A Phase 2 Randomized Controlled Study of Tralokinumab in Subjects with Idiopathic Pulmonary Fibrosis
| العنوان: | A Phase 2 Randomized Controlled Study of Tralokinumab in Subjects with Idiopathic Pulmonary Fibrosis |
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| المؤلفون: | Joseph M. Parker, Kevin R. Flaherty, Jon P. Fiening, Dewei She, Stephanie L. Roseti, Chris Kell, Ethan Grant, Tarik Haddad, Ian Glaspole, Lisa Lancaster |
| المصدر: | American Journal of Respiratory and Critical Care Medicine. 197:94-103 |
| بيانات النشر: | American Thoracic Society, 2018. |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | 0301 basic medicine, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Maximum Tolerated Dose, Population, Critical Care and Intensive Care Medicine, Placebo, Risk Assessment, Severity of Illness Index, Drug Administration Schedule, law.invention, 03 medical and health sciences, Idiopathic pulmonary fibrosis, FEV1/FVC ratio, 0302 clinical medicine, Double-Blind Method, Randomized controlled trial, law, Internal medicine, medicine, Clinical endpoint, Humans, education, Aged, education.field_of_study, Dose-Response Relationship, Drug, business.industry, Antibodies, Monoclonal, Middle Aged, Prognosis, medicine.disease, Interim analysis, Idiopathic Pulmonary Fibrosis, Survival Rate, Treatment Outcome, 030104 developmental biology, 030228 respiratory system, Immunology, Patient Safety, business, Cell Adhesion Molecules, Biomarkers, Tralokinumab |
| الوصف: | IL-13 is a potential therapeutic target for idiopathic pulmonary fibrosis (IPF); preclinical data suggest a role in tissue fibrosis, and expression is increased in subjects with rapidly progressing disease.Investigate efficacy and safety of tralokinumab, a human anti-IL-13 monoclonal antibody, in subjects with mild to moderate IPF.Subjects received tralokinumab (400 or 800 mg), or placebo, intravenously every 4 weeks for 68 weeks. The primary endpoint was change from baseline to Week 52 in percent predicted FVC in the intention-to-treat population. Exploratory analyses included assessment of clinical response in subgroups with baseline serum periostin concentration above/below median.The study was stopped due to lack of efficacy after interim analysis. Neither tralokinumab 400 mg nor tralokinumab 800 mg met the primary endpoint; least-squares mean difference (95% confidence interval) percent predicted FVC from baseline to Week 52: -1.77 (-4.13 to 0.59) (P = 0.140) and -1.41 (-3.73 to 0.91) (P = 0.234), respectively. The primary endpoint was also not met in either treatment group in subgroups defined by periostin baseline concentration. The percentage of subjects with decline in percent predicted FVC greater than or equal to 10% at Week 52 was numerically greater for tralokinumab-treated subjects compared with placebo. The most common treatment-emergent adverse events for tralokinumab 400 mg, tralokinumab 800 mg, and placebo were cough (17.5, 30.5, 22.8%), IPF progression and exacerbation (21.1, 16.9, 22.8%), and upper respiratory tract infection (17.5, 20.3, 12.3%), respectively.Tralokinumab demonstrated an acceptable safety and tolerability profile but did not achieve key efficacy endpoints. Clinical trial registered with www.clinicaltrials.gov (NCT01629667). |
| تدمد: | 1535-4970 1073-449X |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cf536d6dcf5827b482582e9cc4012eefTest https://doi.org/10.1164/rccm.201704-0784ocTest |
| رقم الانضمام: | edsair.doi.dedup.....cf536d6dcf5827b482582e9cc4012eef |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15354970 1073449X |
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