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

Idiopathic Pulmonary Fibrosis Clinical Trial

— ESTAIR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345070
• Other study ID #: DRI11772
• Secondary ID: 2014-003933-24U1
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2015
• Est. completion date: August 14, 2017

Study information

• Verified date: March 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: August 14, 2017
• Est. primary completion date: May 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion criteria :

• 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.

Exclusion criteria:

• 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.
• 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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• SAR156597
Pharmaceutical form: solution for injection Route of administration: subcutaneous
• placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Locations

Country	Name	City	State
Argentina	Investigational Site Number 032005	Caba
Argentina	Investigational Site Number 032009	Caba
Argentina	Investigational Site Number 032001	La Plata
Argentina	Investigational Site Number 032004	Mendoza
Argentina	Investigational Site Number 032002	San Miguel De Tucumán
Argentina	Investigational Site Number 032007	Vicente Lopez
Australia	Investigational Site Number 036005	Camperdown
Australia	Investigational Site Number 036004	Darlinghurst
Australia	Investigational Site Number 036002	Frankston
Australia	Investigational Site Number 036003	Murdoch
Australia	Investigational Site Number 036001	Nundah
Canada	Investigational Site Number 124003	Toronto
Canada	Investigational Site Number 124002	Vancouver
Chile	Investigational Site Number 152003	Quillota
Chile	Investigational Site Number 152001	Santiago
Chile	Investigational Site Number 152004	Santiago
Chile	Investigational Site Number 152006	Santiago
Chile	Investigational Site Number 152002	Talca
Chile	Investigational Site Number 152007	Viña Del Mar
Colombia	Investigational Site Number 170004	Armenia
Colombia	Investigational Site Number 170001	Bogota
Colombia	Investigational Site Number 170005	Cali
Czechia	Investigational Site Number 203002	Hradec Kralove
Czechia	Investigational Site Number 203004	Olomouc
Czechia	Investigational Site Number 203003	Praha 2
Czechia	Investigational Site Number 203001	Praha 4
Denmark	Investigational Site Number 208002	Aarhus C
Denmark	Investigational Site Number 208001	Hellerup
France	Investigational Site Number 250007	Bobigny
France	Investigational Site Number 250002	Lille Cedex
France	Investigational Site Number 250001	Lyon
France	Investigational Site Number 250009	Marseille
France	Investigational Site Number 250005	Montpellier
France	Investigational Site Number 250004	Nice
France	Investigational Site Number 250006	Paris
France	Investigational Site Number 250008	Toulouse
France	Investigational Site Number 250003	Tours
Germany	Investigational Site Number 276003	Coswig
Germany	Investigational Site Number 276002	Donaustauf
Germany	Investigational Site Number 276004	Gießen
Germany	Investigational Site Number 276005	Hannover
Germany	Investigational Site Number 276001	Heidelberg
Greece	Investigational Site Number 300001	Heraklion
Israel	Investigational Site Number 376001	Haifa
Israel	Investigational Site Number 376004	Kfar Saba
Israel	Investigational Site Number 376002	Petah-Tikva
Israel	Investigational Site Number 376005	Rehovot
Israel	Investigational Site Number 376003	Tel Hashomer
Italy	Investigational Site Number 380003	Catania
Italy	Investigational Site Number 380001	Forlì
Italy	Investigational Site Number 380005	Milano
Italy	Investigational Site Number 380002	Orbassano
Italy	Investigational Site Number 380006	Pisa
Italy	Investigational Site Number 380004	Siena
Korea, Republic of	Investigational Site Number 410005	Bucheon-Si
Korea, Republic of	Investigational Site Number 410001	Incheon
Korea, Republic of	Investigational Site Number 410006	Seongnam
Korea, Republic of	Investigational Site Number 410002	Seoul
Korea, Republic of	Investigational Site Number 410003	Seoul
Korea, Republic of	Investigational Site Number 410004	Seoul
Mexico	Investigational Site Number 484002	Mexico City
Mexico	Investigational Site Number 484001	Monterrey
Mexico	Investigational Site Number 484005	Monterrey
Mexico	Investigational Site Number 484003	San Juan Del Rio
Portugal	Investigational Site Number 620003	Porto
Portugal	Investigational Site Number 620004	Vila Nova De Gaia
Spain	Investigational Site Number 724002	Barcelona
Spain	Investigational Site Number 724003	Barcelona
Spain	Investigational Site Number 724001	Hospitalet De Llobregat
Spain	Investigational Site Number 724004	Lugo
Spain	Investigational Site Number 724006	Majadahonda
Spain	Investigational Site Number 724005	Palma De Mallorca
Spain	Investigational Site Number 724007	Sabadell
Turkey	Investigational Site Number 792005	Ankara
Turkey	Investigational Site Number 792001	Istanbul
Turkey	Investigational Site Number 792003	Istanbul
Turkey	Investigational Site Number 792004	Istanbul
Turkey	Investigational Site Number 792006	Istanbul
Turkey	Investigational Site Number 792002	Izmir
United Kingdom	Investigational Site Number 826002	Cambridge
United Kingdom	Investigational Site Number 826003	Exeter
United Kingdom	Investigational Site Number 826004	Leicester
United Kingdom	Investigational Site Number 826001	London
United States	Investigational Site Number 840017	Atlanta	Georgia
United States	Investigational Site Number 840026	Chesterfield	Missouri
United States	Investigational Site Number 840011	Dallas	Texas
United States	Investigational Site Number 840008	Decatur	Georgia
United States	Investigational Site Number 840024	Everett	Washington
United States	Investigational Site Number 840020	Jacksonville	Florida
United States	Investigational Site Number 840015	Jamaica	New York
United States	Investigational Site Number 840001	Lebanon	New Hampshire
United States	Investigational Site Number 840010	Louisville	Kentucky
United States	Investigational Site Number 840022	Loxahatchee Groves	Florida
United States	Investigational Site Number 840023	Mineola	New York
United States	Investigational Site Number 840009	Minneapolis	Minnesota
United States	Investigational Site Number 840012	New York	New York
United States	Investigational Site Number 840014	Philadelphia	Pennsylvania
United States	Investigational Site Number 840003	Phoenix	Arizona
United States	Investigational Site Number 840006	Rochester	Minnesota
United States	Investigational Site Number 840013	Stony Brook	New York
United States	Investigational Site Number 840002	Summit	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Chile,  Colombia,  Czechia,  Denmark,  France,  Germany,  Greece,  Israel,  Italy,  Korea, Republic of,  Mexico,  Portugal,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 52
Secondary	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.	From randomization to disease progression (up to Week 52)
Secondary	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.	From randomization up to Week 52