Clinical trial NCT03112577: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma, Allergic
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2017-04-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: KEY Inclusion Criteria:

1. Male or female aged between 18 and 60 years
2. Has a Body Mass Index {BMI) of 17 to 33 kg/m2 at pre-study screening
3. Has a history of mild allergic asthma for at least 6 months
4. Is a non-smoker or ex-smoker for at least 12 months

KEY Exclusion Criteria:

1. Has a history of life-threatening asthma
2. Has been hospitalized or has attended the emergency room for asthma in the 12 months prior to screening
3. Has a history of severe allergies or history of an anaphylactic reaction
4. Has a history of drug or alcohol abuse within a year prior to the screening visit

Note: other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: 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
timeFrame: Screening (pre-treatment) to week 4 after treatment initiation
Secondary outcomes:
measure: Incidence of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline to week 42
measure: Severity of TEAEs
timeFrame: Baseline to week 42
measure: Serum concentration-time profile of REGN3500
timeFrame: Baseline to week 42
measure: Serum concentration-time profile of REGN3500: Tmax (time at Cmax)
timeFrame: Baseline to week 42
measure: Serum concentration-time profile of REGN3500: AUClast (area under the curve to the last measurable concentration)
timeFrame: Baseline to week 42
measure: Immunogenicity of REGN3500 and dupilumab
timeFrame: Baseline to week 42
measure: Serum concentration of total IL-33 after single IV dose
timeFrame: Up to Week 42
measure: Difference in the BAC-induced changes in sputum inflammatory mRNA signature in individual patients treated with fluticasone
timeFrame: Screening (pre-treatment) to day 4 after treatment initiation
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global
state: California
city: Belfast
country: United Kingdom
facility: Celerion
city: London
country: United Kingdom
facility: Hammersmith Medicine Research
city: London
country: United Kingdom
facility: Respiratory Clinical Trials Ltd
city: Manchester
country: United Kingdom
facility: The Medicines Evaluation Unit
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: