Clinical Trials List
2017-04-01 - 2020-06-01
Phase III
Terminated3
ICD-10J45.998
Other asthma
ICD-10J45
Asthma
Open-label extension study to evaluate the long-term safety and tolerability of dupilumab inpatients with asthma who participated in a previous dupilumab asthma clinical study
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Trial Applicant
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Sponsor
Sanofi
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chih-Yen Tu Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Wen-Te Liu Division of Thoracic Medicine
- Po-Hao Feng Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
4 Terminated
Audit
CRO
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
1 Terminated
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• The number (n) and percentage (%) of patients experiencing any
treatment-emergent adverse events (TEAEs).
Secondary endpoint(s)
• Safety and Tolerability
- Vital signs
- Physical examination
- Electrocardiogram (ECG)
- Clinical laboratory tests
• Efficacy
Forced expiratory volume in 1 second (FEV1).
- Asthma Control Questionnaire – 5 question version (ACQ-5).
- Severe asthma exacerbation events, during the treatment period.
- Asthma Quality of Life Questionnaire - Standardized [AQLQ(S)].
- EuroQol 5 dimensions questionnaire, 3-level version (EQ-5D-3L).
- Health care resource utilization questionnaire.
- Morning and evening peak expiratory flow (PEF).
- Asthma symptom scores.
- Number of inhalations/day of salbutamol/albuterol or levosalbutamol/levalbuterol for
symptom relief.
- Nocturnal awakenings due to asthma requiring use of reliever medication.
- Prescribed OCS dose for patients from the EFC13691 study.
• Dupilumab systemic exposure and anti-drug antibodies
- Serum dupilumab concentrations
- Anti-drug antibodies (ADA)
• Biomarkers
- Blood: eosinophil count
- Serum: immunoglobulin, total IgE
Inclution Criteria
Eligible patients who have completed the treatment period in a previous dupilumab asthma study (ie, PDY14192, EFC13579, or EFC13691) or
patients with asthma who completed the treatment and follow-up periods in previous dupilumab asthma study DRI12544 may be enrolled in the LTS12551 study.
Exclusion Criteria
EFC13691 studies
• Patients who have experienced hypersensitivity reactions to dupilumab which, in the opinion of the investigator, could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient
• Patients diagnosed with active parasitic infection; suspected or at high risk of parasitic infection, unless clinical and/or laboratory
assessments before enrollment have ruled out an active infection
• 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 perinvestigator 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.
• For patients from DRI12544 study, drug induced liver injury
related criteria at Screening:
- Underlying clinically significant hepatobiliary disease OR
- Alanine Aminotransferase (ALT) >3 Upper Limit of Normal
(ULN).
• For patients from DRI12544 study, abnormal lab values at Screening:
- Creatine phosphokinase (CPK) >10 ULN OR
- Platelets <100.000 cells/mm3 OR
- Eosinophils >1500 cells/mm3
The Estimated Number of Participants
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Taiwan
8 participants
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Global
2082 participants
