Back to resultsStudy of REGN3500 and Dupilumab in Patients With Asthma
Primary Purpose
Asthma, Allergic
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
REGN3500
Dupilumab
Placebo
Fluticasone propionate
Sponsored by
About this trial
This is an interventional treatment trial for Asthma, Allergic
Eligibility Criteria
KEY Inclusion Criteria:
- Male or female aged between 18 and 60 years
- Has a Body Mass Index {BMI) of 17 to 33 kg/m2 at pre-study screening
- Has a history of mild allergic asthma for at least 6 months
- Is a non-smoker or ex-smoker for at least 12 months
KEY Exclusion Criteria:
- Has a history of life-threatening asthma
- Has been hospitalized or has attended the emergency room for asthma in the 12 months prior to screening
- Has a history of severe allergies or history of an anaphylactic reaction
- Has a history of drug or alcohol abuse within a year prior to the screening visit
Note: other protocol defined inclusion/exclusion criteria apply
Sites / Locations
- WCCT Global
- Celerion
- Hammersmith Medicine Research
- Respiratory Clinical Trials Ltd
- The Medicines Evaluation Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
REGN3500
Dupilumab
REGN3500 plus dupilumab
Placebo
Fluticasone propionate
Arm Description
REGN3500: masked and randomized dosing regimen per protocol (part 1 only)
Dupilumab: masked and randomized dosing regimen per protocol (part 1 only)
REGN3500 plus dupilumab: masked and randomized dosing regimen per protocol (part 1 only)
Placebo: masked and randomized dosing regimen per protocol (part 1 only)
Fluticasone propionate: open label dosing regimen per protocol (part 2 only)
Outcomes
Primary Outcome Measures
Difference in bronchial allergen challenge (BAC)-induced changes in sputum inflammatory markers in individuals treated with REGN3500, dupilumab and the combination of REGN3500 plus dupilumab or placebo
Secondary Outcome Measures
Incidence of Treatment Emergent Adverse Events (TEAEs)
Severity of TEAEs
Serum concentration-time profile of REGN3500
Assessed by maximum plasma concentration [Cmax]
Serum concentration-time profile of REGN3500: Tmax (time at Cmax)
Serum concentration-time profile of REGN3500: AUClast (area under the curve to the last measurable concentration)
Immunogenicity of REGN3500 and dupilumab
Assessed by measurement of anti-drug antibodies (ADAs)
Serum concentration of total IL-33 after single IV dose
Difference in the BAC-induced changes in sputum inflammatory mRNA signature in individual patients treated with fluticasone
Full Information
NCT ID
NCT03112577
First Posted
April 4, 2017
Last Updated
January 16, 2020
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT03112577
Brief Title
Study of REGN3500 and Dupilumab in Patients With Asthma
Official Title
A Randomized, Placebo-controlled, Parallel Panel Study to Assess the Effects of REGN3500, Dupilumab, and Combination of REGN3500 Plus Dupilumab on Markers of Inflammation After Bronchial Allergen Challenge in Patients With Allergic Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
March 20, 2019 (Actual)
Study Completion Date
December 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To assess the effects of REGN3500, dupilumab, and REGN3500 plus dupilumab, compared with placebo, on changes in inflammatory gene expression signatures in sputum induced after a bronchial allergen challenge (BAC) in adults with mild allergic asthma, at week 4 after treatment initiation compared with those at screening.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Allergic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
REGN3500
Arm Type
Experimental
Arm Description
REGN3500: masked and randomized dosing regimen per protocol (part 1 only)
Arm Title
Dupilumab
Arm Type
Experimental
Arm Description
Dupilumab: masked and randomized dosing regimen per protocol (part 1 only)
Arm Title
REGN3500 plus dupilumab
Arm Type
Experimental
Arm Description
REGN3500 plus dupilumab: masked and randomized dosing regimen per protocol (part 1 only)
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo: masked and randomized dosing regimen per protocol (part 1 only)
Arm Title
Fluticasone propionate
Arm Type
Active Comparator
Arm Description
Fluticasone propionate: open label dosing regimen per protocol (part 2 only)
Intervention Type
Drug
Intervention Name(s)
REGN3500
Intervention Description
Intravenous (IV) use
Intervention Type
Drug
Intervention Name(s)
Dupilumab
Other Intervention Name(s)
Dupixent
Intervention Description
Subcutaneous (SC) use
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate
Intervention Description
Inhalation use
Primary Outcome Measure Information:
Title
Difference in bronchial allergen challenge (BAC)-induced changes in sputum inflammatory markers in individuals treated with REGN3500, dupilumab and the combination of REGN3500 plus dupilumab or placebo
Time Frame
Screening (pre-treatment) to week 4 after treatment initiation
Secondary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame
Baseline to week 42
Title
Severity of TEAEs
Time Frame
Baseline to week 42
Title
Serum concentration-time profile of REGN3500
Description
Assessed by maximum plasma concentration [Cmax]
Time Frame
Baseline to week 42
Title
Serum concentration-time profile of REGN3500: Tmax (time at Cmax)
Time Frame
Baseline to week 42
Title
Serum concentration-time profile of REGN3500: AUClast (area under the curve to the last measurable concentration)
Time Frame
Baseline to week 42
Title
Immunogenicity of REGN3500 and dupilumab
Description
Assessed by measurement of anti-drug antibodies (ADAs)
Time Frame
Baseline to week 42
Title
Serum concentration of total IL-33 after single IV dose
Time Frame
Up to Week 42
Title
Difference in the BAC-induced changes in sputum inflammatory mRNA signature in individual patients treated with fluticasone
Time Frame
Screening (pre-treatment) to day 4 after treatment initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
KEY Inclusion Criteria:
Male or female aged between 18 and 60 years
Has a Body Mass Index {BMI) of 17 to 33 kg/m2 at pre-study screening
Has a history of mild allergic asthma for at least 6 months
Is a non-smoker or ex-smoker for at least 12 months
KEY Exclusion Criteria:
Has a history of life-threatening asthma
Has been hospitalized or has attended the emergency room for asthma in the 12 months prior to screening
Has a history of severe allergies or history of an anaphylactic reaction
Has a history of drug or alcohol abuse within a year prior to the screening visit
Note: other protocol defined inclusion/exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
WCCT Global
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
Celerion
City
Belfast
ZIP/Postal Code
BT9 6AD
Country
United Kingdom
Facility Name
Hammersmith Medicine Research
City
London
ZIP/Postal Code
NW10 7EW
Country
United Kingdom
Facility Name
Respiratory Clinical Trials Ltd
City
London
ZIP/Postal Code
W1G 8HU
Country
United Kingdom
Facility Name
The Medicines Evaluation Unit
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study of REGN3500 and Dupilumab in Patients With Asthma
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