A Phase 2b, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SUN11031 for Injection Administered Subcutaneously Twice Daily for 12 Weeks to Subjects Having Cachexia Associated with Chronic Obstructive Pulmonary Disease

• Conditions: Cachexia associated with chronic obstructive pulmonary disease

• Registration Number: EUCTR2007-007725-46-BG
• Lead Sponsor: Asubio Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

1. Male or non-pregnant female subjects =50 years of age with a clinical diagnosis of COPD for =12 months
2. A distance walked of =100 but =450 meters during the 6MWT performed at Screening
3. A clinical diagnosis of COPD based on a forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio of <70%, and an FEV1 of 20% to 79% predicted
4. COPD that has been stable, meaning that any reduction in FEV1 should be less than 10% between Screening and Baseline (Days -6 to -3), and that symptoms of COPD and concomitant medication use are stable, in the opinion of the Investigator
5. Chest x-ray within the past year that is compatible with COPD
6. Current or previous smokers, with a cumulative smoking history of at least 10 pack-years or exposure to indoor air pollution from biomass cooking and heating
7. Documented involuntary nonedematous weight loss >5% of subject’s usual body weight over the past 12 months or body mass index (BMI) =21 kg/m2 for males or BMI =20 kg/m2 for females (Prescott et al. Eur Respir J. 2002 Sep;20(3):539-44; Celli et al. N Engl J Med. 2004 Mar 4;350(10):1005-12).
8. Female subjects who are clinically sterile (eg, either postmenopausal or have undergone a tubal ligation or hysterectomy), or are practicing a medically acceptable method of birth control (eg, oral, transdermal, implantable, or injectable contraceptive medications; double-barrier method or intrauterine device [IUD])
9. Capable of understanding and complying with the requirements of the study and willing to sign the informed consent form. (If required by the relevant ethical, legal, or regulatory authorities, a Health Insurance Portability and Accountability Act of 1996 [HIPAA] and/or other privacy consent must also be signed.)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. A BMI >26 kg/m2
2. Use, over a total of 7 or more days, of parenteral corticosteroids at a dose equivalent to prednisone at =5 mg/day or oral corticosteroids at a dose equivalent to prednisone at >10 mg/day within the 2 months before Screening; however, subjects will be allowed to participate if on stable doses equivalent to prednisone at =10 mg/day for at least 2 months before Screening, and are planning to remain on the same stable dose throughout thestudy.
3. Plan to participate in a pulmonary rehabilitation program during the study
4. Weight loss that is considered to be, in the opinion of the Investigator, the result of food deprivation
5. Unintended weight loss that may be due to disease other than COPD
6. Unable or unwilling to be trained to self-administer the study drug by subcutaneous injection twice daily, and for whom arrangements cannot be made for a third party to reliably administer the injections
7. Severe anemia (hemoglobin =8 g/dL)
8. COPD exacerbation defined as a Type 1 or 2 exacerbation according to the Winnipeg criteria (see Appendix 19), acute infection, or prolonged fever within 4 weeks before Screening
9. Currently undergoing treatment or evaluation for cancer, or has a history of treatment for cancer within the past 3 years, exception being nonmelanoma skin cancer (basal cell or squamous cell carcinoma of the skin) and carcinoma in situ of the cervix
10. Type I or type II diabetes mellitus or a fasting serum glucose of =115 mg/dL (6.4 mmol/L) (fasting is overnight)
11. Serious disease or conditions that would interfere with the subject's ability to complete the functional measures included in this protocol; or any illness that, in the opinion of the Investigator, might interfere with the results of the study or the subject’s ability to participate
12. Pulmonary embolism, deep venous thrombosis, or clinically significant primary pulmonary hypertension within the past 6 months
13. Significant ischemic heart disease or chronic heart failure (New York Heart Association [NYHA] Class IV cardiac disease)
14. Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >110 mmHg)
15. A history of symptomatic orthostatic hypotension or syncope; or orthostatic hypotension on Screening or Baseline (Days -6 to -3) (orthostatic hypotension is defined as a decrease in systolic blood pressure by =20 mmHg measured after 2 minutes in a standing position compared with the systolic blood pressure measured after 10 minutes in a supine position)
16. Evidence of ascites, pleural effusion, or lower extremity edema
17. Severe vitamin D deficiency (25-hydroxyvitamin D <10 ng/mL)
18. Known mechanical obstruction of the alimentary tract and/or malabsorption
19. Dental or swallowing problems that may have a negative effect on food intake
20. Serum creatinine >2.5 mg/dL; or alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma-glutamyltransferase (GGT) >3 times the upper limit of normal (ULN), or bilirubin >2.5 mg/dL
21. A diagnosis of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
22. Use of any prescription drugs and non-prescription drugs/herbs that cause weight loss or affect appetite and absorption or that may cause nausea; or the use of appetite-promoting or anabolic medications within 15 days before Screening
23. A history of alcohol or drug abuse that, in the opinion of the Investigator, would interfere with the subject’s ability to comp

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified