To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)
Public ClinicalTrials.gov record NCT01529853. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01529853
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2011
- Primary completion
- Sep 30, 2013
- Completion
- Sep 30, 2013
- Last update posted
- Feb 14, 2016
2012 – 2013
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840008 | Sacramento | California | 95817 | — |
| Investigational Site Number 840009 | Jacksonville | Florida | 32209 | — |
| Investigational Site Number 840011 | Jacksonville | Florida | 32216 | — |
| Investigational Site Number 840006 | Chicago | Illinois | 60637 | — |
| Investigational Site Number 840004 | Joliet | Illinois | 60435 | — |
| Investigational Site Number 840005 | Maywood | Illinois | 60153 | — |
| Investigational Site Number 840002 | Wichita | Kansas | 67208 | — |
| Investigational Site Number 840003 | Minneapolis | Minnesota | 55455 | — |
| Investigational Site Number 840013 | New York | New York | 10021 | — |
| Investigational Site Number 840014 | Cincinnati | Ohio | 45267-0542 | — |
| Investigational Site Number 840010 | Charleston | South Carolina | 29406 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01529853, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 14, 2016 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01529853 live on ClinicalTrials.gov.