Phase 2
N=42
Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02573233 ↗Enrolled (actual)
42
Serious AEs
2.4%
Results posted
Jan 2019
Primary outcome: Primary: Change From Baseline in Eosinophils Cells Count in the Bronchial Submucosa at Week 12 — 5.80; -6.04 cells/mm^2 — p=0.8400
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Dupilumab SAR231893/REGN668 (Drug); fluticasone propionate and salmeterol (Drug); budesonide and formoterol (Drug); mometasone furoate and formoterol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Eosinophils Cells Count in the Bronchial Submucosa at Week 12 |
5.80; -6.04 | 0.8400 |
| PRIMARY Change From Baseline in Mucin-Stained Area in the Bronchial Submucosa at Week 12 |
64.09; -142.74 | 0.0336 sig |
| PRIMARY Change From Baseline in Mast Cells Count (Chymase Positive) in the Bronchial Submucosa at Week 12 |
-14.80; 1.76 | 0.4795 |
| PRIMARY Change From Baseline in Mast Cells Count (Tryptase Positive) in the Bronchial Submucosa at Week 12 |
2.37; -20.89 | 0.4494 |
| PRIMARY Change From Baseline in T-Lymphocytes Count in the Bronchial Submucosa at Week 12 |
-36.70; 34.21 | 0.6865 |
| PRIMARY Change From Baseline in T-Helper Lymphocytes Count in the Bronchial Submucosa at Week 12 |
7.26; 62.34 | 0.7588 |
| SECONDARY Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 12 |
3.9; -15.1 | 0.0012 sig |
| SECONDARY Average Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 6 Through Week 12 |
3.5; -16.0 | 0.0005 sig |
| SECONDARY Number of Participants With Antidrug Antibodies (ADA) |
1; 0; 0; 1; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK) Assessment: Serum Functional Dupilumab Concentration |
0.00; 52675.00; 59969.00; 61097.95; 67387.00; 20728.17 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
17; 15; 0; 1; 0; 0 | — |
Summary
Primary Objective:
To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in participants with persistent asthma.
Secondary Objective:
To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.
Eligibility Criteria
Inclusion criteria
- Male and female adults with a physician diagnosis of persistent asthma for ≥12 months.
- Existing treatment with medium to high dose inhaled corticosteroids in combination with a long-acting beta agonist for at least 3 months with a stable dose ≥1 month prior to Visit 1 (Screening Visit).
- Treatment with a third asthma controller for at least 3 months with a stable dose >=1 month prior to Visit 1 was allowed.
- Pre-bronchodilator forced expiratory volume (FEV1) 55 to 85% of predicted normal.
Exclusion criteria
- Participants 65 years.
- Fractional exhaled nitric oxide (FeNO) 10 pack-years) or current smoker (within 6 months prior to Visit 1).
- Comorbid disease that might interfere with the evaluation of investigational medicinal product or conduct of study procedures (e.g., bronchoscopy).
- Anti-immunoglobulin E (IgE) therapy (omalizumab) or any other biologic therapy within 6 months of Visit 1.
- Exposure to another investigative study medication within a time period prior to Visit 1 that is less than 5 half-lives of the study medication.
- Treatment with systemic (oral or injectable) corticosteroids within 28 days of Visit 1.
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 (NCT02573233). 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.