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OpenTrials
Completed

NCT Number: NCT03112577

Study of REGN3500 and Dupilumab in Patients With Asthma

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.

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Key information

Conditions

Asthma, Allergic Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Belfast, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REGN3500

Drug

Intravenous (IV) use

Dupilumab

Drug

Subcutaneous (SC) use

Other names: Dupixent

Placebo

Drug

Matching placebo

Fluticasone propionate

Drug

Inhalation use

Primary outcomes

  1. 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 outcomes

  1. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Baseline to week 42

  2. Severity of TEAEs

    Time frame: Baseline to week 42

  3. Serum concentration-time profile of REGN3500

    Time frame: Baseline to week 42

    Assessed by maximum plasma concentration [Cmax]

  4. Serum concentration-time profile of REGN3500: Tmax (time at Cmax)

    Time frame: Baseline to week 42

  5. Serum concentration-time profile of REGN3500: AUClast (area under the curve to the last measurable concentration)

    Time frame: Baseline to week 42

  6. Immunogenicity of REGN3500 and dupilumab

    Time frame: Baseline to week 42

    Assessed by measurement of anti-drug antibodies (ADAs)

  7. Serum concentration of total IL-33 after single IV dose

    Time frame: Up to Week 42

  8. 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

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2017
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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