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

Overview[ - collapse ][ - ]

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.
ConditionAsthma
InterventionBiological: SAR231893 (REGN668)
Drug: placebo
Drug: Fluticasone/Salmeterol combination
Drug: Fluticasone
Drug: Albuterol
PhasePhase 2
SponsorSanofi
Responsible PartySanofi
ClinicalTrials.gov IdentifierNCT01312961
First ReceivedMarch 9, 2011
Last UpdatedJanuary 13, 2014
Last verifiedJanuary 2013

Tracking Information[ + expand ][ + ]

First Received DateMarch 9, 2011
Last Updated DateJanuary 13, 2014
Start DateMarch 2011
Estimated Primary Completion DateOctober 2012
Current Primary Outcome MeasuresNumber of patients experiencing an asthma exacerbation [Time Frame: 12 weeks] [Designated as safety issue: No]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy, Safety, and Tolerability of SAR231893 (REGN668) in Patients With Persistent Moderate to Severe Eosinophilic Asthma
Official TitleRandomized, 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
Brief Summary
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.
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.
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionAsthma
InterventionBiological: SAR231893 (REGN668)
Pharmaceutical form:Solution in a 5 mL glass vial Route of administration: Subcutaneous injection
Drug: placebo
Pharmaceutical form:Solution in a 5 mL glass vial
Route of administration: Subcutaneous injection
Drug: Fluticasone/Salmeterol combination
Drug: Fluticasone
Drug: Albuterol
Study Arm (s)
  • 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.
  • 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.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment104
Estimated Completion DateOctober 2012
Estimated Primary Completion DateOctober 2012
Eligibility 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01312961
Other Study ID NumbersACT11457
Has Data Monitoring CommitteeNot Provided
Information Provided BySanofi
Study SponsorSanofi
CollaboratorsRegeneron Pharmaceuticals
Investigators Study Director: Clinical Sciences & Operations Sanofi
Verification DateJanuary 2013

Locations[ + expand ][ + ]

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
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
Investigational Site Number 840026
New Haven, Connecticut, United States, 06510
Investigational Site Number 840044
Tallahassee, Florida, United States, 32308
Investigational Site Number 840029
Tampa, Florida, United States, 33612
Investigational Site Number 840028
Indianapolis, Indiana, United States, 46208
Investigational Site Number 840038
Iowa City, Iowa, United States, 52240
Investigational Site Number 840021
Overland Park, Kansas, United States, 66210
Investigational Site Number 840053
Owensboro, Kentucky, United States, 42303
Investigational Site Number 840014
Baltimore, Maryland, United States, 21287
Investigational Site Number 840015
North Dartmouth, Massachusetts, United States, 02747
Investigational Site Number 840003
Minneapolis, Minnesota, United States, 55402
Investigational Site Number 840010
Minneapolis, Minnesota, United States, 55402
Investigational Site Number 840013
St Louis, Missouri, United States, 63141
Investigational Site Number 840006
St Louis, Missouri, United States, 63110
Investigational Site Number 840022
Bozeman, Montana, United States, 59718
Investigational Site Number 840025
Omaha, Nebraska, United States, 68131
Investigational Site Number 840008
Papillion, Nebraska, United States, 27103
Investigational Site Number 840018
Princeton, New Jersey, United States, 08540
Investigational Site Number 840004
Winston Salem, North Carolina, United States, 27157-1071
Investigational Site Number 840023
Sylvania, Ohio, United States, 43560
Investigational Site Number 840045
Oklahoma City, Oklahoma, United States, 73120
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
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
Investigational Site Number 840027
Charleston, South Carolina, United States, 29407
Investigational Site Number 840030
El Paso, Texas, United States, 79902
Investigational Site Number 840050
San Antonio, Texas, United States, 78229
Investigational Site Number 840052
South Burlington, Vermont, United States, 05403
Investigational Site Number 840049
Richmond, Virginia, United States, 23229
Investigational Site Number 840020
Seattle, Washington, United States, 98105
Investigational Site Number 840019
Tacoma, Washington, United States, 98415-0299
Investigational Site Number 840034
Madison, Wisconsin, United States, 53792