Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: April 30, 2015
Date Started: May 2015
Date Completion: February 2018
Last Updated: September 1, 2016
Last Verified: September 2016