Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants

• Status: Completed
• Trial end date: 2019-08-07
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To evaluate the effects of SAR440340/REGN3500 with or without dupilumab, compared to placebo, on reducing the incidence of "loss of asthma control" (LOAC) events.

Secondary Objectives:

To evaluate the effects of SAR440340/REGN3500 and coadministration of SAR440340/REGN3500 and dupilumab, compared with placebo, on forced expiratory volume in 1 second (FEV1).

To evaluate the effects of coadministration of SAR440340/REGN3500 and dupilumab, compared with SAR440340 and compared with dupilumab, on FEV1.

To assess safety and tolerability of SAR440340/REGN3500 alone and in coadministration with dupilumab.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Fluticasone; Fluticasone-Salmeterol Drug Combination; Salmeterol Xinafoate; Xhance

Criteria

Inclusion criteria :

• Adult participants with a physician diagnosis of asthma for at least 12 months based on the Global Initiative for Asthma (GINA) 2017 Guidelines.

• Participants with existing treatment with medium to high dose ICS (greater than or equal to [≥] 250 microgram (mcg) of fluticasone propionate twice a day (BID) or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or clinically comparable) in combination with a LABA as second controller for at least 3 months with a stable dose ≥1 month prior to Visit 1.

• Participants with pre-bronchodilator FEV1 greater than (>) 40 percentage (%) of predicted normal at Visit 1/Screening. Pre-bronchodilator FEV1 ≥50% but less than or equal to (≤) 85% of predicted normal at Visit 2/Baseline.

• Participants with reversibility of at least 12% and 200 milliliters (mL) in FEV1 after administration of 2 to 4 puffs (200-400 mcg) of albuterol/salbutamol or levalbuterol/levosalbutamol during screening or documented history of a reversibility test that meets this criteria within 12 months prior to Visit 1 or documented positive response to methacholine challenge (a decrease in FEV by 20% [PC20] of less than [<] 8 milligram per milliliter [mg/mL]) within 12 months prior to Visit 1/Screening is considered acceptable to meet this inclusion criterion.

• Participants had experienced, within 1 year prior to Visit 1, any of the following events at least once:

• Treatment with a systemic steroid (oral or parenteral) for worsening asthma;

• Hospitalization or emergency medical care visit for worsening asthma.

• Signed written informed consent.

Exclusion criteria:

• Participants <18 years or >70 years of age (i.e., have reached the age of 71 at the screening visit).

• Participants with body mass index (BMI) <16.

• Chronic lung disease (for example, chronic obstructive pulmonary disease [COPD], or idiopathic pulmonary fibrosis [IPF]), which may impair lung function.

• History of life threatening asthma (i.e., severe exacerbation that requires intubation).

• Co-morbid disease that might interfere with the evaluation of investigational medicinal product (IMP).

• Participants with any of the following events within the 4 weeks prior to their Screening Visit 1:

• Treatment with 1 or more systemic (oral and/or parenteral) steroid bursts for worsening asthma;

• Hospitalization or emergency medical care visit for worsening asthma.

• Asthma Control Questionnaire 5-question version (ACQ-5) score <1.25 or >3.0 at V2/randomization. During the screening period, an ACQ-5 of up to ≤4 was acceptable.

• Anti-immunoglobulin E (IgE) therapy (e.g., omalizumab [Xolair®]) within 130 days prior to Visit 1 or any other biologic therapy (including anti interleukin-5 [anti-IL5] monoclonal antibodies [mAb]) or systemic immunosuppressant (e.g., methotrexate) to treat inflammatory disease or autoimmune disease (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) and other diseases, within 2 months or 5 half-lives prior to Visit 1, whichever is longer.

• Participants with a history of a systemic hypersensitivity reaction to a biologic drug.

• Participants on or initiation of bronchial thermoplasty within 2 years prior to Visit 1 or plan to begin therapy during the screening period or the randomized treatment period.

• Current smoker or cessation of smoking within the 6 months prior to Visit 1.

• Previous smoker with a smoking history >10 pack-years.

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