AsthmaPhase 2EXPEDITIONNCT02573233
Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma
A Phase 2 study testing Dupilumab SAR231893/REGN668, fluticasone propionate and salmeterol and budesonide and formoterol in people with Asthma, run by Sanofi at 16 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Dupilumab SAR231893/REGN668, fluticasone propionate and salmeterol and budesonide and formoterol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 16 sitesin 6 countries
- Study dates
- 27 Jan 2016to 3 Jan 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants <18 years or >65 years.
- Fractional exhaled nitric oxide (FeNO) <26 parts per billion (ppb) at Visit 1 (Screening Visit).
- Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, eosinophilic granulomatosis with polyangiitis [Churg-Strauss Syndrome]) which could impair lung function.
- A participant who experienced an asthma exacerbation that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to Visit 1.
- A participant who had experienced an upper or lower respiratory tract infection within the 4 weeks prior to Visit 1.
- Evidence of lung disease(s) other than asthma.
Show all 12Show fewer
- Previous smoker (smoking history >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.
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
United States6 sites
Investigational Site Number 840401
Boston, Massachusetts, 02115
Investigational Site Number 840403
Denver, Colorado, 80206
Investigational Site Number 840028
Pittsburgh, Pennsylvania, 15213
Investigational Site Number 840002
St Louis, Missouri, 63110
Investigational Site Number 840402
Tucson, Arizona, 85724
Investigational Site Number 840404
Winston-Salem, North Carolina, 27157-1071
Germany3 sites
Investigational Site Number 276013
Frankfurt am Main, 60596
Investigational Site Number 276011
Großhansdorf, 22927
Investigational Site Number 276012
Hanover, 30625
Canada2 sites
Investigational Site Number 124012
Montreal, H2X 2P4
Investigational Site Number 124018
Sainte-Foy, G1V 4G5
Denmark2 sites
Investigational Site Number 208002
Hvidovre, 2650
Investigational Site Number 208001
København NV, 2400
United Kingdom2 sites
Investigational Site Number 826010
London, W2 1NY
Investigational Site Number 826009
Oxford, OX3 7LE
About this study
Official title: An Exploratory, Double-blind, Placebo-controlled Study of the Effects of Dupilumab on Airway Inflammation of Adults With Persistent Asthma
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.
Read the detailed description
The total study duration for each participant was between approximately 29 and maximum of 30 weeks, consisting of a screening period of 5 weeks and optional up to 7 additional days, a treatment period of 12 weeks, and a post-treatment period of 12 weeks.
Participants who completed the treatment period could be eligible to participate in an open-label extension study.
- Conditions
- Asthma
- Being tested
- Placebo, Dupilumab SAR231893/REGN668, fluticasone propionate and salmeterol, budesonide and formoterol, mometasone furoate and formoterol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Pharmaceutical form:solution Route of administration: subcutaneous
Dupilumab SAR231893/REGN668Drug
Pharmaceutical form:solution Route of administration: subcutaneous
fluticasone propionate and salmeterolDrug
Also called Advair
Pharmaceutical form:inhalation aerosol, inhalation powder Route of administration: inhaled
budesonide and formoterolDrug
Also called Symbicort
Pharmaceutical form:inhalation aerosol Route of administration: inhaled
mometasone furoate and formoterolDrug
Also called Dulera
Pharmaceutical form:inhalation aerosol Route of administration: inhaled
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (for dupilumab), 2 subcutaneous injections on Day 1 (Week 1) as a loading dose followed by a single injection q2w from Week 2 to Week 14, added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. Receives: Drug: Placebo; Drug: fluticasone propionate and salmeterol; Drug: budesonide and formoterol; Drug: mometasone furoate and formoterol |
| Dupilumab | Experimental | Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection q2w from Week 2 to Week 14, added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. Receives: Drug: Dupilumab SAR231893/REGN668; Drug: fluticasone propionate and salmeterol; Drug: budesonide and formoterol; Drug: mometasone furoate and formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Eosinophils Cells Count in the Bronchial Submucosa at Week 12
Inflammatory cells i.e. eosinophils were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.
