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

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ClinicalTrials.gov Identifier: NCT01529853
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: SAR156597 Drug: Placebo (for SAR156597) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013


Arm Intervention/treatment
Experimental: SAR156597 dose 1
SAR156597 dose 1, subcutaneous injection once every week
Drug: SAR156597

Pharmaceutical form: solution

Route of administration: subcutaneous


Experimental: SAR156597 dose 2
SAR156597 dose 2, subcutaneous injection once every week
Drug: SAR156597

Pharmaceutical form: solution

Route of administration: subcutaneous


Experimental: SAR156597 dose 3
SAR156597 dose 3, subcutaneous injection once every week
Drug: SAR156597

Pharmaceutical form: solution

Route of administration: subcutaneous


Placebo Comparator: Placebo
Placebo (for SAR156597), subcutaneous injection once every week
Drug: Placebo (for SAR156597)

Pharmaceutical form: solution

Route of administration: subcutaneous





Primary Outcome Measures :
  1. Safety/tolerability: Number of participants with Adverse events [ Time Frame: from first dose of study drug up to Week 18 ]

Secondary Outcome Measures :
  1. Pharmacodynamic: Change in forced (expiratory) vital capacity (FVC) [ Time Frame: from baseline to week 6 ]
  2. Pharmacodynamic: Change in carbon monoxide diffusing lung capacity (DLco) [ Time Frame: from baseline to week 6 ]
  3. Pharmacodynamic: Change in Saint George Respiratory Questionnaire (SGRQ) [ Time Frame: from baseline to week 6 ]
  4. Pharmacodynamic: Change in plasma levels of biomarkers [ Time Frame: from baseline to week 18 ]
  5. Pharmacokinetic: SAR156597 plasma concentration [ Time Frame: from baseline to week 18 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529853


Locations
Show Show 21 study locations
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01529853    
Other Study ID Numbers: TDR11326
2011-005481-37 ( EudraCT Number )
U1111-1124-1425 ( Other Identifier: UTN )
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial