This trial is active, not recruiting.

Condition idiopathic pulmonary fibrosis
Treatments sar156597, placebo
Phase phase 2
Sponsor Sanofi
Start date May 2015
End date August 2017
Trial size 300 participants
Trial identifier NCT02345070, 2014-003933-24, DRI11772, U1111-1154-6083


Primary 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 Idiopathic Pulmonary Fibrosis (IPF).

Secondary Objectives:

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
subcutaneous injection once every week
Pharmaceutical form:solution Route of administration: subcutaneous
subcutaneous injection once every two weeks
Pharmaceutical form:solution Route of administration: subcutaneous
(Placebo Comparator)
subcutaneous injection once every week
Pharmaceutical form:solution Route of administration: subcutaneous

Primary Outcomes

Absolute change from baseline in percent predicted FVC at 52 weeks
time frame: 1 year

Secondary Outcomes

Proportion of patients with disease progression
time frame: 1 year
Number of deaths (all causes)
time frame: 1 year

Eligibility Criteria

Male or female participants at least 40 years old.

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. 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 half-lives, if known ( whichever is longer), or within 12 weeks for stem cell therapy. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Additional Information

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
Description The total study duration of study is expected up to 68 weeks (screening period of 4 weeks, treatment period of 52 weeks, and 12 weeks of follow up).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Sanofi.