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Study of REGN3500 and Dupilumab in Patients With Asthma

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ClinicalTrials.gov Identifier: NCT03112577
Recruitment Status : Active, not recruiting
First Posted : April 13, 2017
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Asthma, Allergic Drug: REGN3500 Drug: Dupilumab Drug: Placebo Drug: Fluticasone propionate Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : March 20, 2019
Estimated Study Completion Date : December 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: REGN3500
REGN3500: masked and randomized dosing regimen per protocol (part 1 only)
Drug: REGN3500
Intravenous (IV) use

Experimental: Dupilumab
Dupilumab: masked and randomized dosing regimen per protocol (part 1 only)
Drug: Dupilumab
Subcutaneous (SC) use
Other Name: Dupixent

Experimental: REGN3500 plus dupilumab
REGN3500 plus dupilumab: masked and randomized dosing regimen per protocol (part 1 only)
Drug: REGN3500
Intravenous (IV) use

Drug: Dupilumab
Subcutaneous (SC) use
Other Name: Dupixent

Experimental: Placebo
Placebo: masked and randomized dosing regimen per protocol (part 1 only)
Drug: Placebo
Matching placebo

Active Comparator: Fluticasone propionate
Fluticasone propionate: open label dosing regimen per protocol (part 2 only)
Drug: Fluticasone propionate
Inhalation use




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112577


Locations
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United States, California
WCCT Global
Cypress, California, United States, 90630
United Kingdom
Celerion
Belfast, United Kingdom, BT9 6AD
Hammersmith Medicine Research
London, United Kingdom, NW10 7EW
Respiratory Clinical Trials Ltd
London, United Kingdom, W1G 8HU
The Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03112577     History of Changes
Other Study ID Numbers: R3500-AS-1633
2016-003165-26 ( EudraCT Number )
SAR440340 ( Other Identifier: Sanofi )
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Antibodies, Monoclonal
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Immunologic Factors