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Chronic Obstructive Pulmonary DiseasePhase 2NCT03546907

Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of SAR440340 (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing SAR440340 in people with Chronic Obstructive Pulmonary Disease, run by Sanofi at 83 sites in 10 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 investigate effects of SAR440340 (anti-interleukin-33 [IL-33] monoclonal antibody [mAb]) compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of COPD (AECOPD) over up to 52 weeks of treatment. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
SAR440340
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
343 participants
Where
83 sitesin 10 countries
Study dates
16 Jul 2018to 21 Feb 2020
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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with a diagnosis of chronic obstructive pulmonary disease (COPD) for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition).
  • Participants with moderate-to-severe COPD (post-bronchodilator forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] less than [<] 70 percent (%) and post-bronchodilator FEV1% predicted <80%, but greater than equal to [>=] 30%).
  • Participants with COPD assessment test (CAT) score >=10 at Screening.
  • Participants with reported history of signs and symptoms of chronic bronchitis (chronic productive cough for 3 months in the year up to screening in a participant in whom other causes of chronic cough [e.g., gastroesophageal reflux, chronic rhinosinusitis, bronchiectasis] had been excluded).
  • Participants with a documented history (e.g., medical record verification) of >=2 moderate exacerbations or >=1 severe exacerbation within the year prior to screening. A moderate exacerbation was defined as an acute exacerbation of COPD (AECOPD) requiring systemic corticosteroids (oral, intravenous, or intramuscular) and/or treatment with antibiotics (however, use of antibiotics alone does not qualify as a "moderate exacerbation" unless documentation was available that use of antibiotics was necessary for treatment of worsening symptoms of COPD). A severe exacerbation was defined as an AECOPD that required a hospitalization.
  • Participants with standard of care background therapy, for 3 months and at a stable dose for at least 1 month, including either:
Show all 10Show fewer
  • Double therapy: Long acting beta agonist (LABA) + Long acting muscarinic agonist (LAMA) or inhaled corticosteroid (ICS) + LABA or ICS + LAMA.
  • or
  • Triple therapy: LABA + LAMA + ICS.
  • Current or former smokers with a smoking history of >=10 packs/year.

Who cannot join

  • Concomitant severe diseases or diseases for which the use of ICS (e.g., active pulmonary tuberculosis, etc.) or LABA were contraindicated (e.g., diagnosis of a history of significant cardiovascular diseases, insulin-dependent diabetes mellitus, hyperthyroidism, thyrotoxicosis, pheochromocytoma, hypokalemia).
  • Use of injectable glucocorticosteroids or oral systemic glucocorticosteroids within previous 1 month or more than 4 courses of intravenous glucocorticosteroids within the previous 6 months.
  • Participants with bronchial thermoplasty procedure (up to 3 years prior to Visit 1).
  • A current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines.
  • Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, eosinophilic granulomatosis with polyangiitis, significant sleep apnea on Bilevel Positive Airway Pressure, etc.) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
  • Diagnosis of α-1 anti-trypsin deficiency.
Show all 11Show fewer
  • Advanced COPD with need for chronic (greater than [>] 15 hours/day) oxygen support.
  • Participant with a moderate or severe acute exacerbation of COPD event within previous 4 weeks.
  • A participant who has experienced an upper or lower respiratory tract infection within previous 4 weeks.
  • Prior history of or planned pneumonectomy or lung volume reduction surgery.
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

83 sites in 10 countries.

83 sites in 10 countries

United States16 sites

  • Investigational Site Number 8400019

    Chapel Hill, North Carolina, 27517

  • Investigational Site Number 8400012

    Columbia, Maryland, 21044

  • Investigational Site Number 8400008

    Greenfield, Wisconsin, 53228

  • Investigational Site Number 8400013

    Jacksonville, Florida, 32216

  • Investigational Site Number 8400005

    Jamaica, New York, 11418-2619

  • Investigational Site Number 8400002

    Los Angeles, California, 90025

  • Investigational Site Number 8400001

    Medford, Oregon, 97504

  • Investigational Site Number 8400011

    Minneapolis, Minnesota, 55407

  • Investigational Site Number 8400016

    North Dartmouth, Massachusetts, 02747

  • Investigational Site Number 8400009

    Philadelphia, Pennsylvania, 19140

  • Investigational Site Number 8400007

    Plano, Texas, 75093

  • Investigational Site Number 8400004

    Raleigh, North Carolina, 27607

  • Investigational Site Number 8400003

    Riverside, California, 92506

  • Investigational Site Number 8400006

    Rolling Hills Estates, California, 90274

  • Investigational Site Number 8400020

    South Dartmouth, Massachusetts, 02747

  • Investigational Site Number 8400015

    Westminster, California, 92683

Other trials in United States

Ukraine10 sites

  • Investigational Site Number 8040008

    Chernivtsi, 58001

  • Investigational Site Number 8040012

    Ivano-Frankivsk, 76000

  • Investigational Site Number 8040004

    Ivano-Frankivsk, 76018

  • Investigational Site Number 8040002

    Kharkiv, 61039

  • 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

Canada9 sites

  • Investigational Site Number 1240002

    Burlington, L7N 3V2

  • Investigational Site Number 1240009

    Hamilton, L8N 4A6

  • Investigational Site Number 1240003

    Montreal, H2X 3E4

  • Investigational Site Number 1240001

    Montreal, H4A 3J1

  • Investigational Site Number 1240005

    Québec, G1V 4G5

  • Investigational Site Number 1240006

    Saint-Charles-Borromée, J6E 2B4

  • Investigational Site Number 1240008

    Trois-Rivières, G8T 7A1

  • Investigational Site Number 1240007

    Vancouver, V6Z 1Y6

  • Investigational Site Number 1240004

    Victoriaville, G6P 6P6

Other trials in Canada

Poland9 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 6160009

    Grudziądz, 86-300

  • Investigational Site Number 6160007

    Krakow, 31-559

  • Investigational Site Number 6160002

    Poznan, 60-693

  • Investigational Site Number 6160006

    Poznan, 60-823

  • Investigational Site Number 6160010

    Rzeszów, 35-205

  • Investigational Site Number 6160003

    Żnin, 88-400

Other trials in Poland

Russia9 sites

  • Investigational Site Number 6430003

    Moscow, 109240

  • Investigational Site Number 6430001

    Moscow, 109544

  • Investigational Site Number 6430005

    Moscow, 115280

  • Investigational Site Number 6430002

    Moscow, 117546

  • 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

Argentina6 sites

  • Investigational Site Number 0320001

    Buenos Aires, C1121ABE

  • Investigational Site Number 0320005

    Caba, C1414AIF

  • Investigational Site Number 0320002

    Caba, C1425BEN

  • Investigational Site Number 0320004

    Caba, C1425FVH

  • Investigational Site Number 0320006

    Quilmes, B1878FNR

  • Investigational Site Number 0320003

    Rosario, 2000

Other trials in Argentina

Australia6 sites

  • Investigational Site Number 0360005

    Bedford Park, 5042

  • Investigational Site Number 0360002

    Chermside, 4032

  • Investigational Site Number 0360004

    Clayton, 3168

  • Investigational Site Number 0360003

    Frankston, 3199

  • Investigational Site Number 0360006

    Kent Town, 5067

  • Investigational Site Number 0360001

    Murdoch, 6150

Other trials in Australia

Chile6 sites

  • Investigational Site Number 1520002

    Quillota, 2260877

  • Investigational Site Number 1520001

    Santiago, 7500692

  • Investigational Site Number 1520007

    Santiago, 8330336

  • Investigational Site Number 1520004

    Santiago, 8910131

  • Investigational Site Number 1520005

    Talca

  • Investigational Site Number 1520003

    Talcahuano

Other trials in Chile

Germany6 sites

  • Investigational Site Number 2760006

    Berlin, 10787

  • Investigational Site Number 2760001

    Großhansdorf, 22927

  • Investigational Site Number 2760002

    Hamburg, 20354

  • Investigational Site Number 2760007

    Koblenz, 56068

  • Investigational Site Number 2760004

    München, 81377

  • Investigational Site Number 2760005

    Rüdersdorf Bei Berlin, 15562

Other trials in Germany

Turkey (Türkiye)6 sites

  • Investigational Site Number 7920004

    Ankara, 06100

  • 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

Other trials in Turkey (Türkiye)

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of SAR440340, in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Primary Objective:

To investigate effects of SAR440340 (anti-interleukin-33 [IL-33] monoclonal antibody [mAb]) compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of COPD (AECOPD) over up to 52 weeks of treatment.

Read more
  • Moderate exacerbations were recorded by the Investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics.
  • Severe exacerbations were recorded by the Investigator and defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death.

Secondary Objectives:

To investigate effects of SAR440340 compared with placebo, on improving respiratory function, as assessed by pre-bronchodilator forced exploratory volume in 1 second (FEV1).

To evaluate effects of SAR440340 compared with placebo, on post-bronchodilator FEV1.

To evaluate effects of SAR440340 compared with placebo, on duration from baseline to first moderate or severe AECOPD event.

To evaluate effects of SAR440340 compared with placebo, on safety and tolerability.

Read the detailed description

Study participation for each participant were up to a total of 46 weeks to 76 weeks including up to 10 days to 4 weeks of screening, 24-to-52 week treatment period on investigational medical product (IMP), and 20 weeks of post IMP treatment period.

