Phase 2
N=776
An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01854047 ↗Enrolled (actual)
776
Serious AEs
7.0%
Results posted
Jun 2017
Primary outcome: Primary: Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population — 1.86; 1.77; 1.8; 1.87 liter — p=0.0063
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dupilumab (Drug); placebo (Drug); ICS/LABA therapy (Drug); Salbutamol/albuterol (Drug); Levosalbutamol/levalbuterol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population |
1.86; 1.77; 1.8; 1.87; 1.8; 2.13 | 0.0063 sig |
| PRIMARY Absolute Change From Baseline in FEV1 at Week 12: ITT Population |
1.82; 1.85; 1.79; 1.86; 1.88; 2.01 | 0.0002 sig |
| SECONDARY Percent Change From Baseline in FEV1 at Week 12: HEos-ITT Population |
10.07; 25.29; 27.42; 20.68; 18.07 | — |
| SECONDARY Percent Change From Baseline in FEV1 at Week 12: ITT Population |
7.04; 16.64; 19.15; 13.55; 13.04 | — |
| SECONDARY Annualized Event Rate of Severe Exacerbation During The Treatment Period: HEos-ITT Population |
1.044; 0.201; 0.30; 0.678; 0.358 | — |
| SECONDARY Annualized Event Rate of Severe Exacerbation During The Treatment Period: ITT Population |
0.897; 0.265; 0.269; 0.599; 0.415 | — |
| SECONDARY Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population |
0.21; 0.082; 0.082; 0.094; 0.052; 0.287 | — |
| SECONDARY Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: ITT Population |
0.207; 0.092; 0.07; 0.112; 0.075; 0.266 | — |
| SECONDARY Annualized Event Rate of Loss of Asthma Control (LOAC) During The Treatment Period: HEos-ITT Population |
1.312; 0.322; 0.446; 0.788; 0.424 | — |
| SECONDARY Annualized Event Rate of LOAC During The Treatment Period: ITT Population |
1.107; 0.326; 0.347; 0.73; 0.563 | — |
| SECONDARY Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: HEos-ITT Population |
0.30; 0.115; 0.113; 0.126; 0.052; 0.392 | — |
| SECONDARY Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: ITT Population |
0.258; 0.112; 0.09; 0.145; 0.096; 0.338 | — |
| SECONDARY Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-ITT Population |
1.15; 1.45; 1.22; 1.31; 1.18; 0.83 | — |
| SECONDARY Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population |
1.17; 1.25; 1.24; 1.33; 1.29; 0.90 | — |
| SECONDARY Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-ITT Population |
1.33; 1.72; 1.46; 1.52; 1.39; 0.95 | — |
| SECONDARY Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population |
1.32; 1.47; 1.42; 1.50; 1.47; 1.02 | — |
| SECONDARY Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-ITT Population |
2.55; 2.98; 2.65; 2.69; 2.76; 1.52 | — |
| SECONDARY Change From Baseline in ACQ-5 Score at Week 12: ITT Population |
2.69; 2.80; 2.73; 2.70; 2.78; 1.55 | — |
| SECONDARY Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-ITT Population |
4.16; 3.82; 4.02; 3.99; 3.89; 5.05 | — |
| SECONDARY Change From Baseline in AQLQ Global Score at Week 12: ITT Population |
4.12; 3.91; 4.03; 4.02; 4.00; 5.00 | — |
| SECONDARY Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: HEos-ITT Population |
2.53; 3.61; 3.02; 3.15; 2.42; 1.88 | — |
| SECONDARY Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: ITT Population |
2.72; 3.25; 2.98; 3.36; 3.01; 2.20 | — |
Summary
Primary Objective:
To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma.
Secondary Objective:
To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to:
* Safety and tolerability
* Dupilumab systemic exposure and anti-drug antibodies
Eligibility Criteria
Inclusion criteria
Participants with a physician diagnosis of moderate to severe, uncontrolled asthma for >=12 months, based on the Global Initiative for Asthma (GINA) 2009 Guidelines and:
- Existing treatment with moderate or high-dose inhaled corticosteroid / long-acting beta-2 agonist
- Forced expiratory volume (FEV1) 40 to 80% of predicted normal
- Asthma Control Questionnaire, 5-question version (ACQ-5) score >=1.5
- Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1)
- Had experienced, within prior year: hospitalization, emergency or urgent care visit or systemic corticosteroid treatment for worsening asthma
Exclusion criteria
- Participants 10 pack-years
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01854047). 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.