Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants
NCT ID: NCT03387852
Last Updated: 2022-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
296 participants
INTERVENTIONAL
2018-03-12
2019-08-07
Brief Summary
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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 evaluate the effects of SAR440340/REGN3500 and coadministration of SAR440340 and dupilumab, compared with placebo, on forced expiratory volume in 1 second (FEV1).
To evaluate the effects of coadministration of SAR440340 and dupilumab, compared with SAR440340 and compared with dupilumab, on FEV1.
To assess safety and tolerability of SAR440340 alone and in coadministration with dupilumab.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SAR440340
Participants received 2 injections of SAR440340 300 milligram (mg) along with 1 injection of dupilumab placebo, subcutaneous (SC) once every 2 weeks (Q2W) for 12 weeks.
SAR440340
Pharmaceutical form: Solution for Injection, Route of administration: SC
Fluticasone or Fluticasone/salmeterol combination
Pharmaceutical form: Aerosol, dry powder, Route of administration: Inhaled
Placebo for dupilumab
Pharmaceutical form: Solution for Injection, Route of administration: SC
Dupilumab
Participants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks.
Dupilumab
Pharmaceutical form: Solution for Injection, Route of administration: SC
Fluticasone or Fluticasone/salmeterol combination
Pharmaceutical form: Aerosol, dry powder, Route of administration: Inhaled
Placebo for SAR440340
Pharmaceutical form: Solution for Injection, Route of administration: SC
SAR440340 + Dupilumab
Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.
SAR440340
Pharmaceutical form: Solution for Injection, Route of administration: SC
Dupilumab
Pharmaceutical form: Solution for Injection, Route of administration: SC
Fluticasone or Fluticasone/salmeterol combination
Pharmaceutical form: Aerosol, dry powder, Route of administration: Inhaled
Placebo
Participants received 2 SC injections of SAR440340 placebo along with 1 SC injection of dupilumab placebo Q2W for 12 weeks.
Fluticasone or Fluticasone/salmeterol combination
Pharmaceutical form: Aerosol, dry powder, Route of administration: Inhaled
Placebo for SAR440340
Pharmaceutical form: Solution for Injection, Route of administration: SC
Placebo for dupilumab
Pharmaceutical form: Solution for Injection, Route of administration: SC
Interventions
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SAR440340
Pharmaceutical form: Solution for Injection, Route of administration: SC
Dupilumab
Pharmaceutical form: Solution for Injection, Route of administration: SC
Fluticasone or Fluticasone/salmeterol combination
Pharmaceutical form: Aerosol, dry powder, Route of administration: Inhaled
Placebo for SAR440340
Pharmaceutical form: Solution for Injection, Route of administration: SC
Placebo for dupilumab
Pharmaceutical form: Solution for Injection, Route of administration: SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 8400026
Birmingham, Alabama, United States
Investigational Site Number 8400004
Long Beach, California, United States
Investigational Site Number 8400020
Los Angeles, California, United States
Investigational Site Number 8400001
Rolling Hills Estates, California, United States
Investigational Site Number 8400013
San Jose, California, United States
Investigational Site Number 8400009
Stockton, California, United States
Investigational Site Number 8400016
Colorado Springs, Colorado, United States
Investigational Site Number 8400021
Ann Arbor, Michigan, United States
Investigational Site Number 8400022
Minneapolis, Minnesota, United States
Investigational Site Number 8400007
Papillion, Nebraska, United States
Investigational Site Number 8400025
Edmond, Oklahoma, United States
Investigational Site Number 8400011
Medford, Oregon, United States
Investigational Site Number 8400024
Portland, Oregon, United States
Investigational Site Number 8400010
Dallas, Texas, United States
Investigational Site Number 8400023
Dallas, Texas, United States
Investigational Site Number 8400006
Plano, Texas, United States
Investigational Site Number 8400008
Murray, Utah, United States
Investigational Site Number 8400014
Milwaukee, Wisconsin, United States
Investigational Site Number 0320001
Buenos Aires, , Argentina
Investigational Site Number 0320003
Caba, , Argentina
Investigational Site Number 0320002
Caba, , Argentina
Investigational Site Number 0320004
Caba, , Argentina
Investigational Site Number 0320005
Mendoza, , Argentina
Investigational Site Number 1520002
Quillota, , Chile
Investigational Site Number 1520001
Santiago, , Chile
Investigational Site Number 1520009
Santiago, , Chile
Investigational Site Number 1520008
Santiago, , Chile
Investigational Site Number 1520007
Santiago, , Chile
Investigational Site Number 1520004
Santiago, , Chile
Investigational Site Number 1520005
Talca, , Chile
Investigational Site Number 1520003
Viña del Mar, , Chile
Investigational Site Number 4840005
Chihuahua City, , Mexico
Investigational Site Number 4840004
Durango, , Mexico
Investigational Site Number 4840002
Guadalajara, , Mexico
Investigational Site Number 4840006
Monterrey, , Mexico
Investigational Site Number 4840001
Monterrey, , Mexico
Investigational Site Number 4840003
Veracruz, , Mexico
Investigational Site Number 6160001
Bialystok, , Poland
Investigational Site Number 6160008
Bialystok, , Poland
Investigational Site Number 6160005
Bydgoszcz, , Poland
Investigational Site Number 6160007
Krakow, , Poland
Investigational Site Number 6160002
Poznan, , Poland
Investigational Site Number 6160006
Poznan, , Poland
Investigational Site Number 6160003
Żnin, , Poland
Investigational Site Number 6430003
Moscow, , Russia
Investigational Site Number 6430001
Moscow, , Russia
Investigational Site Number 6430005
Moscow, , Russia
Investigational Site Number 6430008
Ryazan, , Russia
Investigational Site Number 6430007
Saint Petersburg, , Russia
Investigational Site Number 6430010
Saint Petersburg, , Russia
Investigational Site Number 6430006
Saint Petersburg, , Russia
Investigational Site Number 6430009
Stavropol, , Russia
Investigational Site Number 6430004
Ulyanovsk, , Russia
Investigational Site Number 7920004
Ankara, , Turkey (Türkiye)
Investigational Site Number 7920003
Bursa, , Turkey (Türkiye)
Investigational Site Number 7920001
Istanbul, , Turkey (Türkiye)
Investigational Site Number 7920006
Izmir, , Turkey (Türkiye)
Investigational Site Number 7920007
Izmir, , Turkey (Türkiye)
Investigational Site Number 7920008
Kırıkkale, , Turkey (Türkiye)
Investigational Site Number 7920002
Mersin, , Turkey (Türkiye)
Investigational Site Number 7920009
Rize, , Turkey (Türkiye)
Investigational Site Number 8040008
Chernivtsi, , Ukraine
Investigational Site Number 8040012
Ivano-Frankivsk, , Ukraine
Investigational Site Number 8040002
Kharkiv, , Ukraine
Investigational Site Number 8040009
Kharkiv, , Ukraine
Investigational Site Number 8040011
Kharkiv, , Ukraine
Investigational Site Number 8040007
Kyiv, , Ukraine
Investigational Site Number 8040001
Kyiv, , Ukraine
Investigational Site Number 8040006
Odesa, , Ukraine
Investigational Site Number 8040003
Ternopil, , Ukraine
Investigational Site Number 8040005
Vinnytsia, , Ukraine
Countries
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References
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Yin Z, Zhou Y, Turnquist HR, Liu Q. Neuro-epithelial-ILC2 crosstalk in barrier tissues. Trends Immunol. 2022 Nov;43(11):901-916. doi: 10.1016/j.it.2022.09.006. Epub 2022 Oct 14.
Wechsler ME, Ruddy MK, Pavord ID, Israel E, Rabe KF, Ford LB, Maspero JF, Abdulai RM, Hu CC, Martincova R, Jessel A, Nivens MC, Amin N, Weinreich DM, Yancopoulos GD, Goulaouic H. Efficacy and Safety of Itepekimab in Patients with Moderate-to-Severe Asthma. N Engl J Med. 2021 Oct 28;385(18):1656-1668. doi: 10.1056/NEJMoa2024257.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-003289-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1194-2185
Identifier Type: OTHER
Identifier Source: secondary_id
ACT15102
Identifier Type: -
Identifier Source: org_study_id
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