NCT03112577

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2017

Typical duration for phase_1

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.8 years

First QC Date

April 4, 2017

Last Update Submit

January 16, 2020

Conditions

Asthma, Allergic

Outcome Measures

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

    Screening (pre-treatment) to week 4 after treatment initiation

Secondary Outcomes (8)

  • Incidence of Treatment Emergent Adverse Events (TEAEs)

    Baseline to week 42

  • Severity of TEAEs

    Baseline to week 42

  • Serum concentration-time profile of REGN3500

    Baseline to week 42

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

    Baseline to week 42

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

    Baseline to week 42

  • +3 more secondary outcomes

Study Arms (5)

REGN3500

EXPERIMENTAL

REGN3500: masked and randomized dosing regimen per protocol (part 1 only)

Drug: REGN3500

Dupilumab

EXPERIMENTAL

Dupilumab: masked and randomized dosing regimen per protocol (part 1 only)

Drug: Dupilumab

REGN3500 plus dupilumab

EXPERIMENTAL

REGN3500 plus dupilumab: masked and randomized dosing regimen per protocol (part 1 only)

Drug: REGN3500Drug: Dupilumab

Placebo

EXPERIMENTAL

Placebo: masked and randomized dosing regimen per protocol (part 1 only)

Drug: Placebo

Fluticasone propionate

ACTIVE COMPARATOR

Fluticasone propionate: open label dosing regimen per protocol (part 2 only)

Drug: Fluticasone propionate

Interventions

REGN3500DRUG

Intravenous (IV) use

REGN3500REGN3500 plus dupilumab
DupilumabDRUG

Subcutaneous (SC) use

Also known as: Dupixent
DupilumabREGN3500 plus dupilumab
PlaceboDRUG

Matching placebo

Placebo
Fluticasone propionateDRUG

Inhalation use

Fluticasone propionate

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

WCCT Global

Cypress, California, 90630, United States

Location

Celerion

Belfast, BT9 6AD, United Kingdom

Location

Hammersmith Medicine Research

London, NW10 7EW, United Kingdom

Location

Respiratory Clinical Trials Ltd

London, W1G 8HU, United Kingdom

Location

The Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

itepekimabdupilumabFluticasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 13, 2017

Study Start

June 15, 2017

Primary Completion

March 20, 2019

Study Completion

December 9, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

US(1)GB(4)