Being tested
SAR440340, Placebo, Any Inhaled Corticosteroids as prescribed by treating physician as standard of care, Any Long Acting Beta Agonist as prescribed by treating physician as standard of care, Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

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

  • SAR440340Drug

    Also called Itepekimab, REGN3500

    Pharmaceutical form: Solution for injection; Route of administration: SC

  • PlaceboDrug

    Pharmaceutical form: Solution for injection; Route of administration: SC

  • Any Inhaled Corticosteroids as prescribed by treating physician as standard of careDrug

    Pharmaceutical form: Aerosol or Dry Powder inhaler Route of administration: Inhaled

  • Any Long Acting Beta Agonist as prescribed by treating physician as standard of careDrug

    Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled

  • Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of careDrug

    Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled

  • Any short-acting β agonist as prescribed by treating physician as standard of careDrug

    Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: inhaled

Study groups in NCT03546907
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received placebo matched to SAR440340 administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W). Participants were treated for a minimum of 24 weeks and up to a maximum of 52 weeks (last dose administered at Week 50, End of Treatment (EOT) visit occurred 2 weeks after last administration of IMP i.e., at Week 52).
Receives: Drug: Placebo; Drug: Any Inhaled Corticosteroids as prescribed by treating physician as standard of care; Drug: Any Long Acting Beta Agonist as prescribed by treating physician as standard of care; Drug: Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care; Drug: Any short-acting β agonist as prescribed by treating physician as standard of care
SAR440340ExperimentalParticipants received SAR440340 300 milligrams (mg) administered as 2 SC injections Q2W. Participants were treated for a minimum of 24 weeks and up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of IMP i.e., at Week 52).
Receives: Drug: SAR440340; Drug: Any Inhaled Corticosteroids as prescribed by treating physician as standard of care; Drug: Any Long Acting Beta Agonist as prescribed by treating physician as standard of care; Drug: Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care; Drug: Any short-acting β agonist as prescribed by treating physician as standard of care

What is being measured

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

  1. Annualized Rate of Moderate to Severe Acute Exacerbation Events in Chronic Obstructive Pulmonary Disease (AECOPD) Participants

    Moderate exacerbations events were recorded by the investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations events were defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.

    Measured: From Baseline up to Week 52

Secondary outcomes (3)

  1. Average Change in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Week 16 Through Week 24

    FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. A mixed-effect model with repeated measures (MMRM) was first used to model the change from baseline at each post randomization timepoint up to Week 24, then the predicted values of Week 16 to Week 24 were averaged to provide an overall assessment of change from baseline in FEV1.

    Measured: From Baseline to Week 16 through Week 24

  2. Change From Baseline in Post-bronchodilator Forced Expiratory Volume (FEV1) in 1 Second at Week 24

    FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-bronchodilator FEV1 referred to the spirometry performed within 30 minutes after administration of bronchodilator (4 puffs of salbutamol/albuterol [100 micrograms {mcg}] or ipratropium bromide [20 mcg]).

    Measured: Baseline, Week 24

  3. Time to First Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

    The time to first moderate or severe exacerbation was defined as onset date of first moderate or severe AECOPD minus randomization date + 1. The median time to first severe exacerbation was derived from Kaplan-Meier estimates. Moderate exacerbations events were recorded by the investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations events were defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death.

    Measured: From Baseline up to 52 weeks

Timeline

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

  1. First posted6 Jun 2018
  2. Study start16 Jul 2018
  3. Primary completion3 Oct 2019
  4. Study completion21 Feb 2020

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
343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03546907
Sponsor's protocol ID
ACT15104
Other IDs
2017-003290-34, U1111-1194-2134, 2017
Status last verified
Oct 2022
First submitted
17 May 2018
Last updated
22 Nov 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

  • Rabe KF, Celli BR, Wechsler ME, Abdulai RM, Luo X, Boomsma MM, Staudinger H, Horowitz JE, Baras A, Ferreira MA, Ruddy MK, Nivens MC, Amin N, Weinreich DM, Yancopoulos GD, Goulaouic H. Safety and efficacy of itepekimab in patients with moderate-to-severe COPD: a genetic association study and randomised, double-blind, phase 2a trial. Lancet Respir Med. 2021 Nov;9(11):1288-1298. doi: 10.1016/S2213-2600(21)00167-3. Epub 2021 Jul 21.

    PubMed 34302758

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR440340 in people with Chronic Obstructive Pulmonary Disease, run by Sanofi at 83 sites in 10 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 10 inclusion and 11 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 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Ukraine, Canada, Poland, Russia and 5 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 22 Nov 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?

Annualized Rate of Moderate to Severe Acute Exacerbation Events in Chronic Obstructive Pulmonary Disease (AECOPD) Participants (time frame: From Baseline up to Week 52). 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 NCT03546907, which also lists 1 linked publication.

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 22 Nov 2022.

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