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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01669174
Recruitment Status : Completed
First Posted : August 20, 2012
Results First Posted : May 3, 2016
Last Update Posted : May 3, 2016
Information provided by (Responsible Party):
Novartis ( 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: BYM338 Drug: BYM338

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24 [ Time Frame: 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 :
  1. Change in 6 Minute Walk Distance Compared to Placebo [ Time Frame: 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)

  2. Maximum Observed Serum Concentration (Cmax) [ Time Frame: 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

  3. Time to Reach the Maximum Concentration After Drug Administration (Tmax) [ Time Frame: 24 weeks ]
    The time to reach the maximum concentration after drug administration

  4. AUC0-56 and AUClast [ Time Frame: 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.

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01669174

United States, California
Novartis Investigative Site
Torrance, California, United States, 90502
United States, Georgia
Novartis Investigative Site
Savannah, Georgia, United States, 31419
United States, Illinois
Novartis Investigative Site
Normal, Illinois, United States, 61761
United States, Montana
Novartis Investigative Site
Missoula, Montana, United States, 59808
United States, South Carolina
Novartis Investigative Site
Spartanburg, South Carolina, United States, 29303
Novartis Investigative Site
Maastricht, Netherlands, 6211
United Kingdom
Novartis Investigative Site
Leicester, United Kingdom, LE1 5WW
Novartis Investigative Site
London, United Kingdom, SW 6NP
Novartis Investigative Site
Machester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01669174     History of Changes
Other Study ID Numbers: CBYM338X2204
First Posted: August 20, 2012    Key Record Dates
Results First Posted: May 3, 2016
Last Update Posted: May 3, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Wasting Syndrome
Respiratory Tract Diseases
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Antibodies, Monoclonal
Antibodies, Blocking
Immunologic Factors
Physiological Effects of Drugs