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

NCT ID: NCT01669174

Last Updated: 2016-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD) With Cachexia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

BYM338

Group Type: EXPERIMENTAL

BYM338

Intervention Type: DRUG

BYM338

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Placebo

Intervention Type: DRUG

BYM338

BYM338

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent must be obtained before any assessment is performed.
• Males and females ages 40 to 80 years
• Smoking history of at least 10 pack-years
• Diagnosis of COPD according to GOLD guidelines (GOLD, 2010), with a post-bronchodilator FEV¬1 < 80% predicted and FEV1/FVC ratio < 0.70
• BMI <20 kg/m2 or skeletal muscle mass index by DXA < 7.25 kg/m2 for men or <5.45 kg/m2 for women.
• In general stable health, including managed COPD, by past medical history, physical examination, vital signs at baseline as determined by the investigator.

Exclusion Criteria

• Patients with MRC dyspnoea grade 5 (i.e. patients too breathless to leave the house or breathless when dressing)
• Plans for lung transplantation or lung reduction surgery within four months of enrollment
• Patients participating in a formal pulmonary rehabilitation program within 3 months of dosing
• History of malignancy of any organ system (other than excised non-melanomatous carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• Diseases other than cancer known to cause cachexia or muscle atrophy, including but not limited to congestive heart failure of any stage, chronic kidney disease (estimated GFR < 30 mL/min using the MDRD equation), rheumatoid arthritis, primary myopathy, stroke, HIV infection, tuberculosis or other chronic infection, uncontrolled diabetes mellitus, etc.
• Inflammatory bowel disease, celiac disease, short bowel syndrome, pancreatic insufficiency
• Use of any prescription drugs known to affect muscle mass, including androgen supplements, anti-androgens (such as LHRH agonists), anti-estrogens (tamoxifen, etc.) recombinant human growth hormone (rhGH), insulin, oral beta agonists, megestrol acetate, dronabinol, metformin, etc.
• Hemoglobin concentration below 11.0 g/dL at screening.
• Liver disease or liver injury.
• Use of other investigational drugs at the time of enrollment, or within 30 days and for any other limitation of participation in an investigational trial based on local regulations.
• Women of child-bearing potential.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Torrance, California, United States

Novartis Investigative Site

Savannah, Georgia, United States

Novartis Investigative Site

Normal, Illinois, United States

Novartis Investigative Site

Missoula, Montana, United States

Novartis Investigative Site

Spartanburg, South Carolina, United States

Novartis Investigative Site

Maastricht, , Netherlands

Novartis Investigative Site

Leicester, , United Kingdom

Novartis Investigative Site

London, , United Kingdom

Novartis Investigative Site

Machester, , United Kingdom

Countries

United States; Netherlands; United Kingdom

References

Polkey MI, Praestgaard J, Berwick A, Franssen FME, Singh D, Steiner MC, Casaburi R, Tillmann HC, Lach-Trifilieff E, Roubenoff R, Rooks DS. Activin Type II Receptor Blockade for Treatment of Muscle Depletion in Chronic Obstructive Pulmonary Disease. A Randomized Trial. Am J Respir Crit Care Med. 2019 Feb 1;199(3):313-320. doi: 10.1164/rccm.201802-0286OC.

Reference Type: DERIVED

PMID: 30095981 (View on PubMed)

Other Identifiers

2011-000461-12

Identifier Type: -

Identifier Source: secondary_id

CBYM338X2204

Identifier Type: -

Identifier Source: org_study_id