Measured: Baseline, Week 12
Change From Baseline in Mucin-Stained Area in the Bronchial Submucosa at Week 12
Mucin was identified by staining with Alcian-blue periodic acid-Schiff and/or immunostaining for MUC5AC and then the mucin-positive area was measured and expressed per square millimeter.
Measured: Baseline, Week 12
Change From Baseline in Mast Cells Count (Chymase Positive) in the Bronchial Submucosa at Week 12
Inflammatory cells i.e. mast cells were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.
Measured: Baseline, Week 12
Change From Baseline in Mast Cells Count (Tryptase Positive) in the Bronchial Submucosa at Week 12
Inflammatory cells i.e. mast cells were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.
Measured: Baseline, Week 12
Change From Baseline in T-Lymphocytes Count in the Bronchial Submucosa at Week 12
T-Lymphocytes i.e. CD3 positive cells were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.
Measured: Baseline, Week 12
Change From Baseline in T-Helper Lymphocytes Count in the Bronchial Submucosa at Week 12
T-helper i.e. CD4 positive lymphocytes were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.
Measured: Baseline, Week 12
Secondary outcomes (5)
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 12
FeNO is a surrogate marker for airway inflammation. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 mL/second, and reported in ppb.
Measured: Baseline, Week 12
Average Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 6 Through Week 12
FeNO is a surrogate marker for airway inflammation. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 mL/s, and reported in ppb.
The average change in FeNO from baseline to Week 6 through Week 12 was calculated as follows: For each participant the change in FeNO from Baseline to Week 6, Week 8, Week 10 and Week 12 was calculated (value at Week X - value at baseline). Subsequently the weekly mean of these 4 "change from baseline" values was determined (Weeks 6, 8, 10 and 12). Using these weekly mean values the overall arithmetic mean and standard deviation of the average change in FeNO from baseline to Week 6 through Week 12 was calculated.
Measured: From Baseline to Week 6 through Week 12
Number of Participants With Antidrug Antibodies (ADA)
Anti-drug antibodies were detected using a validated immunoassay. Incidence of ADA were classified as following: 1) Pre-existing immunoreactivity - an ADA positive response in the assay at baseline with all post treatment ADA results negative or an ADA positive response at baseline with all post treatment ADA responses less than 4-fold over baseline titer levels. 2) Treatment-emergent ADA: an ADA positive response in the assay post first dose, when baseline results were negative or missing. 3) Treatment-boosted ADA: an ADA positive response in the assay post first dose that was greater-than or equal to 4-fold over baseline titer levels, when baseline results were positive.
Measured: From Baseline up to 24 weeks
Pharmacokinetics (PK) Assessment: Serum Functional Dupilumab Concentration
Serum functional dupilumab concentrations were determined using an enzyme-linked immunosorbent assay (ELISA) method.
Measured: Week 0, Week 2, 6, 8, 12, 18, End of study (Week 24)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during between the first administration of study medication to the end of the 12 week Post-treatment Period. Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included both serious and non-serious AEs.
Measured: Baseline up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study start27 Jan 2016
- Primary completion3 Jan 2018
- Study completion3 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573233
- Sponsor's protocol ID
- PDY14192
- Other IDs
- 2015-001572-22, U1111-1170-7168, 2015
- Acronym
- EXPEDITION
- Status last verified
- Mar 2022
- First submitted
- 8 Oct 2015
- Last updated
- 4 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Double-blind, Placebo-controlled Study of the Effects of Dupilumab on Airway Inflammation of Adults With Persistent Asthma
- ClinicalTrials.gov ID
- NCT02573233
- Acronym / sponsor ID
- EXPEDITION / PDY14192
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 27 Jan 2016 (actual)
- Primary completion
- 3 Jan 2018 (actual)
- Study completion
- 3 Jan 2018 (actual)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Posted 28 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The total study duration for each participant was between approximately 29 and maximum of 30 weeks, consisting of a screening period of 5 weeks and optional up to 7 additional days, a treatment period of 12 weeks, and a post-treatment period of 12 weeks.
Participants who completed the treatment period could be eligible to participate in an open-label extension study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Drug: fluticasone propionate and salmeterol, Drug: budesonide and formoterol, Drug: mometasone furoate and formoterolPlacebo (for dupilumab), 2 subcutaneous injections on Day 1 (Week 1) as a loading dose followed by a single injection q2w from Week 2 to Week 14, added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. |
| Dupilumab | Experimental | Drug: Dupilumab SAR231893/REGN668, Drug: fluticasone propionate and salmeterol, Drug: budesonide and formoterol, Drug: mometasone furoate and formoterolDupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection q2w from Week 2 to Week 14, added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- Participants <18 years or >65 years.
- Fractional exhaled nitric oxide (FeNO) <26 parts per billion (ppb) at Visit 1 (Screening Visit).
- Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, eosinophilic granulomatosis with polyangiitis [Churg-Strauss Syndrome]) which could impair lung function.
- A participant who experienced an asthma exacerbation that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to Visit 1.
- A participant who had experienced an upper or lower respiratory tract infection within the 4 weeks prior to Visit 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPharmaceutical form:solution Route of administration: subcutaneous | Drug | Placebo |
| Dupilumab SAR231893/REGN668Pharmaceutical form:solution Route of administration: subcutaneous | Drug | Dupilumab |
| fluticasone propionate and salmeterolAlso: AdvairPharmaceutical form:inhalation aerosol, inhalation powder Route of administration: inhaled | Drug | Dupilumab, Placebo |
| budesonide and formoterolAlso: SymbicortPharmaceutical form:inhalation aerosol Route of administration: inhaled | Drug | Dupilumab, Placebo |
| mometasone furoate and formoterolAlso: DuleraPharmaceutical form:inhalation aerosol Route of administration: inhaled | Drug | Dupilumab, Placebo |
Primary outcome
Change From Baseline in Eosinophils Cells Count in the Bronchial Submucosa at Week 12
Time frame: Baseline, Week 12
Inflammatory cells i.e. eosinophils were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.
Change From Baseline in Mucin-Stained Area in the Bronchial Submucosa at Week 12
Time frame: Baseline, Week 12
Mucin was identified by staining with Alcian-blue periodic acid-Schiff and/or immunostaining for MUC5AC and then the mucin-positive area was measured and expressed per square millimeter.
Change From Baseline in Mast Cells Count (Chymase Positive) in the Bronchial Submucosa at Week 12
Time frame: Baseline, Week 12
Inflammatory cells i.e. mast cells were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.
Change From Baseline in Mast Cells Count (Tryptase Positive) in the Bronchial Submucosa at Week 12
Time frame: Baseline, Week 12
Inflammatory cells i.e. mast cells were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.
Change From Baseline in T-Lymphocytes Count in the Bronchial Submucosa at Week 12
Time frame: Baseline, Week 12
T-Lymphocytes i.e. CD3 positive cells were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.
Change From Baseline in T-Helper Lymphocytes Count in the Bronchial Submucosa at Week 12
Time frame: Baseline, Week 12
T-helper i.e. CD4 positive lymphocytes were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.
5 secondary outcomes
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 12
Time frame: Baseline, Week 12
Average Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 6 Through Week 12
Time frame: From Baseline to Week 6 through Week 12
Number of Participants With Antidrug Antibodies (ADA)
Time frame: From Baseline up to 24 weeks
Pharmacokinetics (PK) Assessment: Serum Functional Dupilumab Concentration
Time frame: Week 0, Week 2, 6, 8, 12, 18, End of study (Week 24)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab SAR231893/REGN668, fluticasone propionate and salmeterol and budesonide and formoterol in people with Asthma, run by Sanofi at 16 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Germany, Canada, Denmark, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Eosinophils Cells Count in the Bronchial Submucosa at Week 12 (time frame: Baseline, Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.