Study of REGN3500 and Dupilumab in Patients With Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2019-12-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma

NCT02573233

Asthma

COMPLETED PHASE2

Study of Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REGN3500 in Adults With Moderate Asthma

NCT02999711

Asthma Moderate Asthma

COMPLETED PHASE1

Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma

NCT03782532

Asthma

COMPLETED PHASE3

Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants

NCT03387852

Asthma

COMPLETED PHASE2

Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma

NCT01312961

Asthma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma, Allergic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

REGN3500

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

Group Type EXPERIMENTAL

REGN3500

Intervention Type DRUG

Intravenous (IV) use

Dupilumab

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

Group Type EXPERIMENTAL

Dupilumab

Intervention Type DRUG

Subcutaneous (SC) use

REGN3500 plus dupilumab

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

Group Type EXPERIMENTAL

REGN3500

Intervention Type DRUG

Intravenous (IV) use

Dupilumab

Intervention Type DRUG

Subcutaneous (SC) use

Placebo

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching placebo

Fluticasone propionate

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

Group Type ACTIVE_COMPARATOR

Fluticasone propionate

Intervention Type DRUG

Inhalation use

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

REGN3500

Intravenous (IV) use

Intervention Type DRUG

Dupilumab

Subcutaneous (SC) use

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Fluticasone propionate

Inhalation use

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dupixent

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No