BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD) With Cachexia
• Interventions: Drug: Placebo; Drug: BYM338

• Registration Number: NCT01669174
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh muscle volume compared to placebo. The study will last for approximately 24 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-20
• Study Start: 2012-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2015-12-01
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-27
• Last Update Submitted: 2016-04-27
• Results First Posted: 2016-05-03
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BYM338	BYM338	-

Primary Outcome Measures

Name	Time	Method
Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24	Baseline, Weeks 4, 8, 16, 24	Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 4,8,16 and 24 was considered responders.

Secondary Outcome Measures

Name	Time	Method
Change in 6 Minute Walk Distance Compared to Placebo	Baseline, Weeks 4, 8, 16, 24	Practical simple test that requires a 100-ft hallway but no exercise quipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired patients. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD)
Maximum Observed Serum Concentration (Cmax)	0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose	The observed maximum plasma concentration following drug administration
Time to Reach the Maximum Concentration After Drug Administration (Tmax)	24 weeks	The time to reach the maximum concentration after drug administration
AUC0-56 and AUClast	0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose	AUC0-56, the area under the serum concentration-time curve from the time zero to the end of the dosing interval, day 56. AUC0-56 was analyzed for dose 1 and 2. AUClast is from time zero to the last quantifiable concentration. AUClast was analyzed for dose 2 only.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Machester, United Kingdom