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

  Show 50 Study Locations
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
Fluticasone
Salmeterol
Albuterol
Fluticasone, salmeterol drug combination
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists

ClinicalTrials.gov processed this record on September 16, 2014