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

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ClinicalTrials.gov 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 )

March 1, 2012
August 20, 2012
December 1, 2015
May 3, 2016
May 3, 2016
September 2012
December 2014   (Final data collection date for primary outcome measure)
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.
Change in thigh muscle volume compare to placebo as measured by MRI [ Time Frame: 4, 8, 16 and 24 weeks ]
Complete list of historical versions of study NCT01669174 on ClinicalTrials.gov Archive Site
  • 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)
  • 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
  • Time to Reach the Maximum Concentration After Drug Administration (Tmax) [ Time Frame: 24 weeks ]
    The time to reach the maximum concentration after drug administration
  • 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.
  • Change in 6 minute walk distance compared to placebo [ Time Frame: 4, 8, 12, 16 and 24 weeks ]
  • Number of Participants with Adverse Events as a Measure of Safety and tolerability of 30 mg/kg of BYM338 in COPD patients with cachexia [ Time Frame: 24 weeks ]
  • Pharmacokinetic profile and immunogenicity response to a single 30 mg/kg infusion of BYM338 in COPD patients with cachexia [ Time Frame: 24 weeks ]
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BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia
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
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Chronic Obstructive Pulmonary Disease (COPD) With Cachexia
  • Drug: Placebo
  • Drug: BYM338
  • Experimental: BYM338
    Intervention: Drug: BYM338
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2014
December 2014   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United Kingdom,   United States
Not Provided
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP