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

March 9, 2011
January 13, 2014
March 2011
October 2012   (final data collection date for primary outcome measure)
Number of patients experiencing an asthma exacerbation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01312961 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 Flow (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 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy, Safety, and Tolerability of SAR231893 (REGN668) in Patients With Persistent Moderate to Severe Eosinophilic Asthma
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

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Biological: 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
  • 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.
    Interventions:
    • Biological: SAR231893 (REGN668)
    • 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.
    Interventions:
    • Drug: placebo
    • Drug: Fluticasone/Salmeterol combination
    • Drug: Fluticasone
    • Drug: Albuterol
Wenzel S, Ford L, Pearlman D, Spector S, Sher L, Skobieranda F, Wang L, Kirkesseli S, Rocklin R, Bock B, Hamilton J, Ming JE, Radin A, Stahl N, Yancopoulos GD, Graham N, Pirozzi G. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med. 2013 Jun 27;368(26):2455-66. doi: 10.1056/NEJMoa1304048. Epub 2013 May 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
October 2012
October 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01312961
ACT11457, U1111-1117-7826
Not Provided
Sanofi
Sanofi
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP