To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01529853
• Date of registration: 06/02/2012
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)
• Scientific title: Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Repeated Doses of SAR156597 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
• Date of first enrolment: April 2012
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01529853
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Belgium, Canada, Chile, Mexico, Spain, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria:

- Adult (aged >18 years) 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/ALTA) guidelines

Exclusion criteria:

- Forced vital capacity (FVC) <50% of predicted value Carbon monoxide diffusing lung
capacity (DLCO) (corrected for hemoglobin) <35% predicted value

- Oxygen saturation <90% by pulse oximetry while breathing ambient air at rest (sitting
position for 10 min)

- Known diagnosis of significant respiratory disorders other than IPF

- Active vasculopathy or use of vasoactive drugs

- Known HIV or chronic viral hepatitis

- Patients with active tuberculosis or latent tuberculosis infection

- Evidence of any clinically significant, severe or unstable, acute or chronically
progressive medical (other than IPF) or surgical disorder, or any condition that may
affect patient safety in the judgment of the investigator

- Clinically significant abnormal ECG at screening

- Clinically significant laboratory tests at screening

- Current history of substance and/or alcohol abuse

- Females who are lactating or who are pregnant.

- Use of any registered therapy targeted to treat IPF within 4 weeks prior to screening

- Use of any cytotoxic/immunosuppressive agent including but not limited to
azathioprine, cyclophosphamide, methotrexate and cyclosporine within 4 weeks prior to
screening

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: SAR156597

Drug: Placebo

Primary Outcome(s)

Safety/tolerability as measured by : Adverse events/treatment-emergent adverse events; Clinical laboratory evaluations [Time Frame: up to 6 months from first dose of study drug]

Secondary Outcome(s)

Change in carbon monoxide diffusing lung capacity (DLco) [Time Frame: from baseline at week 6]

Change in forced (expiratory) vital capacity (FVC) [Time Frame: from baseline at week 6]

Change in Saint George Respiratory Questionnaire (SGRQ) [Time Frame: from baseline at week 6]

Secondary ID(s)

2011-005481-37

TDR11326

U1111-1124-1425

Source(s) of Monetary Support

Please refer to primary and secondary sponsors