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Idiopathic Pulmonary FibrosisPhase 2ESTAIRNCT02345070

Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis

A Phase 2 study testing SAR156597 in people with Idiopathic Pulmonary Fibrosis, run by Sanofi at 101 sites in 19 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, in comparison with placebo, the efficacy of 2 dose levels/regimens of SAR156597 administered subcutaneously during 52 weeks on lung function of participants with Idiopathic Pulmonary Fibrosis (IPF). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
SAR156597
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
327 participants
Where
101 sitesin 19 countries
Study dates
1 May 2015to 14 Aug 2017
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult male or female participants.
  • Documented diagnosis of IPF according to the current 2011 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ American Latin Thoracic Association (ATS/ERS/JRS/ALAT) guidelines.
  • Signed written informed consent.

Who cannot join

  • Age less than or equal to 40 years.
  • IPF disease diagnosis greater than 5 years.
  • Forced vital capacity (FVC) less than (<) 40 percent (%) of predicted value.
  • Carbon monoxide diffusing lung capacity (DLCO) corrected for hemoglobin <30% of predicted value.
  • Severe chronic obstructive bronchitis as characterized by forced expiratory volume in 1 second /forced vital capacity (FEV1/FVC) <0.70.
  • Need for 24 hours of oxygen therapy or oxygen saturation <88% after 10 minutes breathing ambient air at rest.
Show all 16Show fewer
  • Known diagnosis of significant respiratory disorders other than IPF.
  • Pulmonary artery hypertension requiring a specific treatment.
  • Currently listed and/or anticipated for lung transplantation within the next 6 months (on an active list).
  • History of vasculitis or connective tissue disorders.
  • Known human immunodeficiency virus or chronic viral hepatitis.
  • Participants with active tuberculosis or incompletely treated latent tuberculosis infection.
  • Use of any cytotoxic/immunosuppressive agent including but not limited to azathioprine, cyclophosphamide, methotrexate, and cyclosporine within 4 weeks prior to screening.
  • Use of any cytokine modulators (etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab, rituximab) within 12 weeks or 5 half-lives of screening (24 weeks for rituximab and 24 months for alefacept).
  • Use of any investigational drug within 1 month of screening, or 5 half-lives, if known ( whichever was longer), or within 12 weeks for stem cell therapy.
  • 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

101 sites in 19 countries.

101 sites in 19 countries

United States18 sites

  • Investigational Site Number 840017

    Atlanta, Georgia, 30322

  • Investigational Site Number 840026

    Chesterfield, Missouri, 63017

  • Investigational Site Number 840011

    Dallas, Texas, 75390

  • Investigational Site Number 840008

    Decatur, Georgia, 30033

  • Investigational Site Number 840024

    Everett, Washington, 98208

  • Investigational Site Number 840020

    Jacksonville, Florida, 32209

  • Investigational Site Number 840015

    Jamaica, New York, 11435

  • Investigational Site Number 840001

    Lebanon, New Hampshire, 03756

  • Investigational Site Number 840010

    Louisville, Kentucky, 40218

  • Investigational Site Number 840022

    Loxahatchee Groves, Florida, 33470

  • Investigational Site Number 840023

    Mineola, New York, 11501

  • Investigational Site Number 840009

    Minneapolis, Minnesota, 55455

  • Investigational Site Number 840012

    New York, New York, 10016

  • Investigational Site Number 840014

    Philadelphia, Pennsylvania, 19104

  • Investigational Site Number 840003

    Phoenix, Arizona, 85006

  • Investigational Site Number 840006

    Rochester, Minnesota, 55905

  • Investigational Site Number 840013

    Stony Brook, New York, 11794-8121

  • Investigational Site Number 840002

    Summit, New Jersey, 07901

Other trials in United States

France9 sites

  • Investigational Site Number 250007

    Bobigny

  • Investigational Site Number 250002

    Lille, 59037

  • Investigational Site Number 250001

    Lyon, 69394

  • Investigational Site Number 250009

    Marseille, 13015

  • Investigational Site Number 250005

    Montpellier, 34295

  • Investigational Site Number 250004

    Nice, 6002

  • Investigational Site Number 250006

    Paris, 75018

  • Investigational Site Number 250008

    Toulouse, 31059

  • Investigational Site Number 250003

    Tours

Other trials in France

Spain7 sites

  • Investigational Site Number 724003

    Barcelona, 08035

  • Investigational Site Number 724002

    Barcelona, 08036

  • Investigational Site Number 724001

    L'Hospitalet de Llobregat, 08907

  • Investigational Site Number 724004

    Lugo, 27003

  • Investigational Site Number 724006

    Majadahonda, 28222

  • Investigational Site Number 724005

    Palma de Mallorca, 07120

  • Investigational Site Number 724007

    Sabadell, 08208

Other trials in Spain

Argentina6 sites

  • Investigational Site Number 032009

    Caba, C1414AIF

  • Investigational Site Number 032005

    Caba, C1425FVH

  • Investigational Site Number 032001

    La Plata, B1900DXM

  • Investigational Site Number 032004

    Mendoza, 5500

  • Investigational Site Number 032002

    San Miguel de Tucumán, T4000IAR

  • Investigational Site Number 032007

    Vicente López, 1602

Other trials in Argentina

Chile6 sites

  • Investigational Site Number 152003

    Quillota, 2260877

  • Investigational Site Number 152001

    Santiago, 750-0691

  • Investigational Site Number 152004

    Santiago, 7500698

  • Investigational Site Number 152006

    Santiago, 8380456

  • Investigational Site Number 152002

    Talca, 3460001

  • Investigational Site Number 152007

    Viña del Mar

Other trials in Chile

Italy6 sites

  • Investigational Site Number 380003

    Catania, 95123

  • Investigational Site Number 380001

    Forlì, 47121

  • Investigational Site Number 380005

    Milan, 20123

  • Investigational Site Number 380002

    Orbassano, 10043

  • Investigational Site Number 380006

    Pisa, 56124

  • Investigational Site Number 380004

    Siena, 53100

Other trials in Italy

South Korea6 sites

  • Investigational Site Number 410005

    Bucheon-si, 14584

  • Investigational Site Number 410001

    Incheon, 21565

  • Investigational Site Number 410006

    Seongnam, 463-707

  • Investigational Site Number 410002

    Seoul, 02841

  • Investigational Site Number 410003

    Seoul, 110-744

  • Investigational Site Number 410004

    Seoul

Other trials in South Korea

Turkey (Türkiye)6 sites

  • Investigational Site Number 792005

    Ankara, 06620

  • Investigational Site Number 792006

    Istanbul, 34098

  • Investigational Site Number 792001

    Istanbul, 34111

  • Investigational Site Number 792004

    Istanbul, 34390

  • Investigational Site Number 792003

    Istanbul, 34844

  • Investigational Site Number 792002

    Izmir, 35100

Other trials in Turkey (Türkiye)

Australia5 sites

  • Investigational Site Number 036005

    Camperdown, 2050

  • Investigational Site Number 036004

    Darlinghurst, 2010

  • Investigational Site Number 036002

    Frankston, 3199

  • Investigational Site Number 036003

    Murdoch, 6150

  • Investigational Site Number 036001

    Nundah, 4012

Other trials in Australia

Germany5 sites

  • Investigational Site Number 276003

    Coswig, 01640

  • Investigational Site Number 276002

    Donaustauf, 93093

  • Investigational Site Number 276004

    Giessen, 35392

  • Investigational Site Number 276005

    Hanover, 30625

  • Investigational Site Number 276001

    Heidelberg, 69126

Other trials in Germany

Israel5 sites

  • Investigational Site Number 376001

    Haifa, 34362

  • Investigational Site Number 376004

    Kfar Saba, 44281

  • Investigational Site Number 376002

    Petah Tikva, 49100

  • Investigational Site Number 376005

    Rehovot, 76100

  • Investigational Site Number 376003

    Tel HaShomer, 52621

Other trials in Israel

Czechia4 sites

  • Investigational Site Number 203002

    Hradec Králové, 50005

  • Investigational Site Number 203004

    Olomouc, 77900

  • Investigational Site Number 203003

    Prague, 12808

  • Investigational Site Number 203001

    Prague, 14059

Other trials in Czechia

Mexico4 sites

  • Investigational Site Number 484002

    Mexico City, 14050

  • Investigational Site Number 484001

    Monterrey, 64460

  • Investigational Site Number 484005

    Monterrey, 66465

  • Investigational Site Number 484003

    San Juan del Río, 76800

Other trials in Mexico

United Kingdom4 sites

  • Investigational Site Number 826002

    Cambridge, CB23 3RE

  • Investigational Site Number 826003

    Exeter, EX2 5DW

  • Investigational Site Number 826004

    Leicester, LE3 9QP

  • Investigational Site Number 826001

    London, SE1 7EH

Other trials in United Kingdom

Colombia3 sites

  • Investigational Site Number 170004

    Armenia, 630004

  • Investigational Site Number 170001

    Bogotá, 110121

  • Investigational Site Number 170005

    Cali

Other trials in Colombia

Canada2 sites

  • Investigational Site Number 124003

    Toronto, M5G 2N2

  • Investigational Site Number 124002

    Vancouver, V5Z 1M9

Other trials in Canada

Denmark2 sites

  • Investigational Site Number 208002

    Aarhus C, 8000

  • Investigational Site Number 208001

    Hellerup, 2900

Other trials in Denmark

Portugal2 sites

  • Investigational Site Number 620003

    Porto, 4200-319

  • Investigational Site Number 620004

    Vila Nova de Gaia, 4400

Other trials in Portugal

Greece1 site

  • Investigational Site Number 300001

    Heraklion, 71110

Other trials in Greece

About this study

Official title: Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study

Primary Objective:

To evaluate, in comparison with placebo, the efficacy of 2 dose levels/regimens of SAR156597 administered subcutaneously during 52 weeks on lung function of participants with Idiopathic Pulmonary Fibrosis (IPF).

Secondary Objectives:

To evaluate the efficacy of 2 dose levels/regimens of SAR156597 compared to placebo on IPF disease progression.

To evaluate the safety of 2 dose levels/regimens of SAR156597 compared to placebo in participants with IPF.

Read the detailed description

The total study duration of study was expected up to 68 weeks (screening period of 4 weeks, treatment period of 52 weeks, and 12 weeks of follow up).

Being tested
SAR156597, placebo
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

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

  • SAR156597Drug

    Pharmaceutical form: solution for injection Route of administration: subcutaneous

  • placeboDrug

    Pharmaceutical form: solution for injection Route of administration: subcutaneous

Study groups in NCT02345070
Study groupRoleWhat they receive
Placebo qwPlacebo comparatorParticipants received one injection of placebo (matched to SAR156597) subcutaneously once every week (qw) for 52 weeks.
Receives: Drug: placebo
SAR156597 200 mg q2wExperimentalParticipants received one injection of SAR156597 200 mg subcutaneously once every 2 weeks (q2w) alternating with placebo (matched to SAR156597) for 52 weeks.
Receives: Drug: SAR156597; Drug: placebo
SAR156597 200 mg qwExperimentalParticipants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
Receives: Drug: SAR156597

What is being measured

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

  1. Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52

    FVC is a standard pulmonary function parameter measured by spirometry and used to quantify respiratory capacity (inspiration and expiration). It is a widely used objective measure of disease status in participants with Idiopathic Pulmonary Fibrosis (IPF). The primary variable was recorded as percent (%) of predicted value, which takes into account the height, gender, and age of the participant. The outcome measure measured the change in lung function from baseline at week 52.

    Measured: Baseline, Week 52

Secondary outcomes (2)

  1. Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52

    Disease progression was defined as the time from randomization to the first occurrence of any of the following events: decrease in absolute percent predicted FVC greater than or equal to (>=) 10%, decrease in absolute percent predicted Carbon monoxide diffusing lung capacity >=15%, lung transplant, or death. The median time to disease progression was not estimated because the number of occurrence of events was too low in the SAR156597 200 mg arms.

    Measured: From randomization to disease progression (up to Week 52)

  2. Time to Event: Kaplan-Meier Estimates of Probability of All Cause Mortality (Deaths) at Week 52

    All-cause mortality was considered for this outcome measure which was defined as the time from randomization to the date of death. The median time to event was not estimated because the number of all cause mortality was too low in the SAR156597 200 mg arms.

    Measured: From randomization up to Week 52

Timeline

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

  1. First posted26 Jan 2015 (estimated)
  2. Study start1 May 2015
  3. Primary completion22 May 2017
  4. Study completion14 Aug 2017

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
327 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02345070
Sponsor's protocol ID
DRI11772
Other IDs
2014-003933-24, U1111-1154-6083, 2014
Acronym
ESTAIR
Status last verified
Mar 2022
First submitted
19 Jan 2015
Last updated
24 Mar 2022
Data monitoring committee
Yes
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR156597 in people with Idiopathic Pulmonary Fibrosis, run by Sanofi at 101 sites in 19 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 3 inclusion and 16 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 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States, France, Spain, Argentina, Chile and 14 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 26 May 2020). 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?

Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52 (time frame: Baseline, 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 NCT02345070.

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 24 Mar 2022.

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