ong-Term Safety Evaluation of dupilumab in patients with asthma

Phase 1

• Conditions: Asthma; MedDRA version: 16.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-003856-19-ES
• Lead Sponsor: Sanofi-aventis recherche et développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-21
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 560

Inclusion Criteria

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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified