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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Andecaliximab; Drug: Placebo to match Andecaliximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02077465

GS-US-368-1212

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

11 participants in 2 patient groups, including a placebo group

Andecaliximab

Experimental group

Description:

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

Treatment:

Drug: Andecaliximab

Placebo to match andecaliximab

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo to match Andecaliximab