Efficacy, Safety, and Tolerability of SAR231893 (REGN668) in Patients With Persistent Moderate to Severe Eosinophilic Asthma

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01312961
First received: March 9, 2011
Last updated: January 13, 2014
Last verified: January 2013
  Purpose

Primary Objective:

Investigate the effects of SAR231893 (REGN668) administered subcutaneously (SC) once weekly for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbations in patients with persistent moderate to severe eosinophilic asthma.

Secondary Objectives:

Assess the safety and tolerability of SAR231893 (REGN668) administered SC once weekly for 12 weeks in patients with persistent moderate to severe eosinophilic asthma.

Assess SAR231893 (REGN668) serum concentrations following once weekly SC dosing for 12 weeks in patients with persistent moderate to severe eosinophilic asthma.


Condition Intervention Phase
Asthma
Biological: SAR231893 (REGN668)
Drug: placebo
Drug: Fluticasone/Salmeterol combination
Drug: Fluticasone
Drug: Albuterol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of SAR231893/REGN668 Administered Subcutaneously Once Weekly for 12 Weeks in Patients With Persistent Moderate to Severe Eosinophilic Asthma Who Are Partially Controlled/Uncontrolled by Inhaled Corticosteroid Plus Long-acting beta2 Agonist Therapy

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of patients experiencing an asthma exacerbation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to asthma exacerbation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Forced Expiratory Flow in 1 second (FEV1) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Peak Expiratory Fflow (PEF) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the Juniper Asthma Control Questionnaire (Juniper ACQ - 5-question version) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in 22-item Sinonasal Outcome Test (SNOT-22) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the number of Albuterol inhalation per day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic (PK) profile of SAR231893 (REGN668): maximum concentration (Cmax), time to Cmax (tmax), area under concentration curve (AUC0-τ) [ Time Frame: 18-20 weeks ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: March 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR231893 (REGN668)

SAR231893 (REGN668) once weekly in the morning in the clinic for 12 weeks on top of:

  • Fluticasone/Salmeterol combination therapy during the background therapy stable phase
  • Fluticasone monotherapy during the background therapy withdrawal phase (dose decrease) Albuterol inhalation can be used as rescue medication as needed throughout the study.
Biological: SAR231893 (REGN668)
Pharmaceutical form:Solution in a 5 mL glass vial Route of administration: Subcutaneous injection
Drug: Fluticasone/Salmeterol combination Drug: Fluticasone Drug: Albuterol
Placebo Comparator: Placebo

Matching placebo once weekly in the morning in the clinic for 12 weeks on top of:

  • Fluticasone/Salmeterol combination therapy during the background therapy stable phase
  • Fluticasone monotherapy during the background therapy withdrawal phase (dose decrease) Albuterol inhalation can be used as rescue medication as needed throughout the study.
Drug: placebo

Pharmaceutical form:Solution in a 5 mL glass vial

Route of administration: Subcutaneous injection

Drug: Fluticasone/Salmeterol combination Drug: Fluticasone Drug: Albuterol

Detailed Description:

The total duration of the study period per patient is 18-20 weeks broken down as follows:

  • Screening period: up to 14 days,
  • Treatment period: 12 weeks,
  • Follow-up period: 6-8 weeks.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Medical diagnosis of persistent asthma for at least 12 months whose:

  • airway inflammation likely to be eosinophilic,
  • asthma partially controlled or uncontrolled on Inhaled Corticosteroid (ICS) plus Long-Acting Beta2 Agonist (LABA) therapy.
  • On a stable dose of either Fluticasone/Salmeterol, Budesonide/Formoterol, Mometasone/Formoterol combination therapy for at least 1 month prior to screening.
  • Signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form.

Exclusion criteria:

  • Less than 18 years or greater than 65 years of age.
  • Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further evaluation.
  • Chronic obstructive pulmonary disease and/or other lung diseases impairing Pulmonary Function Tests.
  • Beta-adrenergic receptor blockers required for any reason.
  • Current smoker or cessation of smoking within the 6 months prior to screening.
  • Previous smoking with a smoking history > 10 cigarette pack/years.
  • Participation in another study within 6 months prior to screening if the study medication is an antibody or within 30 days prior to screening for all other study medications.
  • Known or suspected non-compliance, alcohol or drug abuse.
  • Inability to follow the procedures of the study (eg, due to language problems, psychological disorders).
  • Concomitant severe diseases or diseases for which the use of ICS or longacting beta2 agonists are contraindicated.
  • Known allergy to doxycycline or related compounds.
  • Pregnancy or intention to become pregnant during the course of the study, breast feeding, or unwillingness to use a highly effective method of contraception throughout the study in women of childbearing potential.
  • Recent history of a parasitic infection or travel to a parasitic endemic area within 6 months prior to screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  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: NCT01312961

  Hide Study Locations
Locations
United States, California
Investigational Site Number 840047
Anaheim, California, United States, 92804
Investigational Site Number 840046
Long Beach, California, United States, 90806
Investigational Site Number 840032
Los Angeles, California, United States, 90025
Investigational Site Number 840036
Los Angeles, California, United States, 90048
Investigational Site Number 840005
Mission Viejo, California, United States, 92691
Investigational Site Number 840007
Orange, California, United States, 92868
Investigational Site Number 840048
Riverside, California, United States, 92506
Investigational Site Number 840035
Rolling Hills Estates, California, United States, 90274
Investigational Site Number 840041
San Francisco, California, United States, 94143
Investigational Site Number 840042
San Francisco, California, United States, 94143
Investigational Site Number 840039
San Jose, California, United States, 95117
Investigational Site Number 840024
Santa Rosa, California, United States, 95405
Investigational Site Number 840002
Stockton, California, United States, 95207
United States, Colorado
Investigational Site Number 840031
Colorado Springs, Colorado, United States, 80907
Investigational Site Number 840017
Denver, Colorado, United States, 80230
Investigational Site Number 840011
Denver, Colorado, United States, 80206
United States, Connecticut
Investigational Site Number 840026
New Haven, Connecticut, United States, 06510
United States, Florida
Investigational Site Number 840044
Tallahassee, Florida, United States, 32308
Investigational Site Number 840029
Tampa, Florida, United States, 33612
United States, Indiana
Investigational Site Number 840028
Indianapolis, Indiana, United States, 46208
United States, Iowa
Investigational Site Number 840038
Iowa City, Iowa, United States, 52240
United States, Kansas
Investigational Site Number 840021
Overland Park, Kansas, United States, 66210
United States, Kentucky
Investigational Site Number 840053
Owensboro, Kentucky, United States, 42303
United States, Maryland
Investigational Site Number 840014
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Investigational Site Number 840015
North Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
Investigational Site Number 840003
Minneapolis, Minnesota, United States, 55402
Investigational Site Number 840010
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Investigational Site Number 840013
St Louis, Missouri, United States, 63141
Investigational Site Number 840006
St Louis, Missouri, United States, 63110
United States, Montana
Investigational Site Number 840022
Bozeman, Montana, United States, 59718
United States, Nebraska
Investigational Site Number 840025
Omaha, Nebraska, United States, 68131
Investigational Site Number 840008
Papillion, Nebraska, United States, 27103
United States, New Jersey
Investigational Site Number 840018
Princeton, New Jersey, United States, 08540
United States, North Carolina
Investigational Site Number 840004
Winston Salem, North Carolina, United States, 27157-1071
United States, Ohio
Investigational Site Number 840023
Sylvania, Ohio, United States, 43560
United States, Oklahoma
Investigational Site Number 840045
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Investigational Site Number 840001
Lake Oswego, Oregon, United States, 97035
Investigational Site Number 840012
Medford, Oregon, United States, 97504
Investigational Site Number 840016
Portland, Oregon, United States, 97209
United States, Pennsylvania
Investigational Site Number 840040
Hershey, Pennsylvania, United States, 17033
Investigational Site Number 840037
Pittsburgh, Pennsylvania, United States, 15213
Investigational Site Number 840009
Upland, Pennsylvania, United States, 19013
United States, South Carolina
Investigational Site Number 840027
Charleston, South Carolina, United States, 29407
United States, Texas
Investigational Site Number 840030
El Paso, Texas, United States, 79902
Investigational Site Number 840050
San Antonio, Texas, United States, 78229
United States, Vermont
Investigational Site Number 840052
South Burlington, Vermont, United States, 05403
United States, Virginia
Investigational Site Number 840049
Richmond, Virginia, United States, 23229
United States, Washington
Investigational Site Number 840020
Seattle, Washington, United States, 98105
Investigational Site Number 840019
Tacoma, Washington, United States, 98415-0299
United States, Wisconsin
Investigational Site Number 840034
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01312961     History of Changes
Other Study ID Numbers: ACT11457, U1111-1117-7826
Study First Received: March 9, 2011
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Pulmonary Eosinophilia
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Albuterol
Salmeterol
Fluticasone
Fluticasone, salmeterol drug combination
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents

ClinicalTrials.gov processed this record on July 22, 2014