Study of REGN3500 and Dupilumab in Patients With Asthma

Phase 1

Completed

• Conditions: Asthma, Allergic
• Interventions: Drug: Fluticasone propionate; Drug: REGN3500; Drug: Placebo; Drug: Dupilumab

• Registration Number: NCT03112577
• Lead Sponsor: Regeneron Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-13
• Study Start: 2017-06-15
• Primary Completion: 2019-03-20
• Study Completion: 2019-12-09
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-16
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluticasone propionate	Fluticasone propionate	Fluticasone propionate: open label dosing regimen per protocol (part 2 only)
REGN3500	REGN3500	REGN3500: masked and randomized dosing regimen per protocol (part 1 only)
REGN3500 plus dupilumab	REGN3500	REGN3500 plus dupilumab: masked and randomized dosing regimen per protocol (part 1 only)
Placebo	Placebo	Placebo: masked and randomized dosing regimen per protocol (part 1 only)
Dupilumab	Dupilumab	Dupilumab: masked and randomized dosing regimen per protocol (part 1 only)
REGN3500 plus dupilumab	Dupilumab	REGN3500 plus dupilumab: masked and randomized dosing regimen per protocol (part 1 only)

Primary Outcome Measures

Name	Time	Method
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	Screening (pre-treatment) to week 4 after treatment initiation

Secondary Outcome Measures

Name	Time	Method
Difference in the BAC-induced changes in sputum inflammatory mRNA signature in individual patients treated with fluticasone	Screening (pre-treatment) to day 4 after treatment initiation
Serum concentration-time profile of REGN3500	Baseline to week 42	Assessed by maximum plasma concentration \[Cmax\]
Incidence of Treatment Emergent Adverse Events (TEAEs)	Baseline to week 42
Serum concentration-time profile of REGN3500: AUClast (area under the curve to the last measurable concentration)	Baseline to week 42
Severity of TEAEs	Baseline to week 42
Serum concentration-time profile of REGN3500: Tmax (time at Cmax)	Baseline to week 42
Immunogenicity of REGN3500 and dupilumab	Baseline to week 42	Assessed by measurement of anti-drug antibodies (ADAs)
Serum concentration of total IL-33 after single IV dose	Up to Week 42

Trial Locations

Locations (5)

WCCT Global; 🇺🇸 Cypress, California, United States

Celerion; 🇬🇧 Belfast, United Kingdom

Hammersmith Medicine Research; 🇬🇧 London, United Kingdom

Respiratory Clinical Trials Ltd; 🇬🇧 London, United Kingdom

The Medicines Evaluation Unit; 🇬🇧 Manchester, United Kingdom