Study of REGN3500 and Dupilumab in Patients With Asthma

Asthma, Allergic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112577
• Other study ID #: R3500-AS-1633
• Secondary ID: 2016-003165-26SA
• Status: Completed
• Phase: Phase 1
• Start date: June 15, 2017
• Est. completion date: December 9, 2019

Study information

• Verified date: January 2020
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 9, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma, Allergic

Intervention

Drug:
• REGN3500
Intravenous (IV) use
• Dupilumab
Subcutaneous (SC) use
• Placebo
Matching placebo
• Fluticasone propionate
Inhalation use

Locations

Country	Name	City	State
United Kingdom	Celerion	Belfast
United Kingdom	Hammersmith Medicine Research	London
United Kingdom	Respiratory Clinical Trials Ltd	London
United Kingdom	The Medicines Evaluation Unit	Manchester
United States	WCCT Global	Cypress	California

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Treatment Emergent Adverse Events (TEAEs)		Baseline to week 42
Secondary	Severity of TEAEs		Baseline to week 42
Secondary	Serum concentration-time profile of REGN3500	Assessed by maximum plasma concentration [Cmax]	Baseline to week 42
Secondary	Serum concentration-time profile of REGN3500: Tmax (time at Cmax)		Baseline to week 42
Secondary	Serum concentration-time profile of REGN3500: AUClast (area under the curve to the last measurable concentration)		Baseline to week 42
Secondary	Immunogenicity of REGN3500 and dupilumab	Assessed by measurement of anti-drug antibodies (ADAs)	Baseline to week 42
Secondary	Serum concentration of total IL-33 after single IV dose		Up to Week 42
Secondary	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