Overview

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

Status:
Completed
Trial end date:
2018-12-03
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Antibodies, Blocking
Antibodies, Monoclonal
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)