Idiopathic Pulmonary FibrosisPhase 1/2NCT01529853
To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 1/2 study testing SAR156597 in people with Idiopathic Pulmonary Fibrosis, run by Sanofi at 21 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- SAR156597
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 21 sitesin 5 countries
- Study dates
- Jan 2012to Oct 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
United States11 sites
Investigational Site Number 840010
Charleston, South Carolina, 29406
Investigational Site Number 840006
Chicago, Illinois, 60637
Investigational Site Number 840014
Cincinnati, Ohio, 45267-0542
Investigational Site Number 840009
Jacksonville, Florida, 32209
Investigational Site Number 840011
Jacksonville, Florida, 32216
Investigational Site Number 840004
Joliet, Illinois, 60435
Investigational Site Number 840005
Maywood, Illinois, 60153
Investigational Site Number 840003
Minneapolis, Minnesota, 55455
Investigational Site Number 840013
New York, New York, 10021
Investigational Site Number 840008
Sacramento, California, 95817
Investigational Site Number 840002
Wichita, Kansas, 67208
Canada3 sites
Investigational Site Number 124003
Edmonton, T6G 2B7
Investigational Site Number 124001
Hamilton, L8N 4A6
Investigational Site Number 124002
Vancouver, V5Z 1M9
Chile3 sites
Investigational Site Number 152003
Santiago, 750-0691
Investigational Site Number 152001
Santiago, 7500710
Investigational Site Number 152002
Santiago, 8380456
Mexico2 sites
Investigational Site Number 484003
Mexico City, 40766
Investigational Site Number 484002
Monterrey, 64460
Spain2 sites
Investigational Site Number 724001
Barcelona, 08036
Investigational Site Number 724002
Barcelona, 08907
About this study
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)
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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- SAR156597, Placebo (for SAR156597)
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR156597Drug
Pharmaceutical form: solution
Route of administration: subcutaneous
Placebo (for SAR156597)Drug
Pharmaceutical form: solution
Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| SAR156597 dose 1 | Experimental | SAR156597 dose 1, subcutaneous injection once every week Receives: Drug: SAR156597 |
| SAR156597 dose 2 | Experimental | SAR156597 dose 2, subcutaneous injection once every week Receives: Drug: SAR156597 |
| SAR156597 dose 3 | Experimental | SAR156597 dose 3, subcutaneous injection once every week Receives: Drug: SAR156597 |
| Placebo | Placebo comparator | Placebo (for SAR156597), subcutaneous injection once every week Receives: Drug: Placebo (for SAR156597) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/tolerability: Number of participants with Adverse events
Measured: from first dose of study drug up to Week 18
Secondary outcomes (5)
Pharmacodynamic: Change in forced (expiratory) vital capacity (FVC)
Measured: from baseline to week 6
Pharmacodynamic: Change in carbon monoxide diffusing lung capacity (DLco)
Measured: from baseline to week 6
Pharmacodynamic: Change in Saint George Respiratory Questionnaire (SGRQ)
Measured: from baseline to week 6
Pharmacodynamic: Change in plasma levels of biomarkers
Measured: from baseline to week 18
Pharmacokinetic: SAR156597 plasma concentration
Measured: from baseline to week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529853
- Sponsor's protocol ID
- TDR11326
- Other IDs
- 2011-005481-37, U1111-1124-1425
- Status last verified
- Jan 2016
- First submitted
- 6 Feb 2012
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01529853
- Acronym / sponsor ID
- TDR11326
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAR156597 dose 1 | Experimental | Drug: SAR156597SAR156597 dose 1, subcutaneous injection once every week |
| SAR156597 dose 2 | Experimental | Drug: SAR156597SAR156597 dose 2, subcutaneous injection once every week |
| SAR156597 dose 3 | Experimental | Drug: SAR156597SAR156597 dose 3, subcutaneous injection once every week |
| Placebo | Placebo comparator | Drug: Placebo (for SAR156597)Placebo (for SAR156597), subcutaneous injection once every week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR156597Pharmaceutical form: solution Route of administration: subcutaneous | Drug | SAR156597 dose 1, SAR156597 dose 2, SAR156597 dose 3 |
| Placebo (for SAR156597)Pharmaceutical form: solution Route of administration: subcutaneous | Drug | Placebo |
Primary outcome
Safety/tolerability: Number of participants with Adverse events
Time frame: from first dose of study drug up to Week 18
5 secondary outcomes
Pharmacodynamic: Change in forced (expiratory) vital capacity (FVC)
Time frame: from baseline to week 6
Pharmacodynamic: Change in carbon monoxide diffusing lung capacity (DLco)
Time frame: from baseline to week 6
Pharmacodynamic: Change in Saint George Respiratory Questionnaire (SGRQ)
Time frame: from baseline to week 6
Pharmacodynamic: Change in plasma levels of biomarkers
Time frame: from baseline to week 18
Pharmacokinetic: SAR156597 plasma concentration
Time frame: from baseline to week 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SAR156597 in people with Idiopathic Pulmonary Fibrosis, run by Sanofi at 21 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada, Chile, Mexico, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/tolerability: Number of participants with Adverse events (time frame: from first dose of study drug up to Week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016.