Phase 3
Completed N=210
Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma
Source: ClinicalTrials.gov NCT02528214 ↗Enrolled (actual)
210
Serious AEs
7.1%
Results posted
Oct 2018
Primary outcomePrimary: Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control — 41.85; 70.09 Percentage reduction from baseline — p=< 0.0001
◆ Published Evidence
Highly cited
1,152citations · ~144 / year
Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma.
Summary
Primary Objective:
To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma.
Secondary Objectives:
* To evaluate the safety and tolerability of dupilumab.
* To evaluate the effect of dupilumab in improving participants-reported outcomes.
* To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies.
Linked Publications (5)
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Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma.
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Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis.
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Long-term efficacy of dupilumab in asthma with or without chronic rhinosinusitis and nasal polyps.
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The long-term effect of dupilumab on dyspnea, sleep, and activity in oral corticosteroid-dependent severe asthma.
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Are We Poised to Change the Trajectory of Maintenance Oral Corticosteroid Use in Severe Asthma in the Age of Biologics?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control |
41.85; 70.09 | < 0.0001 sig |
| PRIMARY Supplementary Presentation of Primary Outcome Measure Data: Median Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control |
50.0; 100.0 | — |
| SECONDARY Percentage of Participants Achieving >= 50% Reduction in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control |
53.3; 79.6 | < 0.0001 sig |
| SECONDARY Percentage of Participants Achieving a Reduction in Oral Corticosteroids Dose to <5 mg/Day at Week 24 While Maintaining Asthma Control |
37.4; 71.8 | < 0.0001 sig |
| SECONDARY Percentage of Participants Achieving Maximum Possible Reduction in Oral Corticosteroids Dose Per Protocol at Week 24 While Maintaining Asthma Control |
29.9; 52.4 | 0.0024 sig |
| SECONDARY Percentage of Participants Who No Longer Required Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control |
29.2; 52.4 | 0.0015 sig |
| SECONDARY Absolute Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control |
11.75; 10.75; 6.32; 3.13; 5.45; 7.66 | — |
Eligibility Criteria
Inclusion criteria
Adult and adolescent (12 years of age or older) participants with a physician diagnosis of asthma for >=12 months, based on the Global Initiative for Asthma (GINA) 2014 guidelines and the following criteria:
- Participants with severe asthma and a well-documented, regular prescribed treatment of maintenance corticosteroids in the 6 months prior to Visit 1 and using a stable OCS dose (ie, no change of OCS dose) for 4 weeks prior to Visit 1. Participants must be taking 5 to 35 mg/day of prednisone/prednisolone, or the equivalent, at Visit 1 and at the randomization visit. In addition, the participants must agree to switch to study-required prednisone/prednisolone as their OCS and use it per protocol for the duration of the study.
- Existing treatment with high-dose inhaled corticosteroid (ICS; >500 mcg total daily dose of fluticasone propionate or equivalent) in combination with a second controller (ie, long-acting beta agonist [LABA], leukotriene receptor antagonist [LTRA]) for at least 3 months with a stable dose of ICS for >=1 month prior to Visit 1. In addition, participants requiring a third controller for their asthma are considered eligible for this study, and it should also be used for at least 3 months with a stable dose >= 1 month prior to Visit 1.
- A forced expiratory volume in 1 second (FEV1) =18 years of age).
- Participants who weighed 10 pack-years.
- Comorbid disease that might interfere with the evaluation of the investigational medicinal product.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT02528214) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.