Clinical trial NCT02345070: Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2015-01-26
Enrollment: 327
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52
timeFrame: Baseline, Week 52
Secondary outcomes:
measure: Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52
timeFrame: From randomization to disease progression (up to Week 52)
measure: Time to Event: Kaplan-Meier Estimates of Probability of All Cause Mortality (Deaths) at Week 52
timeFrame: From randomization up to Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigational Site Number 840003
state: Arizona
city: Jacksonville
country: United States
facility: Investigational Site Number 840020
state: Florida
city: Loxahatchee Groves
country: United States
facility: Investigational Site Number 840022
state: Florida
city: Atlanta
country: United States
facility: Investigational Site Number 840017
state: Georgia
city: Decatur
country: United States
facility: Investigational Site Number 840008
state: Georgia
city: Louisville
country: United States
facility: Investigational Site Number 840010
state: Kentucky
city: Minneapolis
country: United States
facility: Investigational Site Number 840009
state: Minnesota
city: Rochester
country: United States
facility: Investigational Site Number 840006
state: Minnesota
city: Chesterfield
country: United States
facility: Investigational Site Number 840026
state: Missouri
city: Lebanon
country: United States
facility: Investigational Site Number 840001
state: New Hampshire
city: Summit
country: United States
facility: Investigational Site Number 840002
state: New Jersey
city: Jamaica
country: United States
facility: Investigational Site Number 840015
state: New York
city: Mineola
country: United States
facility: Investigational Site Number 840023
state: New York
city: New York
country: United States
facility: Investigational Site Number 840012
state: New York
city: Stony Brook
country: United States
facility: Investigational Site Number 840013
state: New York
city: Philadelphia
country: United States
facility: Investigational Site Number 840014
state: Pennsylvania
city: Dallas
country: United States
facility: Investigational Site Number 840011
state: Texas
city: Everett
country: United States
facility: Investigational Site Number 840024
state: Washington
city: Caba
country: Argentina
facility: Investigational Site Number 032009
city: Caba
country: Argentina
facility: Investigational Site Number 032005
city: La Plata
country: Argentina
facility: Investigational Site Number 032001
city: Mendoza
country: Argentina
facility: Investigational Site Number 032004
city: San Miguel De Tucumán
country: Argentina
facility: Investigational Site Number 032002
city: Vicente Lopez
country: Argentina
facility: Investigational Site Number 032007
city: Camperdown
country: Australia
facility: Investigational Site Number 036005
city: Darlinghurst
country: Australia
facility: Investigational Site Number 036004
city: Frankston
country: Australia
facility: Investigational Site Number 036002
city: Murdoch
country: Australia
facility: Investigational Site Number 036003
city: Nundah
country: Australia
facility: Investigational Site Number 036001
city: Toronto
country: Canada
facility: Investigational Site Number 124003
city: Vancouver
country: Canada
facility: Investigational Site Number 124002
city: Quillota
country: Chile
facility: Investigational Site Number 152003
city: Santiago
country: Chile
facility: Investigational Site Number 152001
city: Santiago
country: Chile
facility: Investigational Site Number 152004
city: Santiago
country: Chile
facility: Investigational Site Number 152006
city: Talca
country: Chile
facility: Investigational Site Number 152002
city: Viña Del Mar
country: Chile
facility: Investigational Site Number 152007
city: Armenia
country: Colombia
facility: Investigational Site Number 170004
city: Bogota
country: Colombia
facility: Investigational Site Number 170001
city: Cali
country: Colombia
facility: Investigational Site Number 170005
city: Hradec Kralove
country: Czechia
facility: Investigational Site Number 203002
city: Olomouc
country: Czechia
facility: Investigational Site Number 203004
city: Praha 2
country: Czechia
facility: Investigational Site Number 203003
city: Praha 4
country: Czechia
facility: Investigational Site Number 203001
city: Aarhus C
country: Denmark
facility: Investigational Site Number 208002
city: Hellerup
country: Denmark
facility: Investigational Site Number 208001
city: Bobigny
country: France
facility: Investigational Site Number 250007
city: Lille Cedex
country: France
facility: Investigational Site Number 250002
city: Lyon
country: France
facility: Investigational Site Number 250001
city: Marseille
country: France
facility: Investigational Site Number 250009
city: Montpellier
country: France
facility: Investigational Site Number 250005
city: Nice
country: France
facility: Investigational Site Number 250004
city: Paris
country: France
facility: Investigational Site Number 250006
city: Toulouse
country: France
facility: Investigational Site Number 250008
city: Tours
country: France
facility: Investigational Site Number 250003
city: Coswig
country: Germany
facility: Investigational Site Number 276003
city: Donaustauf
country: Germany
facility: Investigational Site Number 276002
city: Gießen
country: Germany
facility: Investigational Site Number 276004
city: Hannover
country: Germany
facility: Investigational Site Number 276005
city: Heidelberg
country: Germany
facility: Investigational Site Number 276001
city: Heraklion
country: Greece
facility: Investigational Site Number 300001
city: Haifa
country: Israel
facility: Investigational Site Number 376001
city: Kfar Saba
country: Israel
facility: Investigational Site Number 376004
city: Petah-Tikva
country: Israel
facility: Investigational Site Number 376002
city: Rehovot
country: Israel
facility: Investigational Site Number 376005
city: Tel Hashomer
country: Israel
facility: Investigational Site Number 376003
city: Catania
country: Italy
facility: Investigational Site Number 380003
city: Forlì
country: Italy
facility: Investigational Site Number 380001
city: Milano
country: Italy
facility: Investigational Site Number 380005
city: Orbassano
country: Italy
facility: Investigational Site Number 380002
city: Pisa
country: Italy
facility: Investigational Site Number 380006
city: Siena
country: Italy
facility: Investigational Site Number 380004
city: Bucheon-Si
country: Korea, Republic of
facility: Investigational Site Number 410005
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number 410001
city: Seongnam
country: Korea, Republic of
facility: Investigational Site Number 410006
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410002
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410003
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410004
city: Mexico City
country: Mexico
facility: Investigational Site Number 484002
city: Monterrey
country: Mexico
facility: Investigational Site Number 484001
city: Monterrey
country: Mexico
facility: Investigational Site Number 484005
city: San Juan Del Rio
country: Mexico
facility: Investigational Site Number 484003
city: Porto
country: Portugal
facility: Investigational Site Number 620003
city: Vila Nova De Gaia
country: Portugal
facility: Investigational Site Number 620004
city: Barcelona
country: Spain
facility: Investigational Site Number 724003
city: Barcelona
country: Spain
facility: Investigational Site Number 724002
city: Hospitalet De Llobregat
country: Spain
facility: Investigational Site Number 724001
city: Lugo
country: Spain
facility: Investigational Site Number 724004
city: Majadahonda
country: Spain
facility: Investigational Site Number 724006
city: Palma De Mallorca
country: Spain
facility: Investigational Site Number 724005
city: Sabadell
country: Spain
facility: Investigational Site Number 724007
city: Ankara
country: Turkey
facility: Investigational Site Number 792005
city: Istanbul
country: Turkey
facility: Investigational Site Number 792006
city: Istanbul
country: Turkey
facility: Investigational Site Number 792001
city: Istanbul
country: Turkey
facility: Investigational Site Number 792004
city: Istanbul
country: Turkey
facility: Investigational Site Number 792003
city: Izmir
country: Turkey
facility: Investigational Site Number 792002
city: Cambridge
country: United Kingdom
facility: Investigational Site Number 826002
city: Exeter
country: United Kingdom
facility: Investigational Site Number 826003
city: Leicester
country: United Kingdom
facility: Investigational Site Number 826004
city: London
country: United Kingdom
facility: Investigational Site Number 826001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: