Safety, Tolerability, and Pharmacokinetics of Andecaliximab in Adults With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT02077465

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-11
• Study Completion Date: 2014-10-27

Brief Summary

The primary objective of the study is to assess the safety and tolerability of multiple infusions of andecaliximab (formerly GS-5745) in participants with chronic obstructive pulmonary disease (COPD) as assessed by adverse events (AEs) and laboratory abnormalities.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

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

Study Groups

Andecaliximab

Participants will receive andecaliximab every 2 weeks for a total of 3 infusions.

Group Type: EXPERIMENTAL

Andecaliximab

Intervention Type: DRUG

400 mg andecaliximab administered intravenously

Placebo to match andecaliximab

Participants will receive placebo to match andecaliximab every 2 weeks for a total of 3 infusions.

Group Type: PLACEBO_COMPARATOR

Placebo to match Andecaliximab

Intervention Type: DRUG

Placebo to match andecaliximab administered intravenously

Interventions

Andecaliximab

400 mg andecaliximab administered intravenously

Intervention Type: DRUG

Placebo to match Andecaliximab

Placebo to match andecaliximab administered intravenously

Intervention Type: DRUG

Other Intervention Names

GS-5745

Eligibility Criteria

Inclusion Criteria

• Weight: ≥ 45 kg to < 120 kg at screening
• Males or non-pregnant, non-lactating females
• Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception. Male individuals must refrain from sperm donation for 90 days post last infusion of the study drug
• Diagnosis of COPD per Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for at least 6 months prior to screening and anticipated to remain on stable therapy for the duration of the study
• Post-bronchodilator forced expiratory volume in one second (FEV1) ≥ 40% predicted
• No changes in COPD medications within 30 days prior to randomization
• Hepatic panel [aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, lactate dehydrogenase (LDH)] ≤ 2 times the upper limit of the normal range (ULN)
• Serum creatinine ≤ 2.0
• Hemoglobin ≥ 8.5 g/dL (both males and females)
• Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500 mm^3)
• Platelets ≥ 100 x 10^9/L

Exclusion Criteria

• Clinically significant active infection as judged by the investigator during screening
• Known history of HIV, hepatitis B or C during screening. Individuals who are hepatitis B surface antigen positive, but who received a successful series of hepatitis B vaccinations and never had the disease remain eligible
• A positive QuantiFERON-TB GOLD test during screening
• History of malignancy within the last 5 years except for patients who have been treated locally for non-melanoma skin cancer or cervical carcinoma in situ
• Any serious cardiac event such as myocardial infarction, unstable or life-threatening arrhythmia, hospitalization for cardiac failure within 6 months prior to randomization or any significant or new electrocardiogram (ECG) finding at Visit 1 as judged by the Investigator
• A hospitalization for a respiratory event such as, but not limited to, COPD, pneumonia, bronchiolitis, within the previous 6 months prior to randomization
• Chronic lung disease other than COPD such as: asthma, cystic fibrosis or fibrotic disease, α-1-antitrypsin deficiency, interstitial lung disease, pulmonary thromboembolic disease, or bronchiectasis
• Chronic use of systemic corticosteroids and/or treatment with systemic corticosteroids for an acute exacerbation of COPD (AECOPD) event, or other medical condition not requiring hospitalization, within 90 days of randomization.
• Treatment with antibiotics for an AECOPD event, or other medical condition not requiring hospitalization within 90 days of randomization, or any minor medical event not requiring hospitalization within 14 days of randomization.
• Treatment with any marketed or investigational biologic within 5 half-lives of the molecule or if unknown within 90 days of screening
• Individuals currently on nonbiologic immune modulator medications such as: azathioprine, cyclosporine, hydroxychloroquine, leflunomide, methotrexate, mycophenolate mofetil, sulfasalazine, tofacitinib, within 90 days of randomization

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Advanced Pharma CR, LLC

Miami, Florida, United States

Elite Research Institute

Miami, Florida, United States

Compass Research, LLC

Orlando, Florida, United States

University at Buffalo CTRC

Buffalo, New York, United States

Volunteer Research Group

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

GS-US-368-1212

Identifier Type: -

Identifier Source: org_study_id