|Title:||A Randomized, Placebo-Controlled Phase 2 Trial of CNTO 6785 in Chronic Obstructive Pulmonary Disease||Authors:||Eich A.
|Issue Date:||2017||Publisher:||Taylor and Francis Ltd||Journal Volume:||14||Journal Issue:||5||Start page/Pages:||476-483||Source:||COPD: Journal of Chronic Obstructive Pulmonary Disease||Abstract:||
Interleukin (IL)-17A may be an underlying factor in the pathophysiology of chronic obstructive pulmonary disease (COPD). Anti-IL-17 monoclonal antibodies have been used successfully in treating several immune-mediated inflammatory diseases. This phase 2, randomized, placebo-controlled, double-blind, parallel-group, proof-of-concept study is the first clinical study evaluating the efficacy and safety of the anti-IL-17A monoclonal antibody CNTO 6785 in patients with symptomatic moderate-to-severe COPD. Patients were treated with CNTO 6785 (n = 93) or placebo (n = 94) intravenously at Weeks 0, 2, and 4 (induction), then Weeks 8 and 12, and followed till Week 24. The primary efficacy endpoint was the change from baseline in pre-bronchodilator percent-predicted forced expiratory volume in 1?second at Week?16. Samples were collected at all visits for pharmacokinetic (PK) evaluation, and standard safety assessments were performed. The mean difference in the primary efficacy endpoint between CNTO 6785 and placebo was not statistically significant (?0.49%; p = 0.599). No other efficacy endpoints demonstrated clinically or statistically significant differences with CNTO 6785 compared with placebo. CNTO 6785 was generally well tolerated; no major safety signals were detected. The most frequently reported treatment-emergent adverse events were infections and infestations; however, no notable differences were observed between CNTO 6785 and placebo in terms of rates of infections. PK results suggested that the steady state of serum CNTO 6785 concentration was reached within 16?weeks. These results suggest that IL-17A is unlikely to be a dominant driver in the pathology of, or a viable therapeutic target for, COPD. ClinicalTrials.gov Identifier: NCT01966549; EudraCT Identifier: 2012-003607-36. ? 2017 The Author(s). Published with license by Taylor & Francis Group, LLC ? 2017, ? Andreas Eich, Veronika Urban, Marek Jutel, Jiri Vlcek, Jae Jeong Shim, Vasiliy I. Trofimov, Chong-Kin Liam, Ping-Hung Kuo, Yanyan Hou, Jun Xiao, Patrick Branigan and Christopher D. O'Brien.
|ISSN:||1541-2555||DOI:||10.1080/15412555.2017.1335697||SDG/Keyword:||antibiotic agent; antifungal agent; antivirus agent; beta 2 adrenergic receptor stimulating agent; bronchodilating agent; corticosteroid; drug antibody; immunoglobulin G1 antibody; interleukin 17 antibody; long acting drug; monoclonal antibody; monoclonal antibody CNTO 6785; muscarinic receptor blocking agent; placebo; unclassified drug; IL17A protein, human; interleukin 17; monoclonal antibody; adult; aged; ankle arthritis; anti-infective therapy; antibiotic therapy; antibody titer; antifungal therapy; antiviral therapy; Article; bacterial arthritis; chronic obstructive lung disease; concentration at steady-state; controlled study; disease exacerbation; disease severity; double blind procedure; drug blood level; drug efficacy; drug safety; drug tolerability; drug withdrawal; female; forced expiratory volume; herpes simplex; human; immunogenicity; infestation; leukocyte count; major clinical study; male; mediastinum disease; neutropenia; oropharynx candidiasis; osteomyelitis; parallel design; phase 2 clinical trial; pneumonia; priority journal; randomized controlled trial; respiratory tract disease; rhinopharyngitis; sepsis; thorax disease; thrush; urinary tract infection; viral skin disease; antagonists and inhibitors; chronic obstructive lung disease; clinical trial; middle aged; pathophysiology; proof of concept; Adult; Aged; Antibodies, Monoclonal; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Interleukin-17; Male; Middle Aged; Proof of Concept Study; Pulmonary Disease, Chronic Obstructive
|Appears in Collections:||醫學系|
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