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

Sanofi

Status and phase: Completed; Phase 2; Phase 1

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Placebo (for SAR156597); Drug: SAR156597

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529853

2011-005481-37 (EudraCT Number)

U1111-1124-1425 (Other Identifier)

TDR11326

Details and patient eligibility

About

Primary Objective:

To assess in adult patients with Idiopathic Pulmonary Fibrosis (IPF) the safety and tolerability of ascending doses of SAR156597 administered subcutaneously (SC) once weekly over a 6-week period.

Secondary Objectives:

To assess in adult patients with IPF:

• The pharmacodynamic effects of SAR156597, as measured on pulmonary function tests (PFTs), pulse oximetry and patient reported outcome and peripheral blood biomarkers.
• The trough plasma concentrations of SAR156597
• The potential immunogenicity of SAR156597.

Full description

The study consists of a screening period of up to 28 days, treatment period of up to 6 weeks and a post-treatment follow-up period of up to 12 weeks. Total study duration is up to 22 weeks.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 4 patient groups, including a placebo group

SAR156597 dose 1

Experimental group

Description:

SAR156597 dose 1, subcutaneous injection once every week

Treatment:

Drug: SAR156597

SAR156597 dose 2

Experimental group

Description:

SAR156597 dose 2, subcutaneous injection once every week

Treatment:

Drug: SAR156597

SAR156597 dose 3

Experimental group

Description:

SAR156597 dose 3, subcutaneous injection once every week

Treatment:

Drug: SAR156597

Placebo

Placebo Comparator group

Description:

Placebo (for SAR156597), subcutaneous injection once every week

Treatment:

Drug: Placebo (for SAR156597)