Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
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).
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis
