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

• Register: EUCTR
• Last refreshed on: 30 October 2017
• Main ID: EUCTR2014-003933-24-DE
• Date of registration: 02/03/2015
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis recherche & développement
• Public title: Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis
• Scientific 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 - ESTAIR
• Date of first enrolment: 31/08/2015
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003933-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Affiliation: Sanofi-Aventis Deutschland GmbH

• Affiliation: Sanofi-Aventis Deutschland GmbH

Key inclusion & exclusion criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion criteria:
Age =40 years.
IPF disease diagnosis >5 years.
Forced vital capacity (FVC) <40% 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 hrs 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 to be listed for lung transplantation within the next 6 months (on an active list).
History of vasculitis or connective tissue disorders.
Known human immunodeficiency virus (HIV) or chronic viral hepatitis.
Patients 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 halflives, if known (whichever is longer), or within 12 weeks for stem cell therapy.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Idiopathic pulmonary fibrosis
MedDRA version: 19.0 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Product Code: SAR156597
Pharmaceutical Form: Lyophilisate for solution for injection
Current Sponsor code: SAR156597
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Absolute change from baseline in percent predicted FVC at 52 weeks

Secondary Objective: To evaluate the efficacy of 2 dose levels of SAR156597 compared to placebo on IPF disease progression.
To evaluate the safety of 2 dose levels of SAR156597 compared to placebo in patients with IPF.

Timepoint(s) of evaluation of this end point: 1 year

Main Objective: To evaluate, in comparison with placebo, the efficacy of 2 dose levels of SAR156597 administered subcutaneously during 52 weeks on lung function of patients with IPF.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1 year

Secondary end point(s): Proportion of patients with disease progression
Number of deaths (all causes)

Secondary ID(s)

2014-003933-24-GB

DRI11772

Source(s) of Monetary Support

sanofi-aventis recherche & développement