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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529853
• Other study ID #: TDR11326
• Secondary ID: 2011-005481-37U1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 6, 2012
• Last updated: January 22, 2016
• Start date: January 2012
• Est. completion date: October 2013

Study information

• Verified date: January 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• SAR156597
Pharmaceutical form: solution Route of administration: subcutaneous
• Placebo (for SAR156597)
Pharmaceutical form: solution Route of administration: subcutaneous

Locations

Country	Name	City	State
Canada	Investigational Site Number 124003	Edmonton
Canada	Investigational Site Number 124001	Hamilton
Canada	Investigational Site Number 124002	Vancouver
Chile	Investigational Site Number 152001	Santiago
Chile	Investigational Site Number 152002	Santiago
Chile	Investigational Site Number 152003	Santiago
Mexico	Investigational Site Number 484003	Mexico City
Mexico	Investigational Site Number 484002	Monterrey
Spain	Investigational Site Number 724001	Barcelona
Spain	Investigational Site Number 724002	Barcelona
United States	Investigational Site Number 840010	Charleston	South Carolina
United States	Investigational Site Number 840006	Chicago	Illinois
United States	Investigational Site Number 840014	Cincinnati	Ohio
United States	Investigational Site Number 840009	Jacksonville	Florida
United States	Investigational Site Number 840011	Jacksonville	Florida
United States	Investigational Site Number 840004	Joliet	Illinois
United States	Investigational Site Number 840005	Maywood	Illinois
United States	Investigational Site Number 840003	Minneapolis	Minnesota
United States	Investigational Site Number 840013	New York	New York
United States	Investigational Site Number 840008	Sacramento	California
United States	Investigational Site Number 840002	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada,  Chile,  Mexico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety/tolerability: Number of participants with Adverse events		from first dose of study drug up to Week 18	Yes
Secondary	Pharmacodynamic: Change in forced (expiratory) vital capacity (FVC)		from baseline to week 6	No
Secondary	Pharmacodynamic: Change in carbon monoxide diffusing lung capacity (DLco)		from baseline to week 6	No
Secondary	Pharmacodynamic: Change in Saint George Respiratory Questionnaire (SGRQ)		from baseline to week 6	No
Secondary	Pharmacodynamic: Change in plasma levels of biomarkers		from baseline to week 18	No
Secondary	Pharmacokinetic: SAR156597 plasma concentration		from baseline to week 18	No