To Evaluate the Effect of Different Doses of SAR156597 Gi... | NCT01529853

ID	Type	Description	Link
2011-005481-37	EudraCT Number
U1111-1124-1425	Other Identifier	UTN

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Feb 6, 2012

First Submission Date that Met QC Criteria

Feb 8, 2012

First Posted Date

Feb 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jan 22, 2016

Certification/Extension First Submitted that Passed QC Review

Jan 22, 2016

Certification/Extension First Posted Date

Feb 15, 2016Estimated

Last Update Submitted Date

Jan 22, 2016

Last Update Posted Date

Feb 15, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SAR156597 dose 1	Experimental	SAR156597 dose 1, subcutaneous injection once every week	Drug: SAR156597
SAR156597 dose 2	Experimental	SAR156597 dose 2, subcutaneous injection once every week	Drug: SAR156597
SAR156597 dose 3	Experimental	SAR156597 dose 3, subcutaneous injection once every week	Drug: SAR156597
Placebo	Placebo Comparator	Placebo (for SAR156597), subcutaneous injection once every week	Drug: Placebo (for SAR156597)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SAR156597	Drug	Pharmaceutical form: solution Route of administration: subcutaneous	SAR156597 dose 1 SAR156597 dose 2 SAR156597 dose 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety/tolerability: Number of participants with Adverse events		from first dose of study drug up to Week 18

Secondary Outcomes

Measure	Description	Time Frame
Pharmacodynamic: Change in forced (expiratory) vital capacity (FVC)		from baseline to week 6
Pharmacodynamic: Change in carbon monoxide diffusing lung capacity (DLco)		from baseline to week 6

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 840008		Sacramento	California	95817	United States
Investigational Site Number 840009

ID	Term
D011658	Pulmonary Fibrosis
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases