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AsthmaPhase 2NCT03387852

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

A Phase 2 study testing SAR440340, Dupilumab and Fluticasone or Fluticasone/salmeterol combination in people with Asthma, run by Sanofi at 71 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 evaluate the effects of SAR440340/REGN3500 and coadministration of SAR440340 and dupilumab, compared with placebo, on… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Asthma
What is being tested?
SAR440340, Dupilumab and Fluticasone or Fluticasone/salmeterol combination
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
296 participants
Where
71 sitesin 8 countries
Study dates
12 Mar 2018to 7 Aug 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 15Show fewer
  • 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.

Trial locations and contacts

71 sites in 8 countries.

71 sites in 8 countries

United States18 sites

  • Investigational Site Number 8400021

    Ann Arbor, Michigan, 48109

  • Investigational Site Number 8400026

    Birmingham, Alabama, 35209

  • Investigational Site Number 8400016

    Colorado Springs, Colorado, 80907

  • Investigational Site Number 8400010

    Dallas, Texas, 75231

  • Investigational Site Number 8400023

    Dallas, Texas, 75231

  • Investigational Site Number 8400025

    Edmond, Oklahoma, 73034

  • Investigational Site Number 8400004

    Long Beach, California, 90808

  • Investigational Site Number 8400020

    Los Angeles, California, 90025

  • Investigational Site Number 8400011

    Medford, Oregon, 97504

  • Investigational Site Number 8400014

    Milwaukee, Wisconsin, 53219

  • Investigational Site Number 8400022

    Minneapolis, Minnesota, 55402

  • Investigational Site Number 8400008

    Murray, Utah, 84107

  • Investigational Site Number 8400007

    Papillion, Nebraska, 27103

  • Investigational Site Number 8400006

    Plano, Texas, 75093

  • Investigational Site Number 8400024

    Portland, Oregon, 97209

  • Investigational Site Number 8400001

    Rolling Hills Estates, California, 90274

  • Investigational Site Number 8400013

    San Jose, California, 95117

  • Investigational Site Number 8400009

    Stockton, California, 95207

Other trials in United States

Ukraine10 sites

  • Investigational Site Number 8040008

    Chernivtsi, 58001

  • Investigational Site Number 8040012

    Ivano-Frankivsk, 76000

  • Investigational Site Number 8040002

    Kharkiv, 61039

  • Investigational Site Number 8040009

    Kharkiv, 61124

  • Investigational Site Number 8040011

    Kharkiv, 61166

  • Investigational Site Number 8040007

    Kyiv, 02091

  • Investigational Site Number 8040001

    Kyiv, 02125

  • Investigational Site Number 8040006

    Odesa, 65025

  • Investigational Site Number 8040003

    Ternopil, 46000

  • Investigational Site Number 8040005

    Vinnytsia, 21001

Other trials in Ukraine

Russia9 sites

  • Investigational Site Number 6430003

    Moscow, 109240

  • Investigational Site Number 6430001

    Moscow, 109544

  • Investigational Site Number 6430005

    Moscow, 115280

  • Investigational Site Number 6430008

    Ryazan, 390039

  • Investigational Site Number 6430007

    Saint Petersburg, 193231

  • Investigational Site Number 6430010

    Saint Petersburg, 194291

  • Investigational Site Number 6430006

    Saint Petersburg, 194354

  • Investigational Site Number 6430009

    Stavropol, 355030

  • Investigational Site Number 6430004

    Ulyanovsk, 432017

Other trials in Russia

Chile8 sites

  • Investigational Site Number 1520002

    Quillota, 2260877

  • Investigational Site Number 1520001

    Santiago, 7500692

  • Investigational Site Number 1520009

    Santiago, 7500710

  • Investigational Site Number 1520008

    Santiago, 8207257

  • Investigational Site Number 1520007

    Santiago, 8330336

  • Investigational Site Number 1520004

    Santiago, 8910131

  • Investigational Site Number 1520005

    Talca

  • Investigational Site Number 1520003

    Viña del Mar

Other trials in Chile

Turkey (Türkiye)8 sites

  • Investigational Site Number 7920004

    Ankara, 06100

  • Investigational Site Number 7920003

    Bursa, 16059

  • Investigational Site Number 7920001

    Istanbul, 34098

  • Investigational Site Number 7920006

    Izmir, 35040

  • Investigational Site Number 7920007

    Izmir, 35110

  • Investigational Site Number 7920008

    Kirikkale, 71450

  • Investigational Site Number 7920002

    Mersin, 33070

  • Investigational Site Number 7920009

    Rize, 53100

Other trials in Turkey (Türkiye)

Poland7 sites

  • Investigational Site Number 6160001

    Bialystok, 15-010

  • Investigational Site Number 6160008

    Bialystok, 15-044

  • Investigational Site Number 6160005

    Bydgoszcz, 85-079

  • Investigational Site Number 6160007

    Krakow, 31-559

  • Investigational Site Number 6160002

    Poznan, 60-693

  • Investigational Site Number 6160006

    Poznan, 60-823

  • Investigational Site Number 6160003

    Żnin, 88-400

Other trials in Poland

Mexico6 sites

  • Investigational Site Number 4840005

    Chihuahua City, 31000

  • Investigational Site Number 4840004

    Durango, 34080

  • Investigational Site Number 4840002

    Guadalajara, 44100

  • Investigational Site Number 4840006

    Monterrey, 64460

  • Investigational Site Number 4840001

    Monterrey, 66465

  • Investigational Site Number 4840003

    Veracruz, 91910

Other trials in Mexico

Argentina5 sites

  • Investigational Site Number 0320001

    Buenos Aires, C1121ABE

  • Investigational Site Number 0320003

    Caba, C1122AAK

  • Investigational Site Number 0320002

    Caba, C1425BEN

  • Investigational Site Number 0320004

    Caba, C1425FVH

  • Investigational Site Number 0320005

    Mendoza, 5500

Other trials in Argentina

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 12-week Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety, and Tolerability of SAR440340 and the Coadministration of SAR440340 and Dupilumab in Patients With Moderate-to-Severe Asthma Who Are Not Well Controlled on Inhaled Corticosteroid (ICS) Plus Long-acting β2 Adrenergic Agonist (LABA) Therapy

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 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.

Read the 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.

Conditions
Asthma
Being tested
SAR440340, Dupilumab, Fluticasone or Fluticasone/salmeterol combination, Placebo for SAR440340, Placebo for dupilumab
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR440340Drug

    Also called REGN3500

    Pharmaceutical form: Solution for Injection, Route of administration: SC

  • DupilumabDrug

    Also called SAR231893 (REGN668)

    Pharmaceutical form: Solution for Injection, Route of administration: SC

  • Fluticasone or Fluticasone/salmeterol combinationDrug

    Pharmaceutical form: Aerosol, dry powder, Route of administration: Inhaled

  • Placebo for SAR440340Drug

    Pharmaceutical form: Solution for Injection, Route of administration: SC

  • Placebo for dupilumabDrug

    Pharmaceutical form: Solution for Injection, Route of administration: SC

Study groups in NCT03387852
Study groupRoleWhat they receive
SAR440340ExperimentalParticipants 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.
Receives: Drug: SAR440340; Drug: Fluticasone or Fluticasone/salmeterol combination; Drug: Placebo for dupilumab
DupilumabActive comparatorParticipants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks.
Receives: Drug: Dupilumab; Drug: Fluticasone or Fluticasone/salmeterol combination; Drug: Placebo for SAR440340
SAR440340 + DupilumabExperimentalParticipants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.
Receives: Drug: SAR440340; Drug: Dupilumab; Drug: Fluticasone or Fluticasone/salmeterol combination
PlaceboPlacebo comparatorParticipants received 2 SC injections of SAR440340 placebo along with 1 SC injection of dupilumab placebo Q2W for 12 weeks.
Receives: Drug: Fluticasone or Fluticasone/salmeterol combination; Drug: Placebo for SAR440340; Drug: Placebo for dupilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Loss of Asthma Control

    An LOAC event during the 12-week treatment period was a deterioration of asthma defined as any of the following: a) 30 percent (%) or greater reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; b) greater than or equal to (>=) 6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; c) increase in inhaled corticosteroid (ICS) >=4 times the last prescribed ICS dose (or >=50% of the prescribed ICS dose at Baseline if background therapy withdrawal completed); d) required use of systemic (oral and/or parenteral) steroid treatment; e) required hospitalization or emergency room visit.

    Measured: From Baseline up to Week 12

Secondary outcomes (2)

  1. Change From Baseline at Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

    FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Pre-bronchodilator FEV1 refers to the spirometry performed after a wash period of bronchodilators (i.e., not earlier than 6 hours) after the last dose of albuterol/salbutamol or levalbuterol/levosalbutamol from a primed meter dose inhaler and withholding the last dose of long-acting β2 adrenergic agonist (LABA) for at least 12 hours, and prior to administration of study drug.

    Measured: Baseline, Week 12

  2. Change From Baseline at Week 12 in Post-bronchodilator Forced Expiratory Volume in 1 Second

    FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Post-bronchodilator FEV1 refers to the spirometry performed within 30 minutes after administration of bronchodilator.

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2018
  2. Study start12 Mar 2018
  3. Primary completion21 Mar 2019
  4. Study completion7 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03387852
Sponsor's protocol ID
ACT15102
Other IDs
2017-003289-29, U1111-1194-2185, 2017
Status last verified
May 2022
First submitted
15 Dec 2017
Last updated
14 Jun 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • 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.

    PubMed 36253275

  • 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.

    PubMed 34706171

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR440340, Dupilumab and Fluticasone or Fluticasone/salmeterol combination in people with Asthma, run by Sanofi at 71 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Ukraine, Russia, Chile, Turkey (Türkiye) and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Loss of Asthma Control (time frame: From Baseline up to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03387852, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.

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