NCT01529853

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2012

Geographic Reach
5 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 15, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

February 6, 2012

Last Update Submit

January 22, 2016

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Safety/tolerability: Number of participants with Adverse events

    from first dose of study drug up to Week 18

Secondary Outcomes (5)

  • 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

  • Pharmacodynamic: Change in Saint George Respiratory Questionnaire (SGRQ)

    from baseline to week 6

  • Pharmacodynamic: Change in plasma levels of biomarkers

    from baseline to week 18

  • Pharmacokinetic: SAR156597 plasma concentration

    from baseline to week 18

Study Arms (4)

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

SAR156597DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

SAR156597 dose 1SAR156597 dose 2SAR156597 dose 3
Placebo (for SAR156597)DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Investigational Site Number 840008

Sacramento, California, 95817, United States

Location

Investigational Site Number 840009

Jacksonville, Florida, 32209, United States

Location

Investigational Site Number 840011

Jacksonville, Florida, 32216, United States

Location

Investigational Site Number 840006

Chicago, Illinois, 60637, United States

Location

Investigational Site Number 840004

Joliet, Illinois, 60435, United States

Location

Investigational Site Number 840005

Maywood, Illinois, 60153, United States

Location

Investigational Site Number 840002

Wichita, Kansas, 67208, United States

Location

Investigational Site Number 840003

Minneapolis, Minnesota, 55455, United States

Location

Investigational Site Number 840013

New York, New York, 10021, United States

Location

Investigational Site Number 840014

Cincinnati, Ohio, 45267-0542, United States

Location

Investigational Site Number 840010

Charleston, South Carolina, 29406, United States

Location

Investigational Site Number 124003

Edmonton, T6G 2B7, Canada

Location

Investigational Site Number 124001

Hamilton, L8N 4A6, Canada

Location

Investigational Site Number 124002

Vancouver, V5Z 1M9, Canada

Location

Investigational Site Number 152003

Santiago, 750-0691, Chile

Location

Investigational Site Number 152001

Santiago, 7500710, Chile

Location

Investigational Site Number 152002

Santiago, 8380456, Chile

Location

Investigational Site Number 484003

Mexico City, 40766, Mexico

Location

Investigational Site Number 484002

Monterrey, 64460, Mexico

Location

Investigational Site Number 724001

Barcelona, 08036, Spain

Location

Investigational Site Number 724002

Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 9, 2012

Study Start

January 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

February 15, 2016

Record last verified: 2016-01

Locations

US(11)CA(3)ES(2)CL(3)ME(2)