Open label extension study to evaluate the long-term safety and tolerability of dupilumab in patients with asthma who participated in previous dupilumab asthma clinical study

Sanofi-aventis recherche et développement0 个研究点目标入组 560 人开始时间: 2014年3月21日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•Eligible patients who have completed a previous dupilumab asthma study (ie, DRI12544)
•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 549
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 11

•- Patients who did not complete the previous dupilumab asthma study (entire study duration)
•- Patients who have experienced hypersensitivity reactions to dupilumab
•- Patients diagnosed with active parasitic infection; suspected or at high risk of parasitic infection, unless clinical and/or laboratoryassessments before randomization have ruled out an activeinfection
•- Medical history of human immunodeficiency virus (HIV) infection
•- Known or suspected medical history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution; or unusually frequent, recurrent or prolonged infections, as per investigator judgment
•- Evidence of acute or chronic infection requiring treatment with antibacterials, antivirals, antifungals, antiparasitics or antiprotozoals within 4 weeks before Visit 1; significant viral infections within 4 weeks before Visit 1 that may not have received antiviral treatment (eg, influenza receiving only symptomatic treatment)
•- Patients with any event or laboratory abnormality that, as per investigator judgment, would adversely affect participation of the patient in this study.
•- Patients who have traveled to parasitic endemic area within 6 months prior to screening.

发起方