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Trial record 3 of 56 for:    regeneron | Open Studies

Study of REGN3500 and Dupilumab in Patients With Asthma

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by Regeneron Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03112577
First received: April 4, 2017
Last updated: April 7, 2017
Last verified: April 2017
  Purpose
To assess the effects of REGN3500, dupilumab, REGN3500 and dupilumab compared with placebo, on inflammatory gene expression after a bronchial allergen challenge (BAC) in adults with mild allergic asthma

Condition Intervention Phase
Asthma, Allergic
Drug: REGN3500
Drug: Dupilumab
Drug: Placebo
Drug: Fluticasone propionate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Difference in bronchial allergen challenge (BAC)-induced changes in 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:
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Baseline to week 42 ]
  • Severity of TEAEs [ Time Frame: Baseline to week 42 ]
  • Serum concentration-time profile of REGN3500 [ Time Frame: Baseline to week 42 ]
    Assessed by maximum plasma concentration [Cmax]

  • Immunogenicity of REGN3500 and dupilumab combined [ Time Frame: Baseline to week 42 ]
    Assessed by measurement of anti-drug antibodies (ADAs)


Estimated Enrollment: 38
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: REGN3500
REGN3500: masked and randomized dosing regimen per protocol (part 1 only)
Drug: REGN3500
Experimental: Dupilumab
Dupilumab: masked and randomized dosing regimen per protocol (part 1 only)
Drug: Dupilumab
Experimental: REGN3500 and dupilumab
REGN3500 and dupilumab: masked and randomized dosing regimen per protocol (part 1 only)
Drug: REGN3500 Drug: Dupilumab
Experimental: Placebo
Placebo: masked and randomized dosing regimen per protocol (part 1 only)
Drug: Placebo
Active Comparator: Fluticasone propionate
Fluticasone propionate: open label dosing regimen per protocol (part 2 only)
Drug: Fluticasone propionate

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03112577

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

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 )
Study First Received: April 4, 2017
Last Updated: April 7, 2017

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
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

ClinicalTrials.gov processed this record on April 28, 2017