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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01669174
First received: March 1, 2012
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD) With Cachexia
Drug: Placebo
Drug: BYM338
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized, Double Blind, Placebo Controlled, Multi-centre Study to Asses the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of BYM338 in Chronic Obstructive Pulmonary Disease Patients With Cachexia

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in thigh muscle volume compare to placebo as measured by MRI [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in 6 minute walk distance compared to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability of BYM338 in COPD patients with cachexia [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic profile and immunogenicity response to BYM338 in COPD patients with cachexia [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number of participants with adverse events as a measure of safety and tolerability of BYM338 in COPD patients with cachexia [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BYM338 Drug: BYM338
BYM338
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669174

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, California
Novartis Investigative Site Recruiting
Torrance, California, United States, 90502
United States, Connecticut
Novartis Investigative Site Withdrawn
Waterbury, Connecticut, United States, 06708
United States, Georgia
Novartis Investigative Site Terminated
Savannah, Georgia, United States, 31419
United States, Illinois
Novartis Investigative Site Recruiting
Normal, Illinois, United States, 61761
United States, Montana
Novartis Investigative Site Recruiting
Missoula, Montana, United States, 59808
United States, Ohio
Novartis Investigative Site Not yet recruiting
Cincinnati, Ohio, United States, 452242
Novartis Investigative Site Not yet recruiting
Columbus, Ohio, United States, 43213
United States, South Carolina
Novartis Investigative Site Recruiting
Spartanburg, South Carolina, United States, 29303
Netherlands
Novartis Investigative Site Recruiting
Maastricht, Netherlands, 6211
Romania
Novartis Investigative Site Withdrawn
Bucharest, Romania, Sector 5
United Kingdom
Novartis Investigative Site Not yet recruiting
Leicester, United Kingdom, LE1 5WW
Novartis Investigative Site Recruiting
London, United Kingdom, SW 6NP
Novartis Investigative Site Recruiting
Machester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01669174     History of Changes
Other Study ID Numbers: CBYM338X2204, 2011-000461-12
Study First Received: March 1, 2012
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Novartis:
Chronic Obstructive Pulmonary Disease
COPD; cachexia; muscle wasting

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cachexia
Respiratory Tract Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014