Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study
Primary Objective:
To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691).
Secondary Objectives:
To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study.
To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to:
A screening period, up to 3 weeks, applied only for participants who came from DRI12544 study. The total study duration, per participant, was a maximum of 108 weeks (or 111 weeks considering a maximum screening period of 3 weeks for study DRI12544) for the participants enrolled prior to Amendment 04 approval and a maximum of 60 weeks for the participants enrolled after Amendment 04 approval.
Following amendment 04 (dated 31 Oct 2016) the open-label treatment duration was amended to 48 weeks (1 year); and the 16-week post-treatment period was shortened to 12 weeks.
Inclusion criteria:
- Participants with asthma who completed the treatment period in a previous dupilumab asthma clinical study (i.e., PDY14192, EFC13579 or EFC13691) or participants with asthma who completed the treatment and follow-up periods in previous dupilumab asthma Study DRI12544.
Exclusion criteria:
- Participants who experienced any hypersensitivity reactions to Investigational Medicinal Product (IMP) in the previous dupilumab asthma study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab, may present an unreasonable risk for the participant.
The above information was not intended to contain all considerations relevant to a Participant's potential participation in a clinical trial.
Caba, 1120, Argentina
Caba, C1414AIF, Argentina
Caba, C1425BEN, Argentina
Caba, C1425FVH, Argentina
Caba, C1426ABP, Argentina
Capital Federal, C1425DUC, Argentina
Rüdersdorf Bei Berlin, 15562, Germany
Gödöllö, 2100, Hungary
Akashi-Shi, Japan
Asahi-Shi, Japan
Chiyoda-Ku, Japan
Edogawa-Ku, Japan
Fukuyama-Shi, Japan
Habikino-Shi, Japan
Himeji-Shi, Japan
Hirakata-Shi, Japan
Iizuka-Shi, Japan
Isesaki-Shi, Japan
Kasuga-Shi, Japan
Kishiwada-Shi, Japan
Kodaira-Shi, Japan
Kokubunji-Shi, Japan
Koushi-Shi, Japan
Kurashiki-Shi, Japan
Machida-Shi, Japan
Mizunami-Shi, Japan
Muroran-Shi, Japan
Naka-Gun, Japan
Naruto-Shi, Japan
Obihiro-Shi, Japan
Ome-Shi, Japan
Osaka Sayama-Shi, Japan
Osaka Sayama-Shi, Japan
Osaki-Shi, Japan
Ota-Shi, Japan
Sagamihara-Shi, Japan
Sakaide-Shi, Japan
Setagaya-Ku, Japan
Seto-Shi, Japan
Shibuya-Ku, Japan
Shinagawa-Ku, Japan
Shinjuku-Ku, Japan
Sumida-Ku, Japan
Tachikawa-Shi, Japan
Tachikawa-Shi, Japan
Tomakomai-Shi, Japan
Uozu-Shi, Japan
Urasoe-Shi, Japan