Clinical trial NCT01529853: To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Safety/tolerability: Number of participants with Adverse events
timeFrame: from first dose of study drug up to Week 18
Secondary outcomes:
measure: Pharmacodynamic: Change in forced (expiratory) vital capacity (FVC)
timeFrame: from baseline to week 6
measure: Pharmacodynamic: Change in carbon monoxide diffusing lung capacity (DLco)
timeFrame: from baseline to week 6
measure: Pharmacodynamic: Change in Saint George Respiratory Questionnaire (SGRQ)
timeFrame: from baseline to week 6
measure: Pharmacodynamic: Change in plasma levels of biomarkers
timeFrame: from baseline to week 18
measure: Pharmacokinetic: SAR156597 plasma concentration
timeFrame: from baseline to week 18
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Investigational Site Number 840008
state: California
city: Jacksonville
country: United States
facility: Investigational Site Number 840009
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840011
state: Florida
city: Chicago
country: United States
facility: Investigational Site Number 840006
state: Illinois
city: Joliet
country: United States
facility: Investigational Site Number 840004
state: Illinois
city: Maywood
country: United States
facility: Investigational Site Number 840005
state: Illinois
city: Wichita
country: United States
facility: Investigational Site Number 840002
state: Kansas
city: Minneapolis
country: United States
facility: Investigational Site Number 840003
state: Minnesota
city: New York
country: United States
facility: Investigational Site Number 840013
state: New York
city: Cincinnati
country: United States
facility: Investigational Site Number 840014
state: Ohio
city: Charleston
country: United States
facility: Investigational Site Number 840010
state: South Carolina
city: Edmonton
country: Canada
facility: Investigational Site Number 124003
city: Hamilton
country: Canada
facility: Investigational Site Number 124001
city: Vancouver
country: Canada
facility: Investigational Site Number 124002
city: Santiago
country: Chile
facility: Investigational Site Number 152003
city: Santiago
country: Chile
facility: Investigational Site Number 152001
city: Santiago
country: Chile
facility: Investigational Site Number 152002
city: Mexico City
country: Mexico
facility: Investigational Site Number 484003
city: Monterrey
country: Mexico
facility: Investigational Site Number 484002
city: Barcelona
country: Spain
facility: Investigational Site Number 724001
city: Barcelona
country: Spain
facility: Investigational Site Number 724002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: