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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

- Patients with asthma who completed the treatment period in a previous dupilumab asthma clinical study (ie, PDY14192, EFC13579 or EFC13691) or patients with asthma who completed the treatment and follow-up periods in pervious dupilumab asthma study DRI12544
- Patient is on a stable background dose of moderate or high dose inhaled ICS [(fluticasone propionate greater than 250 *g twice daily (or equipotent)] for ><= 1 month prior to V1 )
- Signed written informed consent

Exclusion Criteria

** Exclusion criteria related to study methodology **
E 01. Patients who have not completed the treatment period in PDY14192, EFC13579, or EFC13691 studies or the treatment and follow up periods in DRI12544 study
E 02. Chronic obstructive pulmonary disease (COPD) or other lung diseases (e.g., emphysema,
idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) which impair pulmonary function tests
E 03. Current smoker (smoking history >10 pack-years) or previous smoker (within 6 months
prior to V1)
E 04. Clinically significant comorbidity/lung disease other than asthma
E 05. Alcohol abuse or drug abuse
E 06. Inability to follow the procedures of the study/noncompliance (eg, due to language problems or psychological disorders)
E 07. Reversal of sleep pattern (eg, night shift workers)
E 08. Patients requiring beta-adrenergic receptor blockers (beta blockers) for any reason
E 09. Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days prior to Visit 1; biologic therapy within 6 months prior to Visit 1 (not including parent dupilumab study)
E 10. Patient receiving concomitant treatment prohibited in the study (see Protocol section 8.8.1)
E 11. Exposure to another investigative antibody within a time period prior to Visit 1 that is less
than 5 half-lives of the antibody (if known). In case the half-life is not known, then the minimum interval since exposure to the prior investigative antibody is 6 months. The minimum interval since exposure to any other (non-antibody) investigative study medication is 30 days prior to Visit 1
E 12. Patient is Investigator or any Sub-Investigator, research assistant, pharmacist, study
coordinator, other staff or relative thereof directly involved in the conduct of the protocol
E 13. Concomitant severe disease;** Exclusion criteria related to the active comparator and/or mandatory background therapies **
E 14. Diseases for which the use of background therapies are contraindicated, e.g., ICS (active
and inactive pulmonary tuberculosis) or LABA
E 15. Treatment with drugs associated with clinically significant QTc interval prolongation/ Torsades de Pointes ventricular tachycardia;** Exclusion criteria related to the current knowledge of Sanofi compound **
E 16. Patients with any event or laboratory abnormality per investigator judgment, would adversely affect participation of the patient in this study
E 17. Pregnant or breastfeeding women
E 18. (A) Women of childbearing potential (pre-menopausal female biologically capable of becoming pregnant) who:
* Do not have a confirmed negative serum *-hCG test at Visit 1
* Who are not protected by acceptable forms of effective contraception during the study, including the 16-week follow-up period as stated in the Protocol
(B) Male participant with a female partner of childbearing potential not protected by
acceptable method(s) of birth control (as defined in the Protocol).
E 19. Diagnosed active parasitic infection; suspected or high risk of parasitic infection, unless
clinical and (if necessary) laboratory assessments have ruled out active infection before enrolment
E 20. History of human immunodeficiency virus (HIV) infection or positive HIV screen (Anti-HIV-1 and HIV-2 antibodies) at Visit 1
E 21. Known or suspected history of immunosuppression, including history of invasive opportunistic infections

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of participants with adverse events</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Assessment of safety parameters (laboratory data, ECG and vital signs) -<br /><br>clinically significant changes from baseline<br /><br>- FEV1 - clinically significant changes from baseline<br /><br>- Asthma control questionnaire - clinically significant changes from baseline<br /><br>- Asthma symptom scores - clinically significant from baseline<br /><br>- Asthma Quality of Life Questionnaire (AQLQS) - clinically significant from<br /><br>baseline<br /><br>- Anti-drug antibodies - changes from baseline<br /><br>- Biomarkers - changes from baseline</p><br>