Status:
COMPLETED
Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Primary Objective: To evaluate the effects of SAR440340 with or without dupilumab, compared to placebo, on reducing the incidence of "loss of asthma control" (LOAC) events. Secondary Objectives: To...
Detailed Description
The total duration of the study (per participant) was approximately 36 weeks, including 4 weeks screening, 12 weeks treatment, and 20 weeks post-treatment.
Eligibility Criteria
Inclusion
- 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 percent (%) 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 microgram \[µg\]) 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 might impair lung function.
- History of life threatening asthma (i.e., severe exacerbation that required 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 Visit 2/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 was 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.
Exclusion
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2019
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT03387852
Start Date
March 12 2018
End Date
August 7 2019
Last Update
June 14 2022
Active Locations (71)
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1
Investigational Site Number 8400026
Birmingham, Alabama, United States, 35209
2
Investigational Site Number 8400004
Long Beach, California, United States, 90808
3
Investigational Site Number 8400020
Los Angeles, California, United States, 90025
4
Investigational Site Number 8400001
Rolling Hills Estates, California, United States, 90274